Clinical trial NCT02737176: Tobacco Cessation Intervention Study for Oral Diseases
Official title: Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Mouth Diseases
Periodontal Diseases
Leukoplakia
Lichen Planus
Keratosis
Implant
Keywords: Smoking Cessation
Mouth Diseases
Periodontal Diseases
Leukoplakia
Keratosis
Implant
Lichen Planus
Lead sponsor: Association for the Japanese Academy of Maxillofacial Implants
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 812
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Criteria

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

Primary outcomes:
measure: Pocket depth in peridontitis
timeFrame: Change from baseline at 12 months
measure: Per-implant marginal bone loss
timeFrame: Change from baseline at 12 months
measure: Size reduction of oral mucosal diseases
timeFrame: Change from baseline at 12 months
Secondary outcomes:
measure: Tobacco abstinence rate
timeFrame: 3,6,12 and 24 months
measure: HPV-DNA detection (p16 & 18)
timeFrame: pre- and post-treatment (12 months)
Other outcomes:
Locations:
city: Okazaki
country: Japan
facility: Okazaki City Hospital
state: Aichi
city: Kawasaki
country: Japan
facility: Shin Yurigaoka General Hospital
state: Kanagawa
Study officials:
affiliation: Shin-Yurigaoka General Hospital
name: Jinichi Fukuda, PhD, DDS
role: STUDY_CHAIR
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.