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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033316
Receipt No. R000037978
Official scientific title of the study Influence of using oral appliances during sleep on conditions of remaining teeth and residual ridges in removable partial denture wearers
Date of disclosure of the study information 2018/07/07
Last modified on 2018/07/07

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Basic information
Official scientific title of the study Influence of using oral appliances during sleep on conditions of remaining teeth and residual ridges in removable partial denture wearers
Title of the study (Brief title) Influence of OA on sleep bruxism in RPD wearers
Region
Japan

Condition
Condition partially edentulous dental arch
sleep bruxism
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of using oral appliances (night dentures) during sleep on the conditionds of remaining teeth (including periodontal tissues) and residual ridges in partial removable denture wearers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tooth mobility
Key secondary outcomes clinical periodontal examination
tooth attrition
residual ridge condition
quality of sleeping
radiographic examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 wearing oral appliances (night denture) duaring sleep at night
Interventions/Control_2 wearing no oral appliances duaring sleep at night
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 diagnosed with sleep bruxism
wearring removable partial denture
classified as B-2 to B-4 with Eichner's classification
Key exclusion criteria Acute symptoms of oral and craniofacial diseases
Currently under periodontal treatment(except supportive periodontal therapy)
Current use of an oral appliance during sleep
Having an abutment tooth conected with next tooth with fixed prosthesis
Contraction of infectious disease or systemic disease(leukemia, HIV, etc.)
Target sample size 70

Research contact person
Name of lead principal investigator Junichiro Wada
Organization Division of Oral Health Sciences,
Track of Medical and Dental Sciences,
Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University (TMDU)
Division name Department of Removable Partial Prosthodontics
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL 03-5803-4947
Email wadajun.rpro@tmd.ac.jp

Public contact
Name of contact person Junichiro Wada
Organization Tokyo Medical and Dental University (TMDU)
Division name Department of Removable Partial Prosthodontics
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan
TEL 03-5803-4947
Homepage URL
Email wadajun.rpro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University (TMDU)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 05 Day
Anticipated trial start date
2018 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 07 Month 07 Day
Last modified on
2018 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037978

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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