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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1239 participants

Primary outcome timeframe

6 months post baseline

Results posted on

2026-07-24

Participant Flow

Unit of analysis: Dental Practices

Participant milestones

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

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 baseline

Population: 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

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 baseline

Population: This outcome only applies to patient participants

Proportion reporting no smoking in the 7 days prior to the 1-month follow-up

Outcome measures

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
64 Participants
Interval 1.03 to 2.88
62 Participants
Interval 1.03 to 2.88

SECONDARY outcome

Timeframe: 3 months post baseline

Population: This outcome only applies to patient participants.

Proportion reporting no smoking in the 7 days prior to the 3-month follow-up

Outcome measures

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 baseline

Population: 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

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 baseline

Population: This outcome only applies to patient participants.

Change in cigarettes smoked per day from baseline to the 6 month follow-up

Outcome measures

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 baseline

Population: This outcome only applies to patient participants.

Proportion reporting using nicotine patch or nicotine lozenge in the 6 months following baseline

Outcome measures

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 baseline

Population: 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

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 baseline

Population: 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

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

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

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

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 recruitment

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 feasibility of the intervention of the study. Scores range from 1-5 with higher scores indicating greater feasibility.

Outcome measures

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

Serious events: 0 serious events
Other events: 543 other events
Deaths: 0 deaths

Nicotine Replacement Therapy Patients

Serious events: 0 serious events
Other events: 339 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 612-873-6856

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place