NCT04524533

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

August 20, 2020

Last Update Submit

August 30, 2025

Conditions

Keywords

video-based smoking cessationsmoking cessation evidence-based treatments (EBTs)text messagesdental cleaningsmoking cessation

Outcome Measures

Primary Outcomes (3)

  • Utilization of Massachusetts State Quitline

    Self-reported use of smoker quitline services validated through objective review of the quitline database (whether participant contacted the quitline, whether a decision to start counseling was made, the type of counseling requested, the number of sessions received, whether a quit date was set, whether nicotine replacement products were requested by participants, and whether nicotine replacement products were sent to participants).

    7 months

  • Utilization of the National Cancer Institute "SmokefreeTXT" service

    Self-reported use of SmokefreeTXT validated through objective verification of program interaction (length of program utilization, and engagement with program).

    7 months

  • Utilization of clinic or hospital-based smoking cessation services

    Self-reported use of smoking cessation programs offered by clinics or hospitals (whether participant contacted the clinic, whether a decision to start counseling was made, the type of counseling requested, the number of sessions received, whether a quit date was set, whether nicotine replacement products and/or other cessation medications were requested by participants, and whether nicotine replacement products and/or other cessation medications were given to participants).

    7 months

Secondary Outcomes (7)

  • Use of a combination of EBTs

    7 months

  • Quit smoking attempts

    7 months

  • Motivation to quit smoking

    7 months

  • 7-day point prevalence smoking abstinence at end-of-treatment

    1 month

  • 7-day point prevalence smoking abstinence at end-of-treatment

    3 months

  • +2 more secondary outcomes

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 videoOther: Brochure of smoking cessation EBTsBehavioral: 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 videoOther: Brochure of smoking cessation EBTsOther: Assessment text messages

Interventions

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 videoBEHAVIORAL

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

Control group

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

Control groupIntervention group

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

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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. doi: 10.1186/s12903-026-07682-3. Online ahead of print.

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Belinda Borrelli, PhD

    Henry M Goldman School of Dental Medicine

    PRINCIPAL INVESTIGATOR

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

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Locations