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Smoking CessationNCT04524533

VR Smoking Cessation During a Dental Hygiene Visit

A study testing Experimental smoking cessation video, Brochure of smoking cessation EBTs and Tailored text message program in people with Smoking Cessation, run by Boston University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Experimental smoking cessation video, Brochure of smoking cessation EBTs and Tailored text message program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteUnited States
Study dates
4 Jan 2021to 1 Sep 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient of the Boston University, Henry M Goldman School of Dental Medicine treatment center with an upcoming dental hygiene appointment (dental prophylaxis or scaling and root planing)
  • Self-reported smoking 100 cigarettes or more (not including e-cigarettes or vaping) in lifetime
  • Self-reported smoking any cigarette (not including e-cigarettes or vaping) in the preceding week
  • Self-reported cigarettes (not including e-cigarettes or vaping) 'some days', 'most days' or 'every day' in the preceding week
  • Is able to understand written and spoken study materials
  • Score of 'Never,' 'Rarely' or 'Sometimes' on the validated single-item literacy screener ("How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor, dentist, or pharmacy?")
Show all 12Show fewer
  • Self-reported visual capacity to watch a video as indicated by the score 'Some difficulty' or 'No difficulty' to: "How much difficulty do you have with your vision, even when wearing glasses?"
  • Self-reported ability to wear headphones that are inserted partially inside the ear
  • Self-reported use of text messaging at least once in the preceding month
  • Self-reported access to necessary resources for intervention: Cell phone capable of text messaging
  • Live in Massachusetts
  • Stated willingness to comply with text message program procedures (receive and respond to text messages for 4-weeks)

Who cannot join

  • Participation in another treatment or intervention study for smoking cessation or research involving text messaging
  • Current use of medications for smoking cessation or smoking reduction (nicotine replacement product, or non-nicotine medications) whether prescribed or not
  • Failure to complete the pre-dental clinic appointment procedure before the start of the dental appointment (opt-into the text message program and complete the baseline questionnaire)
  • Failure to show up to scheduled dental appointment at the clinic
  • Previous participation in the pilot phase
  • Could not watch video during dental appointment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Henry M Goldman School of Dental Medicine

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Delivery of a Smoking Cessation Induction Intervention Via Virtual Reality (VR) Headset During a Dental Cleaning: Randomized Controlled Trial

The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment.

Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group

Read the detailed description

Approximately 400 patients who have a scheduled prophylaxis, root planing and scaling dental appointment at the BUGSDM patient treatment center will be recruited and enrolled in the randomized controlled trial. Participants who complete the baseline survey will be randomized to either the intervention or control group. The intervention group will watch one of two smoking cessation videos during the appointment (depending on readiness to quit), receive a brochure about EBTs for smoking cessation, and participate in a 4-week tailored text message program designed to motivate EBT utilization. After the 4-week text message program, the intervention group will receive monthly assessment text messages for six months. The control group will watch a control video during the appointment, receive the same brochure about EBTs as the intervention group, and participate in an assessment-only 4-week text message program. All videos are approximately 10 minutes long.

After the dental clinic appointment, all participants will complete an online questionnaire and begin the 4-week text message program.

At the end of the 4-week text message program, and 3 and 6 months later, all participants will complete online questionnaires.

Primary Aim 1: To test the efficacy of the intervention vs. control in increasing utilization of EBTs over the course of follow-up (7-months). Hypothesis 1.1: Smokers randomized to the intervention will be more likely to engage with (contact) EBTs. Hypothesis 1.2: Smokers randomized to the intervention will have greater treatment utilization (e.g., more days in the text message program, more days using smoking cessation medication, and more quitline counseling sessions, greater number of EBTs).

Secondary Aims:

Aim 2: To test the effect of the intervention vs. controls on quit attempts and on motivation to quit. Hypothesis 2: Smokers randomized to the intervention will have more quit attempts and higher motivation to quit.

