VR Smoking Cessation During a Dental Hygiene Visit

NCT04524533 | Completed Results

• 2 other identifiers: H-403684UH3DE028866-02
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Smoking Cessation

Keywords

video-based smoking cessation; smoking cessation evidence-based treatments (EBTs); text messages; dental cleaning; smoking cessation

Outcome Measures

Primary Outcomes (5)

• 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).

  7 months

• 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.

  7 months

• 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).

  7 months

• 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).

  7 months

• 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).

  7 months

Secondary Outcomes (6)

• Self-report 7-day Point Prevalence Smoking Abstinence

  7 months

• Verified 7-day Point Prevalence Smoking Abstinence

  7 months

• Motivation to Quit Smoking

  7 months

• Any Quit Smoking Attempt

  7 months

• Participant's Satisfaction

  within 10 days after the dental clinic visit.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Experimental smoking cessation video; Other: Brochure of smoking cessation EBTs; Behavioral: Tailored text message program

Control group

ACTIVE COMPARATOR

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.

Behavioral: Control video; Other: Brochure of smoking cessation EBTs; Other: Assessment text messages

Interventions

Experimental smoking cessation video BEHAVIORAL

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.

Intervention group

Control video BEHAVIORAL

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

Control group

Brochure of smoking cessation EBTs OTHER

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

Control group; Intervention group

Tailored text message program BEHAVIORAL

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.

Intervention group

Assessment text messages OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?")
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Henry M Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 41526906 DERIVED

• 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.

  PMID: 35641925 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Belinda Borrelli, PhD
• Organization: Henry M. Goldman School of Dental Medicine

belindab@bu.edu

617-358-3358

Study Officials

• Belinda Borrelli, PhD

  Henry M Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research assistants who are collecting outcome data will be masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: January 4, 2021
• Primary Completion: March 19, 2025
• Study Completion: September 1, 2025
• Last Updated: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)