Tobacco Cessation Intervention Study for Oral Diseases (TISOD)

July 29, 2016 updated by: Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants

Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Aichi
      • Okazaki, Aichi, Japan, 444-8553
        • Recruiting
        • Okazaki City Hospital
        • Contact:
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 215-0026
        • Recruiting
        • Shin Yurigaoka General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pocket depth in peridontitis
Time Frame: Change from baseline at 12 months
Pocket depth and attachment loss with or without surgical treatment
Change from baseline at 12 months
Per-implant marginal bone loss
Time Frame: Change from baseline at 12 months
Per-implant marginal bone loss by a standardized X-ray photo
Change from baseline at 12 months
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
Change from baseline at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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™.
3,6,12 and 24 months
HPV-DNA detection (p16 & 18)
Time Frame: pre- and post-treatment (12 months)
The oral mucosa tissues are collected by buccal swab.
pre- and post-treatment (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for the Japanese Academy of Maxillofacial Implants

Investigators

  • Study Chair: Jinichi Fukuda, PhD, DDS, Shin-yurigaoka General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssociationJAMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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