Aim 3: To test the efficacy of the intervention vs controls on biochemically verified abstinence. Hypothesis 3: Smokers randomized to the intervention will have higher quit rates at follow-up.

Aim 4: To assess the mechanisms through which the intervention effects occur (social cognitive mediators) and to identify subpopulations for whom intervention effects differ (moderators, e.g., readiness to quit, gender, race/ethnicity). Hypothesis 4: The intervention will directly affect the putative mediators, which will in turn affect EBT utilization. The role of moderators will be exploratory.

Being tested
Experimental smoking cessation video, Control video, Brochure of smoking cessation EBTs, Tailored text message program, Assessment text messages
Keywords
video-based smoking cessation, smoking cessation evidence-based treatments (EBTs), text messages, dental cleaning, smoking cessation
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental smoking cessation videoBehavioural

    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.

  • Control videoBehavioural

    Participants randomized to the control group will watch a 10 minute video.

  • Brochure of smoking cessation EBTsOther

    All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.

  • Tailored text message programBehavioural

    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.

  • Assessment text messagesOther

    Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.

Study groups in NCT04524533
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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.
Receives: Behavioral: Experimental smoking cessation video; Other: Brochure of smoking cessation EBTs; Behavioral: Tailored text message program
Control groupActive comparatorParticipants 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.
Receives: Behavioral: Control video; Other: Brochure of smoking cessation EBTs; Other: Assessment text messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation

    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).

    Measured: 7 months

  2. Verified Use of Any EBT for Smoking Cessation

    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.

    Measured: 7 months

  3. Use of Combination EBT for Smoking Cessation

    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).

    Measured: 7 months

  4. Number of EBT Used for Smoking Cessation

    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).

    Measured: 7 months

  5. Text Message (TM) Data Use of Any EBT for Smoking Cessation

    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).

    Measured: 7 months

Secondary outcomes (6)
  1. Self-report 7-day Point Prevalence Smoking Abstinence

    Participants self-report of no smoking, not even a puff, in the preceding 7 days.

    Measured: 7 months

  2. Verified 7-day Point Prevalence Smoking Abstinence

    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).

    Measured: 7 months

  3. Motivation to Quit Smoking

    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.

    Measured: 7 months

  4. Any Quit Smoking Attempt

    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)

    Measured: 7 months

  5. Participant's Satisfaction

    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.

    Measured: within 10 days after the dental clinic visit.

  6. EBT Utilization Index Score

    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.

    Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start4 Jan 2021
  3. Primary completion19 Mar 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524533
Sponsor's protocol ID
H-40368
Other IDs
4UH3DE028866-02
Status last verified
Apr 2026
First submitted
20 Aug 2020
Last updated
26 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: To enable verification of outcome measures, participant's data will be shared with the smoker quitline service and with the industry partner managing the text message programs.

Publications

  • Hart NJ, Goodman MS, Park H, Endrighi R, Jurasic MM, Cabral HJ, Borrelli B. Factors associated with dental fear and anxiety among smokers in urban dental clinics: a cross-sectional analysis. BMC Oral Health. 2026 Jan 13;26(1):263. doi: 10.1186/s12903-026-07682-3.

    PubMed 41526906
  • Borrelli B, Endrighi R, Jurasic MM, Hernandez H, Jones E, Ospina J, Cabral HJ, Quintiliani LM, Werntz S. A smoking cessation induction intervention via virtual reality headset during a dental cleaning: protocol for a randomized controlled trial. BMC Public Health. 2022 May 31;22(1):1074. doi: 10.1186/s12889-022-13427-y.

    PubMed 35641925

Questions about this trial

What is this clinical trial studying?

A study testing Experimental smoking cessation video, Brochure of smoking cessation EBTs and Tailored text message program in people with Smoking Cessation, run by Boston University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of Any Evidence-Based Treatment (EBT) for Smoking Cessation (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04524533, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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