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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
Sponsor:
Information provided by (Responsible Party):
Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date August 1, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02737176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tobacco Cessation Intervention Study for Oral Diseases
Official Title  ICMJE Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Mouth Diseases
  • Periodontal Diseases
  • Leukoplakia
  • Lichen Planus
  • Keratosis
  • Implant
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Tobacco cessation intervention
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 8, 2016)
812
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737176
Other Study ID Numbers  ICMJE AssociationJAMI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants
Study Sponsor  ICMJE Association for the Japanese Academy of Maxillofacial Implants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jinichi Fukuda, PhD, DDS Shin-Yurigaoka General Hospital
PRS Account Association for the Japanese Academy of Maxillofacial Implants
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP