Implant, Keratosis, Leukoplakia, Lichen Planus, Mouth Diseases, Periodontal Diseases, Smoking Cessation
Conditions
Keywords
Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Keratosis, Implant, Lichen Planus
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.
Interventions
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.
Sponsors
Association for the Japanese Academy of Maxillofacial Implants
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Contacts
Primary ContactToru Nagao, PhD, DDS
Outcome results
None listed