N/A N=718 Randomized Single-blind Treatment

Promoting Oral Health Among Smokers Randomized Trial

Oral Disease · Smoking

Bottom Line

View on ClinicalTrials.gov: NCT02347124 ↗

Enrolled (actual)

718

Serious AEs

0.4%

Results posted

May 2018

Primary outcome: Primary: 7 Day Point Prevalent Abstinence (PPA) — 109; 121 Participants — p=0.13

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Usual Care Control (Behavioral); Enhanced Intervention (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY 7 Day Point Prevalent Abstinence (PPA)	116; 127	0.21
PRIMARY Professional Dental Care Utilization in Past 6 Months	67; 65	0.90
SECONDARY 7 Day Point Prevalent Abstinence (PPA)	116; 127	0.21
SECONDARY 7 Day Point Prevalent Smoking Abstinence (PPA)	109; 121	0.09
SECONDARY 7 Day Point Prevalent Smoking Abstinence (PPA)	109; 121	0.09

Summary

The current study will test the effectiveness of a multi-modal behavioral intervention (the Oral Health 4 Life program) targeted to smokers who are ready to quit smoking and seeking services through tobacco quitlines. The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will: 1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up [primary outcome] and at 2 month follow-up [secondary outcome]. 2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome]. 3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Eligibility Criteria

Inclusion criteria

Male or female, aged 18 or older
Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing
Can read and speak in English
Current daily smoker and smokes at least 5 cigarettes a day
Interested in quitting smoking in next 30 days
Have some or all natural teeth
Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months
Has a cell phone capable of receiving text messages and provides cell phone number
Has internet access for personal use
Willing to talk about ways to improve their oral health
Provides verbal consent to participate

Exclusion criteria

Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment)
Have lived at the current address less than 6 months or plans to move in the next 6 months
Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated
Has a household member already enrolled in the study, based on self-report and/or mailing address on file

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02347124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.