Tobacco Cessation Intervention Study for Oral Diseases
TISOD
Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
1 other identifier
interventional
812
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 1, 2016
July 1, 2016
1.7 years
March 31, 2016
July 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pocket depth in peridontitis
Pocket depth and attachment loss with or without surgical treatment
Change from baseline at 12 months
Per-implant marginal bone loss
Per-implant marginal bone loss by a standardized X-ray photo
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
Change from baseline at 12 months
Secondary Outcomes (2)
Tobacco abstinence rate
3,6,12 and 24 months
HPV-DNA detection (p16 & 18)
pre- and post-treatment (12 months)
Study Arms (2)
Tobacco cessation intervention
EXPERIMENTALTobacco 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.
Non-tobacco cessation intervention
NO INTERVENTIONThose 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Okazaki City Hospital
Okazaki, Aichi-ken, 444-8553, Japan
Shin Yurigaoka General Hospital
Kawasaki, Kanagawa, 215-0026, Japan
Related Publications (1)
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
PMID: 33605440DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jinichi Fukuda, PhD, DDS
Shin-Yurigaoka General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 31, 2016
First Posted
April 13, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
August 1, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share