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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

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Mouth Diseases Periodontal Diseases Leukoplakia Lichen Planus Keratosis Implant Other: Tobacco cessation intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 812 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
Study Start Date : April 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mouth Disorders

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.



Primary Outcome Measures :
  1. Pocket depth in peridontitis [ Time Frame: Change from baseline at 12 months ]
    Pocket depth and attachment loss with or without surgical treatment

  2. Per-implant marginal bone loss [ Time Frame: Change from baseline at 12 months ]
    Per-implant marginal bone loss by a standardized X-ray photo

  3. 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


Secondary Outcome Measures :
  1. 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™.

  2. HPV-DNA detection (p16 & 18) [ Time Frame: pre- and post-treatment (12 months) ]
    The oral mucosa tissues are collected by buccal swab.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737176


Contacts
Contact: Toru Nagao, PhD, DDS +81-564-21-8111 ext 7817 tnagao@dpc.agu.ac.jp

Locations
Japan
Okazaki City Hospital Recruiting
Okazaki, Aichi, Japan, 444-8553
Contact: Toru Nagao, PhD, DDS    +81-564-21-8111    tnagao@dpc.agu.ac.jp   
Shin Yurigaoka General Hospital Recruiting
Kawasaki, Kanagawa, Japan, 215-0026
Contact: Jinichi Fukuda, DDS, PhD    +81-44-322-9991    jinichi.fukuda@gmail.com   
Sponsors and Collaborators
Association for the Japanese Academy of Maxillofacial Implants
Investigators
Study Chair: Jinichi Fukuda, PhD, DDS Shin-Yurigaoka General Hospital

Responsible Party: Toru Nagao, PhD, DMSc, DDS, Director, Association for the Japanese Academy of Maxillofacial Implants
ClinicalTrials.gov Identifier: NCT02737176     History of Changes
Other Study ID Numbers: AssociationJAMI
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Toru Nagao, PhD, DMSc, DDS, Association for the Japanese Academy of Maxillofacial Implants:
Smoking Cessation
Mouth Diseases
Periodontal Diseases
Leukoplakia
Keratosis
Implant
Lichen Planus

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Periodontal Diseases
Gingival Diseases
Lichen Planus
Mouth Diseases
Leukoplakia
Skin Diseases
Precancerous Conditions
Neoplasms
Stomatognathic Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Pathological Conditions, Anatomical
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action