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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3DE028866-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report 7-day Point Prevalence Smoking Abstinence | Participants self-report of no smoking, not even a puff, in the preceding 7 days. | 7 months |
| Verified 7-day Point Prevalence Smoking Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belinda Borrelli, PhD | Henry M Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry M Goldman School of Dental Medicine | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41526906 | Derived | 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. | |
| 35641925 | 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. |
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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.
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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)
Recruitment occurred using electronic dental records of dental patients at two university-affiliated dental clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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baseline characteristics of study participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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From enrollment until end of follow-up, up to 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Belinda Borrelli, PhD | Henry M. Goldman School of Dental Medicine | 617-358-3358 | belindab@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2024 | Mar 10, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2024 | Apr 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Research assistants who are collecting outcome data will be masked.
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| Control video | Behavioral | Participants randomized to the control group will watch a 10 minute video. |
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| Brochure of smoking cessation EBTs | Other | All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care. |
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| 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. |
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| 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. |
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| 7 months |
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).
| 7 months |
| 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. | 7 months |
| 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) | 7 months |
| 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. | within 10 days after the dental clinic visit. |
| 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. | up to 7 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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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.
| OG001 | 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. |
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| Primary | 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. | No data were available for 4 participants in the intervention group. | Posted | Count of Participants | Participants | 7 months |
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| Primary | 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). | At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Primary | 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). | At 1-month, 427 participants provided data. At 3-months, 406 participants provided data. At 6-months, 411 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Primary | 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). | At 1-month, 435 participants provided data. At 3-months, 416 participants provided data. At 6-months, 417 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | Self-report 7-day Point Prevalence Smoking Abstinence | Participants self-report of no smoking, not even a puff, in the preceding 7 days. | At 1-month, 425 participants provided data. At 3-months, 406 participants provided data. At 6-months, 407 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | 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). | At 1-month, 425 participants provided data. At 3-months, 406 participants provided data. At 6-months, 407 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | 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. | Includes only the subsample of participants who did not quit smoking (non-abstinent) during the study. Participants who quit smoking are not included. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | 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) | At 1-month, 426 participants provided data. At 3-months, 398 participants provided data. At 6-months, 404 participants provided data. | Posted | Count of Participants | Participants | 7 months |
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| Secondary | 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. | 428 participants provided data. | Posted | Mean | Standard Deviation | Score on a satisfaction questionnaire | within 10 days after the dental clinic visit. |
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| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | Scores on a treatment utilization scale | up to 7 months |
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| 0 |
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
| EG001 | 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. | 0 | 224 | 0 | 224 | 0 | 224 |
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| 3-months |
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| 6-months |
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| 1 EBT |
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| 2 EBTs |
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| 3 EBTs |
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| 4 EBTs |
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| 3-months |
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| 6-months |
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| 3-months |
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| 6-months |
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| 3-months |
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| 6-months |
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| 3-months |
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| 6-months |
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| 3-months |
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| 6-months |
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| 3-months |
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| 6-months |
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