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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018586
Receipt No. R000021512
Scientific Title Randomized controlled trial on efficacy of non-metal clasp dentures
Date of disclosure of the study information 2015/09/01
Last modified on 2019/08/13

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Basic information
Public title Randomized controlled trial on efficacy of non-metal clasp dentures
Acronym Randomized controlled trial of non-metal clasp dentures
Scientific Title Randomized controlled trial on efficacy of non-metal clasp dentures
Scientific Title:Acronym Randomized controlled trial of non-metal clasp dentures
Region
Japan

Condition
Condition Missing teeth
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify efficacy of non-metal clasp dentures
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oral Health-related Quality of Life

Questionnaire: Oral-health impact profile (OHIP)-J (54 items)
Evaluation interval: pre-treatment,
3, 6, 12, 24 and 36 month after treatment
Key secondary outcomes Patient satisfaction
Masticatory function
Periodontal condition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Metal clasp denture
Interventions/Control_2 Non-metal clasp denture
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 - Patients who are planned to receive prosthetic treatment with definitive clasp-retained removable partial dentures
- Clasps will be fabricated on anterior and/or premolar teeth
- Absence of caries on all abutment teeth
- Mobility less than 2, periodontal pocket depth less than 4 mm and absence of bleeding on probing on all abutment teeth
Key exclusion criteria - Contra-indications for non-metal clasp dentures
-Metal full cast fixed denture is fabricated on abutment on which resin clasp will be placed
- Patients who cannot accept to use metal clasp dentures due to esthetic reason
- Patients with metal, accrylic resin, peanuts allergy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Fueki
Organization Tokyo Medical and Dental University
Division name Graduate school, Removable partial denture prosthodontics
Zip code 1130034
Address 1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL 03-5803-5514
Email kunfu.rpro@tmd.ac.jp

Public contact
Name of contact person
1st name Fueki
Middle name
Last name Kenji
Organization Tokyo Medical and Dental University
Division name Graduate school, Removable partial denture prosthodontics
Zip code 1130034
Address 1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
TEL 03-5803-5744
Homepage URL
Email kunfu.rpro@tmd.ac.jp

Sponsor
Institute Kenji Fueki
Institute
Department

Funding Source
Organization Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45, Yushima 1-chome, Bunkyo-Ku, Tokyo, 113-8549, Japan
Tel 03-5803-5404
Email d-hyoka.adm@tmd.ac.jp

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 東京医科歯科大学歯学部附属病院(東京都)Tokyo Medical and dental University Hospital Faculty of Dentistry

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 08 Month 31 Day
Date of IRB
2015 Year 08 Month 07 Day
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 07 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021512

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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