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Tobacco Cessation Intervention Study for Oral Diseases

NCT02737176 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 812

Last updated 2016-08-01

No results posted yet for this study

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.

Conditions

  • Smoking Cessation
  • Mouth Diseases
  • Periodontal Diseases
  • Leukoplakia
  • Lichen Planus
  • Keratosis
  • Implant

Interventions

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.

Sponsors & Collaborators

  • Association for the Japanese Academy of Maxillofacial Implants

    lead OTHER

Principal Investigators

  • Jinichi Fukuda, PhD, DDS · Shin-Yurigaoka General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737176 on ClinicalTrials.gov