Trial Outcomes & Findings for Free Samples for Health (NCT NCT05627596)
NCT ID: NCT05627596
Last Updated: 2026-07-24
Results Overview
Percentage reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million
COMPLETED
PHASE2
1239 participants
6 months post baseline
2026-07-24
Participant Flow
Unit of analysis: Dental Practices
Participant milestones
| Measure |
Electric Toothbrush Patients
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Overall Study
STARTED
|
710 29
|
529 30
|
|
Overall Study
Eligible for CO test
|
123 29
|
72 30
|
|
Overall Study
CO results returned
|
82 29
|
53 30
|
|
Overall Study
Patient participants
|
710 29
|
486 30
|
|
Overall Study
Practitioner participants
|
0 0
|
43 30
|
|
Overall Study
COMPLETED
|
526 29
|
353 30
|
|
Overall Study
NOT COMPLETED
|
184 0
|
176 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
Baseline characteristics by cohort
| Measure |
Electric Toothbrush
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy
n=529 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges. Participants in this arm include patients assigned to the Nicotine Replacement Therapy intervention and practitioners delivering the Nicotine Replacement Therapy Intervention.
|
Total
n=1239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patients
|
47.34 years
STANDARD_DEVIATION 13.83 • n=710 Participants • The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
|
47.46 years
STANDARD_DEVIATION 13.08 • n=486 Participants • The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
|
47.39 years
STANDARD_DEVIATION 13.53 • n=1196 Participants • The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
|
|
Age, Continuous
practitioners
|
—
|
43.4 years
STANDARD_DEVIATION 12.4 • n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
|
43.4 years
STANDARD_DEVIATION 12.4 • n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey plus practitioners in the Nicotine Replacement therapy group. Information for practitioners was drawn from administrative data.
|
|
Sex/Gender, Customized
Female patients
|
415 Participants
n=710 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
291 Participants
n=486 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
706 Participants
n=1196 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
|
Sex/Gender, Customized
Male patients
|
291 Participants
n=710 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
195 Participants
n=486 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
486 Participants
n=1196 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
|
Sex/Gender, Customized
missing/other patients
|
4 Participants
n=710 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
0 Participants
n=486 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
4 Participants
n=1196 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
|
Sex/Gender, Customized
Male practitioners
|
0 Participants
Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
17 Participants
n=43 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
17 Participants
n=43 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
|
Sex/Gender, Customized
Female practitioners
|
0 Participants
Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
26 Participants
n=43 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
26 Participants
n=43 Participants • Participants were divided into two groups, patients, and providers. Frequency of gender categories was calculated separately for patients and providers.
|
|
Ethnicity (NIH/OMB)
patients · Hispanic or Latino
|
61 Participants
n=710 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
28 Participants
n=486 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
89 Participants
n=1196 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Ethnicity (NIH/OMB)
patients · Not Hispanic or Latino
|
638 Participants
n=710 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
452 Participants
n=486 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
1090 Participants
n=1196 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Ethnicity (NIH/OMB)
patients · Unknown or Not Reported
|
11 Participants
n=710 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
6 Participants
n=486 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
17 Participants
n=1196 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Ethnicity (NIH/OMB)
Practitioners · Hispanic or Latino
|
0 Participants
The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
1 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
1 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Ethnicity (NIH/OMB)
Practitioners · Not Hispanic or Latino
|
0 Participants
The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
42 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
42 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Ethnicity (NIH/OMB)
Practitioners · Unknown or Not Reported
|
0 Participants
The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
0 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
0 Participants
n=43 Participants • The participants analyzed include all patient participants who completed the baseline survey and all practitioners in the nicotine replacement therapy sampling group. Practitioner data was drawn from administrative data.
|
|
Region of Enrollment
United States
|
710 Participants
n=710 Participants • The top table indicates patients, the bottom row indicates practitioners.
|
529 Participants
n=529 Participants • The top table indicates patients, the bottom row indicates practitioners.
|
1239 Participants
n=1239 Participants • The top table indicates patients, the bottom row indicates practitioners.
|
|
Baseline survey completion
Patients
|
710 Participants
n=710 Participants • The participants analyzed include all participants who completed the baseline survey.
|
486 Participants
n=486 Participants • The participants analyzed include all participants who completed the baseline survey.
|
1196 Participants
n=1196 Participants • The participants analyzed include all participants who completed the baseline survey.
