Tobacco Cessation Intervention Study for Oral Diseases

Not Applicable

• Conditions: Smoking Cessation; Implant; Leukoplakia; Mouth Diseases; Keratosis; Periodontal Diseases; Lichen Planus
• Interventions: Other: Tobacco cessation intervention

• Registration Number: NCT02737176
• Lead Sponsor: Association for the Japanese Academy of Maxillofacial Implants

Brief Summary

This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.

Detailed Description

It has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (Cochrane Database Syst Rev.6:CD005084.) However, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. There are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. Association for the Japanese Academy of Maxillofacial Implants, Association for the Japanese Society of Oral and Maxillofacial Surgeons, Association for the Japanese Society of Oral Implantology, Japanese Society of Oral Medicine, Japanese Society of Periodontology, Japanese Academy of Clinical Periodontology, Japanese Society for Oral Health, Japanese Society of Dentistry for Medically Compromised Patient and Japanese Society of Oral Oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.

Study Timeline

• Study First Submitted: 2016-03-31
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-13
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 812

Inclusion Criteria

• Current smokers with periodontitis; 30% or more of the teeth where periodontal pocket depth (PPD) is 4mm or more and 3 or more sites in 6mm or more of the PPD
• Current smokers in patients about to receive implant placement
• Current smokers with oral mucosal diseases clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythroplakia and oral lichen planus

Exclusion Criteria

• Already having any cessation intervention
• Periodontitis with having anti-inflammatory drug or steroid use and have had periodontal treatment within 6 months
• Oral mucosal diseases having had surgical resections or other interventional treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobacco cessation intervention	Tobacco cessation intervention	Tobacco cessation intervention is implemented for 12 weeks. The nicotine dependence status is evaluated by the FTND (Fagerstrom Test for Nicotine Dependence) test. The point 3 or more is regarded as a moderate or high tobacco dependence and determining a cessation intervention. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Even if participants fail to abstain from smoking, the oral treatment is continued. In case of the use of the NRTs (nicotine patch and/or gum), the investigators supply it for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy.

Primary Outcome Measures

Name	Time	Method
Pocket depth in peridontitis	Change from baseline at 12 months	Pocket depth and attachment loss with or without surgical treatment
Per-implant marginal bone loss	Change from baseline at 12 months	Per-implant marginal bone loss by a standardized X-ray photo
Size reduction of oral mucosal diseases	Change from baseline at 12 months	Size reduction (major x minor axis /mm) at a predominant site for non-surgical group

Secondary Outcome Measures

Name	Time	Method
Tobacco abstinence rate	3,6,12 and 24 months	Biochemical validation tests confirming for quit smoking is applied for all subjects. Measurements of expired carbon monoxide (CO) where the test is available are analyzed at each period. Otherwise cotinine levels of the saliva samples are analyzed by a semi-quantitative analysis by NicAlert™.
HPV-DNA detection (p16 & 18)	pre- and post-treatment (12 months)	The oral mucosa tissues are collected by buccal swab.

Trial Locations

Locations (2)

Okazaki City Hospital; 🇯🇵 Okazaki, Aichi, Japan

Shin Yurigaoka General Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan