UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053953 |
|---|---|
| Receipt number | R000060657 |
| Scientific Title | Effect of rigid-connected removable partial denture placement on protection of mobile abutment teeth: a randomized controlled trial |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2025/09/24 08:50:15 |
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Basic information
Public title
Effect of rigid-connected removable partial denture placement on protection of mobile abutment teeth: a randomized controlled trial
Acronym
Effect of rigid-connected RPD on mobile tooth protection
Scientific Title
Effect of rigid-connected removable partial denture placement on protection of mobile abutment teeth: a randomized controlled trial
Scientific Title:Acronym
Effect of rigid-connected RPD on mobile tooth protection
Region
| Japan |
Condition
Condition
partially edentulous dental arch
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the removable partial denture design concept to protect denture abutment teeth with hypermobility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mobility of denture abutment teeth
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stress-breaking denture design
Interventions/Control_2
Rigid connection denture design without any hinges
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
Diagnosis of periodontitis at the first visit
Undergoing supportive periodontal therapy (SPT)
Reduction of occlusal supports (Eichner classification from B2 to C1)
Kennedy Class I partially edentulous dental arch
Hypermobility of denture abutment tooth (more than 10 of Periotest value)
Key exclusion criteria
Acute dental and periodontal disease
All denture abutment teeth are connected to other teeth with fixed prostheses
Attachment loss of denture abutment teeth more than 50%
Definite furcation involvement (grade II-IV)
Using a night guard
Severe sleep bruxism
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of advanced prosthodontics
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035515
wadajun.rpro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University (TMDU)
Division name
Department of advanced prosthodontics
Zip code
1138510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035515
Homepage URL
wadajun.rpro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University (TMDU)
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University (TMDU)
Address
1-5-45, Yushima, Bunkyo-ku,
Tel
0358035515
info.bec@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 25 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060657
