Tobacco Cessation Intervention Study for Oral Diseases (TISOD)

Association for the Japanese Academy of Maxillofacial Implants

Status: Unknown

Conditions: Leukoplakia; Keratosis; Lichen Planus; Mouth Diseases; Periodontal Diseases; Implant; Smoking Cessation

Treatments: Other: Tobacco cessation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02737176

AssociationJAMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 812 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

812 participants in 2 patient groups

Tobacco cessation intervention

Experimental group

Description:

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.

Treatment:

Other: Tobacco cessation intervention

Non-tobacco cessation intervention

No Intervention group

Description:

Those who do not intention to abstinence from smoking strongly and/or having less than 3 points in FTND test are allocated to non-tobacco cessation intervention group. The same treatment as the tobacco cessation intervention group is carried out for their oral diseases.