UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021429 |
|---|---|
| Receipt number | 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 10:21:29 |
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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
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
jamioffice@gmail.com
Sponsor or person
Institute
Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022980
