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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

440 participants

Primary outcome timeframe

7 months

Results posted on

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

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

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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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 months

Population: 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

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

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 months

Population: 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

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

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

Control Group

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

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

Phone: 617-358-3358

Results disclosure agreements

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