|
|
Baseline survey completion
practitioners
|
0 Participants
The participants analyzed include all participants who completed the baseline survey.
|
36 Participants
n=43 Participants • The participants analyzed include all participants who completed the baseline survey.
|
36 Participants
n=43 Participants • The participants analyzed include all participants who completed the baseline survey.
|
|
Organizational Readiness for Change Scale
|
—
|
53.78 units on a scale
STANDARD_DEVIATION 7.45 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey (N=36). The patient participants were not asked to answer this measure.
|
53.78 units on a scale
STANDARD_DEVIATION 7.45 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey (N=36). The patient participants were not asked to answer this measure.
|
|
Acceptability of Intervention Measure
|
—
|
4.47 units on a scale
STANDARD_DEVIATION 0.58 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
4.47 units on a scale
STANDARD_DEVIATION 0.58 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
|
Intervention Appropriateness Measure
|
—
|
4.42 units on a scale
STANDARD_DEVIATION 0.58 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
4.42 units on a scale
STANDARD_DEVIATION 0.58 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
|
Feasibility of Intervention Measure
|
—
|
4.38 units on a scale
STANDARD_DEVIATION 0.62 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
4.38 units on a scale
STANDARD_DEVIATION 0.62 • n=36 Participants • The participants analyzed include all practitioners who completed the baseline survey. The patient participants were not asked to answer this measure.
|
PRIMARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
Percentage reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
7-day Biochemically Confirmed Point Prevalence Abstinence
|
57 Participants
Interval 0.65 to 2.09
|
41 Participants
Interval 0.65 to 2.09
|
SECONDARY outcome
Timeframe: 1 month post baselinePopulation: This outcome only applies to patient participants
Proportion reporting no smoking in the 7 days prior to the 1-month follow-up
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
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|---|---|---|
|
7-day Self-reported Point Prevalence Abstinence
|
64 Participants
Interval 1.03 to 2.88
|
62 Participants
Interval 1.03 to 2.88
|
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: This outcome only applies to patient participants.
Proportion reporting no smoking in the 7 days prior to the 3-month follow-up
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
7-day Self-reported Point Prevalence Abstinence
|
106 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
proportion reporting a quit attempt of 24 hours or longer in duration over the course of the study
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
24-hour Intentional Quit Attempts
|
346 Participants
|
284 Participants
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
Change in cigarettes smoked per day from baseline to the 6 month follow-up
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Smoking Heaviness
|
-3.42 cigarettes per day
Standard Deviation 4.76
|
-5.12 cigarettes per day
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Nicotine Replacement Therapy Utilization
|
90 Participants
Interval 5.29 to 10.31
|
243 Participants
Interval 5.29 to 10.31
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
Single item measure of perceived nicotine replacement therapy safety, "Nicotine replacement therapy products (also known as NRT) include the nicotine patch, gum, lozenge, nasal spray, and inhaler. On a scale of 1 to 5, where 1 is not at all and 5 is very, how concerned are you about the safety of NRT products?" For this outcome, we report the change from baseline to the 6 month follow-up.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Perceived Nicotine Replacement Therapy Safety
|
-0.70 units on a scale
Standard Deviation 1.65
|
-0.23 units on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: This outcome only applies to patient participants.
Single item measure of perceived nicotine replacement therapy efficacy, "On a scale of 1 to 5, where 1 is not at all, and 5 is very much, how much do you think NRT products improve a smoker's chance of quitting successfully?" For this outcome, we report the change from baseline to the 6 month follow-up.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=710 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Perceived Nicotine Replacement Therapy Efficacy
|
-0.28 units on a scale
Standard Deviation 1.41
|
-0.04 units on a scale
Standard Deviation 1.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)Population: This outcome only applies to practitioner participants.
Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the readiness for implementing organizational change (in this case, nicotine replacement therapy sampling). Scores range from 12-60 with higher scores indicating greater readiness for change.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=31 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Organizational Readiness for Change
|
50.58 units on a scale
Standard Deviation 11.29
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)Population: This outcome only applies to practitioner participants.
Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the acceptability of the intervention of the study (Nicotine replacement therapy sampling). Range is 1-5 with higher scores indicating greater acceptability.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=31 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Acceptability of Intervention Measure
|
4.46 units on a scale
Standard Deviation 0.63
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of site enrollment to meeting target recruitment goal or study/site termination (an average of 1 year following site enrollment)Population: This outcome only applies to practitioner participants.
Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the intervention appropriateness of the study. cores range from 1-5 with 5 indicating greater appropriateness of nicotine replacement therapy sampling.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=31 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Intervention Appropriateness Measure
|
4.46 units on a scale
Standard Deviation 0.69
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From initiation of site enrollment to meeting target recruitment goal or study/site termination, an average of 1 year following recruitmentPopulation: This outcome only applies to practitioner participants.
Rating on a scale of 1 (completely disagree) to 5 (completely agree) on level of agreement with statements regarding the feasibility of the intervention of the study. Scores range from 1-5 with higher scores indicating greater feasibility.
Outcome measures
| Measure |
Electric Toothbrush Patients
n=31 Participants
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Feasibility of Intervention Measure
|
4.32 units on a scale
Standard Deviation 0.81
|
—
|
Adverse Events
Electric Toothbrush Patients
Nicotine Replacement Therapy Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electric Toothbrush Patients
n=710 participants at risk
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
|
Nicotine Replacement Therapy Patients
n=486 participants at risk
Participants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth at 1M
|
31.1%
221/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
25.3%
123/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Dry mouth at 3M
|
28.7%
204/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
25.1%
122/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Dry mouth at 6M
|
26.2%
186/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
20.2%
98/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw soreness at 1M
|
10.7%
76/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
9.9%
48/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw soreness at 3M
|
10.1%
72/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
8.8%
43/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw soreness at 6M
|
8.5%
60/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
6.0%
29/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Excessive saliva at 1M
|
6.3%
45/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.2%
35/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Excessive saliva at 3M
|
9.0%
64/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.6%
37/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Excessive saliva at 6M
|
7.0%
50/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
6.2%
30/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Insomnia at 1M
|
35.4%
251/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
30.2%
147/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Insomnia at 3M
|
35.4%
251/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
26.1%
127/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Insomnia at 6M
|
30.0%
213/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
25.7%
125/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Hiccups at 1M
|
8.2%
58/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.4%
36/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Hiccups at 3M
|
9.7%
69/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
9.7%
47/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Hiccups at 6M
|
8.5%
60/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
9.7%
47/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Burning in throat at 1M
|
6.5%
46/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
6.8%
33/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Burning in throat at 3M
|
7.3%
52/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
8.6%
42/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Burning in throat at 6M
|
5.4%
38/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
8.2%
40/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin irritation at 1M
|
6.8%
48/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
8.2%
40/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin irritation at 3M
|
10.3%
73/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
9.5%
46/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin irritation at 6M
|
7.0%
50/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
10.5%
51/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin redness at 1M
|
4.2%
30/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.6%
37/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin redness at 3M
|
6.8%
48/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.8%
38/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Musculoskeletal and connective tissue disorders
Skin redness at 6M
|
5.2%
37/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
9.3%
45/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Skin itchiness at 1M
|
10.3%
73/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
12.3%
60/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Skin itchiness at 3M
|
14.2%
101/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
11.9%
58/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Skin itchiness at 6M
|
10.4%
74/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
13.2%
64/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Nausea at 6M
|
16.9%
120/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
18.5%
90/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Headache at 1M
|
39.6%
281/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
34.4%
167/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Headache at 3M
|
39.3%
279/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
33.1%
161/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Headache at 6M
|
36.8%
261/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
29.4%
143/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Heartburn at 1M
|
26.3%
187/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
23.5%
114/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Heartburn at 3M
|
27.5%
195/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
23.7%
115/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Heartburn at 6M
|
24.2%
172/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
22.8%
111/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Mouth soreness at 1M
|
14.9%
106/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
12.8%
62/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Mouth soreness at 3M
|
11.8%
84/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
8.6%
42/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Mouth soreness at 6M
|
10.6%
75/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
7.6%
37/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Dizziness at 1M
|
21.0%
149/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
21.4%
104/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Dizziness at 3M
|
21.4%
152/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
20.4%
99/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Nervous system disorders
Dizziness at 6M
|
20.6%
146/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
17.3%
84/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
Gastrointestinal disorders
Nausea at 1M
|
15.1%
107/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
20.6%
100/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
|
General disorders
Nausea at 3M
|
18.7%
133/710 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
21.2%
103/486 • from baseline to six-months
Deaths or serious adverse events such as hospitalizations; adverse events were only systematically collected for patients.
|
Additional Information
Sandra J. Japuntich/Principal Investigator
University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place