Trial Outcomes & Findings for VR Smoking Cessation During a Dental Hygiene Visit (NCT NCT04524533)
NCT ID: NCT04524533
Last Updated: 2026-05-26
Results Overview
Self-reported use of combination EBT defined according to clinical guidelines as use of a pharmacologic product (NRT or non-nicotine medications) combined with behavioral support (counseling, quitline, or text-message program).
COMPLETED
NA
440 participants
7 months
2026-05-26
Participant Flow
Recruitment occurred using electronic dental records of dental patients at two university-affiliated dental clinics.
N=695 provided informed consent to participation; n=240 were excluded before randomization (n=63 dental clinic cancelled appointment/changed procedure; n=12 did not opt into the text message program; n=52 did not complete baseline questionnaire; n=58 did not attend the clinic appointment; n=18 rescreened ineligible in-clinic; n=22 no longer interested; n=15 study team cancelled appointment). N=455 randomized; n=15 were ineligible post-randomization (dental provider cancelled/changed procedure)
Participant milestones
| Measure |
Intervention Group
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
Experimental smoking cessation video: Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Tailored text message program: Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
|
Control Group
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
Control video: Participants randomized to the control group will watch a 10 minute video.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Assessment text messages: Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
224
|
|
Overall Study
COMPLETED
|
213
|
224
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Intervention Group
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
Experimental smoking cessation video: Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Tailored text message program: Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
|
Control Group
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
Control video: Participants randomized to the control group will watch a 10 minute video.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Assessment text messages: Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
VR Smoking Cessation During a Dental Hygiene Visit
Baseline characteristics by cohort
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
Experimental smoking cessation video: Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Tailored text message program: Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
Control video: Participants randomized to the control group will watch a 10 minute video.
Brochure of smoking cessation EBTs: All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
Assessment text messages: Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 13.4 • n=20 Participants
|
47.5 years
STANDARD_DEVIATION 12.7 • n=32 Participants
|
47.5 years
STANDARD_DEVIATION 13.0 • n=64 Participants
|
|
Sex/Gender, Customized
Female
|
107 Participants
n=20 Participants
|
101 Participants
n=32 Participants
|
208 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Male
|
106 Participants
n=20 Participants
|
119 Participants
n=32 Participants
|
225 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Other
|
3 Participants
n=20 Participants
|
3 Participants
n=32 Participants
|
6 Participants
n=64 Participants
|
|
Sex/Gender, Customized
Not reported
|
0 Participants
n=20 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=20 Participants
|
30 Participants
n=32 Participants
|
55 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=20 Participants
|
190 Participants
n=32 Participants
|
379 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=20 Participants
|
7 Participants
n=32 Participants
|
14 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=20 Participants
|
45 Participants
n=32 Participants
|
96 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=20 Participants
|
137 Participants
n=32 Participants
|
261 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=20 Participants
|
20 Participants
n=32 Participants
|
37 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=20 Participants
|
13 Participants
n=32 Participants
|
30 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=20 Participants
|
224 participants
n=32 Participants
|
440 participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data.
Self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study. EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline).
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation
6-months
|
70 Participants
|
46 Participants
|
|
Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation
1-month
|
75 Participants
|
49 Participants
|
|
Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation
3-months
|
76 Participants
|
49 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: No data were available for 4 participants in the intervention group.
Objectively verified use of the following EBT: the text message program SmokefreeTXT and/or the Massachusetts state quitline. Verification of use will occur through review of usage databases from the vendors.
Outcome measures
| Measure |
Intervention Group
n=212 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Verified Use of Any EBT for Smoking Cessation
|
64 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data.
Self-reported use of combination EBT defined according to clinical guidelines as use of a pharmacologic product (NRT or non-nicotine medications) combined with behavioral support (counseling, quitline, or text-message program).
