UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)

Institute

Department

Personal name

Organization

Japanese Academy of Maxillofacial Implant

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Japanese Association for Dental Science

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2016

Year

11

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

17

Day

Last modified on

2016

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028635