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	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

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

Institute

Tobacco Cessation Intervention Study Team for Oral Diseases (TISOD)

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Japanese Association for Dental Science

Name of secondary funder(s)

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

YES

Study ID_1

NCT02737176

Org. issuing International ID_1

ClinicalTrials. Gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛知学院大学歯学部顎顔面外科学講座（代表）

Date of disclosure of the study information

2016

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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