Tobacco Cessation Intervention Study for Oral Diseases (TISOD)
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|ClinicalTrials.gov Identifier: NCT02737176|
Recruitment Status : Unknown
Verified July 2016 by Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants.
Recruitment status was: Recruiting
First Posted : April 13, 2016
Last Update Posted : August 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Mouth Diseases Periodontal Diseases Leukoplakia Lichen Planus Keratosis Implant||Other: Tobacco cessation intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||812 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Tobacco cessation intervention
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
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.
No Intervention: Non-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.
- Pocket depth in peridontitis [ Time Frame: Change from baseline at 12 months ]Pocket depth and attachment loss with or without surgical treatment
- Per-implant marginal bone loss [ Time Frame: Change from baseline at 12 months ]Per-implant marginal bone loss by a standardized X-ray photo
- Size reduction of oral mucosal diseases [ Time Frame: Change from baseline at 12 months ]Size reduction (major x minor axis /mm) at a predominant site for non-surgical group
- Tobacco abstinence rate [ Time Frame: 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) [ Time Frame: pre- and post-treatment (12 months) ]The oral mucosa tissues are collected by buccal swab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737176
|Contact: Toru Nagao, PhD, DDS||+81-564-21-8111 ext firstname.lastname@example.org|
|Okazaki City Hospital||Recruiting|
|Okazaki, Aichi, Japan, 444-8553|
|Contact: Toru Nagao, PhD, DDS +81-564-21-8111 email@example.com|
|Shin Yurigaoka General Hospital||Recruiting|
|Kawasaki, Kanagawa, Japan, 215-0026|
|Contact: Jinichi Fukuda, DDS, PhD +81-44-322-9991 firstname.lastname@example.org|
|Study Chair:||Jinichi Fukuda, PhD, DDS||Shin-Yurigaoka General Hospital|