A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study.

BACKGROUND: Cigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings. METHODS: This manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke-regardless of interest in quitting- are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS. DISCUSSION: This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke. TRIAL REGISTRATION: Registered at ClincalTrials.gov (NCT05627596) on 11/25/2022.

Oral health-related quality of life among an Australian sample of people who inject drugs.

OBJECTIVES: People who inject drugs (PWID) have poor oral health. However, their oral health-related quality of life (OHRQoL) is unknown. Our study was designed to measure the OHRQoL of PWID. METHODS: The Oral Health Impact Profile-14 (OHIP-14) was administered to 794 PWID recruited in Australian capital cities as part of the 2013 Illicit Drug Reporting System (IDRS). Three OHIP-14 summary indicators were examined: "Prevalence" (proportion reporting ≥1 item at least "fairly often"), "severity" (mean total OHIP-14 score), and "extent" (number of impacts reported at least "fairly often"). Associations between "prevalence" and "extent" and variables drawn from the health, drug use, and social domains were investigated. RESULTS: All OHIP-14 summary indicators among IDRS participants were significantly higher than in the general Australian population. In multivariate analysis, the "prevalence" indicator was significantly and positively associated with female gender [adjusted odds ratio (AOR) = 1.75, 95% CI 1.27-2.38], those born in Australia (AOR = 2, 95% CI 1.25-3.23), not completing Year 10 compared with those who had completed Year 12 or a higher qualification (AOR = 1.59, 95% CI 1.03-2.44), and methadone treatment (AOR = 1.61, 95% CI 1.14-2.29). The "extent" indicator was significantly and positively associated with female gender [adjusted incidence rate ratio (AIRR) = 1.56, 95% CI 1.19-2.08], unemployment (AIRR = 1.59, 95% CI 1.01-2.44), and having an injecting career of 10-20 years (AIRR = 1.76, 95% CI 1.03-3.01). CONCLUSIONS: PWID have poorer OHRQoL than the Australian general population. Poor OHRQoL was particularly common in female PWID and those with longer injecting careers. Interventions to improve the oral health of PWID may improve their OHRQoL.