UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of tobacco cessation for improving oral diseases - multicentre trial
Title of the study (Brief title)	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	Shinsaku Arai
Organization	Kyushu University Hospital
Division name	Department of Oral and Maxillofacial Surgery
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	Hitoshi Nagasu
Organization	Japanese Academy of Maxillofacial Implant
Division name	Secretariat
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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