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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT02737176
Date of registration: 31/03/2016
Prospective Registration: Yes
Primary sponsor: Association for the Japanese Academy of Maxillofacial Implants
Public title: Tobacco Cessation Intervention Study for Oral Diseases TISOD
Scientific title: Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
Date of first enrolment: April 2016
Target sample size: 812
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02737176
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Japan
Contacts
Name:     Toru Nagao, PhD, DDS
Address: 
Telephone: +81-***********
Email: tnagao@dpc.agu.ac.jp
Affiliation: 
Name:     Jinichi Fukuda, PhD, DDS
Address: 
Telephone:
Email:
Affiliation:  Shin-Yurigaoka General Hospital
Key inclusion & 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



Age minimum: 20 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Implant
Keratosis
Leukoplakia
Lichen Planus
Mouth Diseases
Periodontal Diseases
Smoking Cessation
Intervention(s)
Other: Tobacco cessation intervention
Primary Outcome(s)
Per-implant marginal bone loss [Time Frame: Change from baseline at 12 months]
Pocket depth in peridontitis [Time Frame: Change from baseline at 12 months]
Size reduction of oral mucosal diseases [Time Frame: Change from baseline at 12 months]
Secondary Outcome(s)
HPV-DNA detection (p16 & 18) [Time Frame: pre- and post-treatment (12 months)]
Tobacco abstinence rate [Time Frame: 3,6,12 and 24 months]
Secondary ID(s)
AssociationJAMI
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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