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Tobacco Cessation Intervention Study for Oral Diseases (TISOD)

Primary Purpose

Smoking Cessation, Mouth Diseases, Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Tobacco cessation intervention
Sponsored by
Association for the Japanese Academy of Maxillofacial Implants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Keratosis, Implant, Lichen Planus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Okazaki City HospitalRecruiting
  • Shin Yurigaoka General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tobacco cessation intervention

Non-tobacco cessation intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pocket depth in peridontitis
Pocket depth and attachment loss with or without surgical treatment
Per-implant marginal bone loss
Per-implant marginal bone loss by a standardized X-ray photo
Size reduction of oral mucosal diseases
Size reduction (major x minor axis /mm) at a predominant site for non-surgical group

Secondary Outcome Measures

Tobacco abstinence rate
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)
The oral mucosa tissues are collected by buccal swab.

Full Information

First Posted
March 31, 2016
Last Updated
July 29, 2016
Sponsor
Association for the Japanese Academy of Maxillofacial Implants
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1. Study Identification

Unique Protocol Identification Number
NCT02737176
Brief Title
Tobacco Cessation Intervention Study for Oral Diseases
Acronym
TISOD
Official Title
Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association for the Japanese Academy of Maxillofacial Implants

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Lichen Planus, Keratosis, Implant
Keywords
Smoking Cessation, Mouth Diseases, Periodontal Diseases, Leukoplakia, Keratosis, Implant, Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
812 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tobacco cessation intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-tobacco cessation intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tobacco cessation intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pocket depth in peridontitis
Description
Pocket depth and attachment loss with or without surgical treatment
Time Frame
Change from baseline at 12 months
Title
Per-implant marginal bone loss
Description
Per-implant marginal bone loss by a standardized X-ray photo
Time Frame
Change from baseline at 12 months
Title
Size reduction of oral mucosal diseases
Description
Size reduction (major x minor axis /mm) at a predominant site for non-surgical group
Time Frame
Change from baseline at 12 months
Secondary Outcome Measure Information:
Title
Tobacco abstinence rate
Description
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™.
Time Frame
3,6,12 and 24 months
Title
HPV-DNA detection (p16 & 18)
Description
The oral mucosa tissues are collected by buccal swab.
Time Frame
pre- and post-treatment (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toru Nagao, PhD, DDS
Phone
+81-564-21-8111
Ext
7817
Email
tnagao@dpc.agu.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinichi Fukuda, PhD, DDS
Organizational Affiliation
Shin-Yurigaoka General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Okazaki City Hospital
City
Okazaki
State/Province
Aichi
ZIP/Postal Code
444-8553
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toru Nagao, PhD, DDS
Phone
+81-564-21-8111
Email
tnagao@dpc.agu.ac.jp
Facility Name
Shin Yurigaoka General Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
215-0026
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinichi Fukuda, DDS, PhD
Phone
+81-44-322-9991
Email
jinichi.fukuda@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33605440
Citation
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Results Reference
derived

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Tobacco Cessation Intervention Study for Oral Diseases

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