Suspended

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

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What is being tested

Tobacco cessation intervention

Other
Who is being recruted

Behavior+14

+ Keratosis

+ Leukoplakia

Over 20 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2016
See protocol details

Summary

Principal SponsorAssociation for the Japanese Academy of Maxillofacial Implants
Study ContactToru Nagao, PhD, DDS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
NCT02737176
Principal SponsorAssociation for the Japanese Academy of Maxillofacial Implants
Study ContactToru Nagao, PhD, DDS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

812 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorKeratosisLeukoplakiaLichen PlanusStomatognathic DiseasesMouth DiseasesNeoplasmsPeriodontal DiseasesPrecancerous ConditionsSkin DiseasesPathological Conditions, Signs and SymptomsHealth BehaviorSmoking CessationSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousLichenoid EruptionsPathological Conditions, Anatomical

Criteria

3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Okazaki City Hospital

Okazaki, JapanOpen Okazaki City Hospital in Google Maps
Recruiting

Shin Yurigaoka General Hospital

Kawasaki, Japan
Suspended2 Study Centers