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Recruitment status
Unique ID issued by UMIN UMIN000024884
Receipt No. R000028635
Scientific Title Efficacy of tobacco cessation for improving oral diseases - multicentre trial
Date of disclosure of the study information 2016/11/18
Last modified on 2016/11/17

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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
Middle name
Last name Shinsaku Arai
Organization Kyushu University Hospital
Division name Department of Oral and Maxillofacial Surgery
Zip code
Address 3-1-1, Maidaishi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-6447
Email aratube@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Nagasu
Organization Japanese Academy of Maxillofacial Implant
Division name Secretariat
Zip code
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 Japanese Academy of Maxillofacial Implant
Organization
Division
Category of Funding Organization Other
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 18 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 17 Day
Last modified on
2016 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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