An interventional study of Tobacco cessation intervention in Smoking Cessation, Mouth Diseases and Periodontal Diseases, sponsored by Association for the Japanese Academy of Maxillofacial Implants. Status unknown at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-08-01.
Sponsored by Association for the Japanese Academy of Maxillofacial Implants · Not applicable, Interventional, and Treatment
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.
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.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 812 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →This is the only study on the registry with Association for the Japanese Academy of Maxillofacial Implants as lead sponsor.
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Criteria
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Tobacco cessation intervention
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.
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.
Pocket depth in peridontitis
Pocket depth and attachment loss with or without surgical treatment
Time frame: Change from baseline at 12 months
Per-implant marginal bone loss
Per-implant marginal bone loss by a standardized X-ray photo
Time frame: Change from baseline at 12 months
Size reduction of oral mucosal diseases
Size reduction (major x minor axis /mm) at a predominant site for non-surgical group
Time frame: Change from baseline at 12 months
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™.
Time frame: 3,6,12 and 24 months
HPV-DNA detection (p16 & 18)
The oral mucosa tissues are collected by buccal swab.
Time frame: pre- and post-treatment (12 months)
Plan to share: No
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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