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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021429
Receipt No. R000022980
Scientific Title Efficacy of tobacco cessation for improving oral diseases - multicentre trial
Date of disclosure of the study information 2016/04/01
Last modified on 2020/07/26

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Basic information
Public title Efficacy of tobacco cessation for improving oral diseases - multicentre trial
Acronym Multicentre trial for tobacco cessation of oral diseases
Scientific Title Efficacy of tobacco cessation for improving oral diseases - multicentre trial
Scientific Title:Acronym Multicentre trial for tobacco cessation of oral diseases
Region
Japan

Condition
Condition Oral Diseases;
Periodontitis
Patients for implant treatment
Oral mucosal diseases (nicotine stomatitis, oral leukoplakia, erythloplakia and oral lichen planus)
Classification by specialty
Oral surgery Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy of tobacco cessation intervention for oral diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes Tobacco abstinence rate at each observation period at 3, 6, 12, 24 months for each disease group

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 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 FTND (Fagerstrom Test for Nicotine Dependence) test
Interventions/Control_2 Non tobacco cessation intervention for those who do not intention to abstinence from smoking strongly and having less than 3 points in FTND (Fagerstrom Test for Nicotine Dependence) test
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 812

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Nagao
Organization School of Dentistry, Aichi Gakuin University
Division name Department of Maxillofacial Surgery
Zip code 464-8651
Address 2-11, Suemori-dori, Chikusa-ku, 464-8651,Aichi, Japan
TEL 052-751-7181
Email tnagao@dpc.agu.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Nagasu
Organization Japanese Academy of Maxillofacial Implant
Division name Secretariat
Zip code 108-0014
Address 5-29-22-805,Shiba, Minato-ku, Tokyo,108-0014, Japan
TEL 03-3451-6916
Homepage URL http://www.jamfi.net/tisod///index.html
Email jamioffice@gmail.com

Sponsor
Institute Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japanese Association for Dental Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of the Japanese Society of Oral and Maxillofacial Surgeons
Address 2-20-26-202 Takanawa, Minato-ku, Tokyo 108-0074
Tel 03-5791-1791
Email office@jsoms.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02737176
Org. issuing International ID_1 ClinicalTrials. Gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛知学院大学歯学部顎顔面外科学講座(代表)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.jads.jp/jjads_j/jjads_j_37.pdf
Number of participants that the trial has enrolled 74
Results
74 dental patients for enrolment in the trial. The self-reported tobacco abstinence rate in the intervention group was 62.3% at month 3, 42.6% at month 6, and 41.0% at month 12; however, the respective biochemically confirmed abstinence rates were 37.7%, 34.4%, and 32.8%. The patients receiving implant treatment achieved the highest rate of biochemically confirmed tobacco cessation at 42.9% at month 12, followed by 37.1% in those with OPMD and 21.1% in those with periodontitis. 
Results date posted
2020 Year 06 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Tobacco Abstinence Rate
Size Reduction rate of Oral Potentially Malignant Disorder (OPMD)
Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) and Bleeding on Probing (BOP) in Peridontitis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
2015 Year 06 Month 25 Day
Anticipated trial start date
2016 Year 04 Month 12 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 10 Day
Last modified on
2020 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022980

Research Plan
Registered date File name
2018/09/10 kenkyukeikakusyo2.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/06/11 TISOD data set (n=74).xlsx


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