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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02737176 |
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Date of registration:
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31/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tobacco Cessation Intervention Study for Oral Diseases
TISOD |
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Scientific title:
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Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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812 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02737176 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toru Nagao, PhD, DDS |
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Address:
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Telephone:
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+81-564-21-8111 |
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Email:
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tnagao@dpc.agu.ac.jp |
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Affiliation:
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Name:
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Jinichi Fukuda, PhD, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shin-Yurigaoka General Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Smoking Cessation
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Implant
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Mouth Diseases
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Lichen Planus
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Periodontal Diseases
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Keratosis
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Leukoplakia
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Intervention(s)
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Other: Tobacco cessation intervention
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Primary Outcome(s)
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Per-implant marginal bone loss
[Time Frame: Change from baseline at 12 months]
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Pocket depth in peridontitis
[Time Frame: Change from baseline at 12 months]
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Size reduction of oral mucosal diseases
[Time Frame: Change from baseline at 12 months]
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Secondary Outcome(s)
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Tobacco abstinence rate
[Time Frame: 3,6,12 and 24 months]
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HPV-DNA detection (p16 & 18)
[Time Frame: pre- and post-treatment (12 months)]
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Secondary ID(s)
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AssociationJAMI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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