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Efficacy of tobacco cessation for improving oral diseases - multicentre trial

Efficacy of tobacco cessation for improving oral diseases - multicentre trial - Multicentre trial for tobacco cessation of oral diseases

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024884
Enrollment
812
Registered
2016-11-18
Start date
2016-11-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Diseases

Interventions

Cessation intervention with or without NRT(nicitine replace therapy using nicitine patch or nicotine gum) for 12 weeks for those who intention to abstinence from smoking and having 3 points or more in

Sponsors

Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)
Lead Sponsor
Japanese Association for Dental Science
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Periodontitis patients who have 30% or more of the sites with 4 mm or more probing pocket depth and 3 sites or more with 6 mm or more probing depth Patients for implant treatment; about to implant placement for their tooth loss Oral mucosal diseases; having a pathological diagnosis and clinically diagnosed for nicotine stomatitis, oral leukoplakia, erythloplakia and oral lichen planus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Tobacco abstinence rate at each observation period at 3, 6, 12, 24 months for each disease group

Countries

Japan

Contacts

Public ContactHitoshi Nagasu

Japanese Academy of Maxillofacial Implant Secretariat

jamioffice@gmail.com03-3451-6916

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026