UMIN-CTR Clinical Trial

Public title

Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Acronym

Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Scientific Title

Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Scientific Title:Acronym

Randomized Clinical Trial for Prevention of Temporomandibular Disorders with Oral Appliance Therapy in Obstructive Sleep Apnea Syndrome

Region

Japan

Condition

Obstructive Sleep Apnea Syndrome

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Oral appliance (OA) therapy for patients with obstructive sleep apnea syndrome (OSAS) sometimes causes side effects such as temporomandibular disorders (TMD). Conventionally, for patients with TMD, mandibular exercise therapy has been given for the purpose of metabolic or flexibility improvement. In this study, we will reveal the effect on OA compliance and temporomandibular joint symptoms when using OA , by taking in advance mandibular exercise therapy for OSAS patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

We evaluate after two weeks, one month and three months of wearing OA.
Limitations of daily function (LDF-TMDQ), TMJ pain(VAS), The presence or absence of temporomandibular disorders by clinical examination, OA compliance

Key secondary outcomes

Subjective daytime sleepiness (JESS), Subjective sleep quality(PSQI), Oral health-related quality of life (OHIP-J), Health-related quality of life (SF-36)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Taking mandibular exercise about four weeks, before and after wearing OA

Interventions/Control_2

Taking placebo exercise about four weeks, before and after wearing OA

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

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients who have hope for oral appliance therapy
2. Patients who have more than 20 teeth (including the residual anterial teeth)
3. Patients from whom written informed consent is obtained in this study

Key exclusion criteria

1. AHI<5, or AHI>30 and BMI>30
2. Patients who have received OSAS treatment such as surgery or OA therapy previously
3. Patients who have chronic nasal congestion, a high degree of tonsillar hypertrophy
4. Patients who will be received combined OA and nCPAP therapy
5. The amount of mandible protrusion is less than 4mm
6. Patients who have received drug therapy related sleep, temporomandibular symptom (hypnotic, analgesic, anxiolytic)
7. Diagnosed as mental disorders
8. Patients who drink alcohol in most of day
9. Patients who diagnosed temporomandibular disorders by the RDC/TMD in preoperative examination (except only the clicking )
10. Patients who have suffered from pain in cervico-omo-section
11. Patients who need dental treatment for caries and periodontal disease in oral cavity

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Shusuke Inukai

Organization

Tokyo Medical and Dental University

Division name

Graduate school of Medical and Dental Sciences, Removable partial prosthodontics

Zip code

Address

1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8549, Japan

TEL

03-5803-5515

Email

shu.inukai.rpro@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Shusuke Inukai

Organization

Tokyo Medical and Dental University

Division name

Graduate school of Medical and Dental Sciences, Removable partial prosthodontics

Zip code

Address

1-5-45, Yushima, Bunkyo-Ku, Tokyo, 113-8549, Japan

TEL

03-5803-5515

Homepage URL

Email

shu.inukai.rpro@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Japan Society for the Promotion Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学歯学部附属病院（東京都）

Date of disclosure of the study information

2014

Year

05

Month

16

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

Completed

Date of protocol fixation

2014

Year

04

Month

25

Day

Date of IRB

Anticipated trial start date

2014

Year

06

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

05

Month

16

Day

Last modified on

2017

Year

07

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016272