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Use of Combination EBT for Smoking Cessation
6-months
|
11 Participants
|
5 Participants
|
|
Use of Combination EBT for Smoking Cessation
1-month
|
13 Participants
|
7 Participants
|
|
Use of Combination EBT for Smoking Cessation
3-months
|
13 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data.
Self-reported use of the total number of EBT computed by counting the different type of EBTs used for smoking cessation in any combination (range 0 - 4).
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Number of EBT Used for Smoking Cessation
6-months · 2 EBTs
|
6 Participants
|
4 Participants
|
|
Number of EBT Used for Smoking Cessation
6-months · 3 EBTs
|
4 Participants
|
1 Participants
|
|
Number of EBT Used for Smoking Cessation
6-months · 4 EBTs
|
1 Participants
|
0 Participants
|
|
Number of EBT Used for Smoking Cessation
1-month · 1 EBT
|
61 Participants
|
40 Participants
|
|
Number of EBT Used for Smoking Cessation
1-month · 2 EBTs
|
9 Participants
|
7 Participants
|
|
Number of EBT Used for Smoking Cessation
1-month · 4 EBTs
|
0 Participants
|
1 Participants
|
|
Number of EBT Used for Smoking Cessation
3-months · 0 EBT
|
120 Participants
|
161 Participants
|
|
Number of EBT Used for Smoking Cessation
3-months · 1 EBT
|
62 Participants
|
41 Participants
|
|
Number of EBT Used for Smoking Cessation
3-months · 3 EBTs
|
3 Participants
|
1 Participants
|
|
Number of EBT Used for Smoking Cessation
3-months · 4 EBTs
|
0 Participants
|
0 Participants
|
|
Number of EBT Used for Smoking Cessation
6-months · 1 EBT
|
59 Participants
|
41 Participants
|
|
Number of EBT Used for Smoking Cessation
1-month · 0 EBT
|
131 Participants
|
172 Participants
|
|
Number of EBT Used for Smoking Cessation
1-month · 3 EBTs
|
5 Participants
|
1 Participants
|
|
Number of EBT Used for Smoking Cessation
3-months · 2 EBTs
|
11 Participants
|
7 Participants
|
|
Number of EBT Used for Smoking Cessation
6-months · 0 EBT
|
125 Participants
|
170 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 435 participants provided data. At 3-months, 416 participants provided data. At 6-months, 417 participants provided data.
TM and questionnaire assessment of self-reported use of any Evidence-Based Treatment (EBT) for smoking cessation. Participants indicated whether they used any EBT during the study (for the intervention group, responses were also obtained through text message assessments during the course of the study). EBT is defined according to clinical practice guidelines and include: counseling (individual or group counseling at a clinic or community center and telehealth), a telephone quit line (Massachusetts quitline), quit smoking text-message programs (National Cancer Institute's "SmokefreeTXT" or Massachusetts quitline text program), Nicotine Replacement Therapy (patch, gum, lozenge, inhaler), and non-nicotine quit smoking medications (bupropion or varenicline).
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Text Message (TM) Data Use of Any EBT for Smoking Cessation
1-month
|
152 Participants
|
49 Participants
|
|
Text Message (TM) Data Use of Any EBT for Smoking Cessation
3-months
|
115 Participants
|
49 Participants
|
|
Text Message (TM) Data Use of Any EBT for Smoking Cessation
6-months
|
106 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 425 participants provided data. At 3-months, 406 participants provided data. At 6-months, 407 participants provided data.
Participants self-report of no smoking, not even a puff, in the preceding 7 days.
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Self-report 7-day Point Prevalence Smoking Abstinence
1-month
|
39 Participants
|
22 Participants
|
|
Self-report 7-day Point Prevalence Smoking Abstinence
3-months
|
50 Participants
|
37 Participants
|
|
Self-report 7-day Point Prevalence Smoking Abstinence
6-months
|
54 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 425 participants provided data. At 3-months, 406 participants provided data. At 6-months, 407 participants provided data.
