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Efficacy of tobacco cessation for improving oral diseases - multicentre trial

Not Applicable
Conditions
Oral Diseases
Periodontitis Patients for implant treatment Oral mucosal diseases (nicotine stomatitis, oral leukoplakia, erythloplakia and oral lichen planus)
Registration Number
JPRN-UMIN000024884
Lead Sponsor
Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
812
Inclusion Criteria

Not provided

Exclusion Criteria

Less than 20 years old Already having any cessation intervention Having had periodontal treatment within 6 months Periodontitis patients who have anti-inflammatory drug or steroid use Patients for implant treatment; N/A Oral mucosal diseases; have had surgical resections before or other interventional treatments In case of use of nicotine replacement therapy (NRT);already have a prescription of NRTs or medicines, pregnant and breastfeeding women, has unstable angina pectoris, in the immediate (within 3 months) past myocardial infarction period, have serious arrhythmias, post-percutaneous coronary intervention (PCI), post-coronary artery bypass graft (CABG), early period of recovery from cerebrovascular disease

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical improvement of each disease (12 months after the treatment) Periodontitis- Probing pocket depth and clinical attachment level of two sites with the deepest periodontal pocket (6 mm or more) Implant- one-year implant survival and per-implant marginal bone loss the day after implant placement and after 1 year measured by a standardized X-ray photo Oral mucosal diseases-size reduction (major x minor axis /mm) at a predominant site for non-surgical group and recurrence rate for surgical group
Secondary Outcome Measures
NameTimeMethod
Tobacco abstinence rate at each observation period at 3, 6, 12, 24 months for each disease group
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