Tobacco Cessation Intervention Study for Oral Diseases

Smoking Cessation Clinical Trial

— TISOD  

Official title:

Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02737176
• Other study ID #: AssociationJAMI
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2016
• Last updated: July 29, 2016
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Association for the Japanese Academy of Maxillofacial Implants
• Contact: Toru Nagao, PhD, DDS
• Phone: +81-564-21-8111
• Email: tnagao[@]dpc.agu.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 812
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Implant
• Keratosis
• Keratosis, Actinic
• Leukoplakia
• Lichen Planus
• Mouth Diseases
• Periodontal Diseases
• Smoking Cessation

Intervention

Other:
• Tobacco cessation intervention
The nicotine dependence status is evaluated by the Fagerstrom Test for Nicotine Dependence test; those who 3 or more score are eligible for the intervention. During the study, attending doctors implement a tobacco cessation intervention with standard treatments for above oral diseases. Even if the subjects failed to abstain from smoking, the treatment is continued. In case of the use of the nicotine replacement therapy, The investigators supply NRTs (nicotine patch or gum) for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy.

Locations

Country	Name	City	State
Japan	Shin Yurigaoka General Hospital	Kawasaki	Kanagawa
Japan	Okazaki City Hospital	Okazaki	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Association for the Japanese Academy of Maxillofacial Implants

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket depth in peridontitis	Pocket depth and attachment loss with or without surgical treatment	Change from baseline at 12 months	No
Primary	Per-implant marginal bone loss	Per-implant marginal bone loss by a standardized X-ray photo	Change from baseline at 12 months	No
Primary	Size reduction of oral mucosal diseases	Size reduction (major x minor axis /mm) at a predominant site for non-surgical group	Change from baseline at 12 months	No
Secondary	Tobacco abstinence rate	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™.	3,6,12 and 24 months	No
Secondary	HPV-DNA detection (p16 & 18)	The oral mucosa tissues are collected by buccal swab.	pre- and post-treatment (12 months)	No