Participants self-report of no smoking, not even a puff, in the preceding 7 days will be biochemically confirmed through salivary cotinine analysis using the clinically recommended cut off level (\<15 ng/mL = verified abstinent).
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Verified 7-day Point Prevalence Smoking Abstinence
1-month
|
14 Participants
|
6 Participants
|
|
Verified 7-day Point Prevalence Smoking Abstinence
3-months
|
19 Participants
|
12 Participants
|
|
Verified 7-day Point Prevalence Smoking Abstinence
6-months
|
19 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: Includes only the subsample of participants who did not quit smoking (non-abstinent) during the study. Participants who quit smoking are not included.
Self-reported motivation to quit smoking within 30 days. Participants who did not quit smoking (non-abstinent) during the study indicated whether they are ready to quit smoking within 30 days.
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Motivation to Quit Smoking
6-months
|
34 Participants
|
33 Participants
|
|
Motivation to Quit Smoking
1-month
|
58 Participants
|
41 Participants
|
|
Motivation to Quit Smoking
3-months
|
32 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 7 monthsPopulation: At 1-month, 426 participants provided data. At 3-months, 398 participants provided data. At 6-months, 404 participants provided data.
Self-reported attempts to quit smoking for at least 24 hours. Participants indicated whether they made any attempt to quit smoking for at least 24 hours because they were trying to quit (not due to illness or hospitalization)
Outcome measures
| Measure |
Intervention Group
n=216 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=224 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Any Quit Smoking Attempt
6-months
|
99 Participants
|
105 Participants
|
|
Any Quit Smoking Attempt
1-month
|
112 Participants
|
92 Participants
|
|
Any Quit Smoking Attempt
3-months
|
99 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: within 10 days after the dental clinic visit.Population: 428 participants provided data.
A 10-item questionnaire measuring satisfaction with the video experience (6 items) and satisfaction with the virtual reality (VR) headset experience (4 items). Each item is rated on a 1 ("not satisfied at all") to 7 ("very satisfied") scale and average scores are computed for each scale. Higher scores mean a better outcome.
Outcome measures
| Measure |
Intervention Group
n=211 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=217 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
Participant's Satisfaction
Video experience scale
|
5.9 Score on a satisfaction questionnaire
Standard Deviation 1.1
|
5.6 Score on a satisfaction questionnaire
Standard Deviation 1.1
|
|
Participant's Satisfaction
VR headset experience scale
|
5.9 Score on a satisfaction questionnaire
Standard Deviation 1.2
|
5.6 Score on a satisfaction questionnaire
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: up to 7 monthsPopulation: Subgroup of participants (n=178) who indicated use of any of the following EBTs: clinic or phone counseling or pharmacotherapy or had objective NCI texting usage data and also provided data on dose of treatment utilized (aggregated across one, three, and six-month surveys).
The utilization index score (UIS) is computed as the sum of the utilization dose of each evidence-based treatment (EBT) for smoking cessation used by participants (range 0 - 100). Higher scores mean a better outcome.
Outcome measures
| Measure |
Intervention Group
n=105 Participants
Participants randomized into the intervention arm will watch smoking cessation videos (ready to quit or not ready to quit) during a dental cleaning clinic visit, receive a brochure about EBTs, and participate in a 4-week text message program which consists of automated and tailored text messages to motivate EBT utilization. After the 4-week program, the intervention group will receive monthly assessment text messages.
|
Control Group
n=73 Participants
Participants randomized into the control arm will watch a control video during a dental hygiene visit and receive a brochure about EBTs, and a 4-week assessment-only text message program.
|
|---|---|---|
|
EBT Utilization Index Score
|
19.6 Scores on a treatment utilization scale
Standard Deviation 14.1
|
13.5 Scores on a treatment utilization scale
Standard Deviation 13.6
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Belinda Borrelli, PhD
Henry M. Goldman School of Dental Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place