UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025283 |
|---|---|
| Receipt number | R000028802 |
| Scientific Title | The effectiveness of implant-supported removable partial dentures in partially edentulous patients: A pilot study |
| Date of disclosure of the study information | 2016/12/19 |
| Last modified on | 2024/06/21 12:59:22 |
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Basic information
Public title
The effectiveness of implant-supported removable partial dentures in partially edentulous patients: A pilot study
Acronym
The effectiveness of implant-supported removable partial dentures in partially edentulous patients: A pilot study
Scientific Title
The effectiveness of implant-supported removable partial dentures in partially edentulous patients: A pilot study
Scientific Title:Acronym
The effectiveness of implant-supported removable partial dentures in partially edentulous patients: A pilot study
Region
| Japan |
Condition
Condition
Patients with mandibular unilateral free-end edentulism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of support by the dental implant for unilateral removable partial dentures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Masticatory performance (3 months after insertion of RPD, 3, 6 months, 1, 3, 5 years after fitting of RPD to an implant)
Key secondary outcomes
distribution of occlusal contact area, patient-reported outcome (3 months after insertion of RPD, 3, 6 months, 1, 3, 5 years after fitting of RPD to an implant)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Placement of a dental implant and insertion of an ISRPD (implant supported removable partial denture) , using ISRPD for over 5 years
Interventions/Control_2
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with the unilateral mandibular free end edentulism (Kennedy Classification II, missing from first premolar to second molar)
Key exclusion criteria
temporomandibular disorders, xerostomia, poor oral hygiene, serious systemic disease
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takayama |
Organization
Hokkaido University Hospital
Division name
Department of Removable Prosthodontics
Zip code
060-8648
Address
Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL
+81-11-706-4270
takayama@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takayama |
Organization
Hokkaido University Hospital
Division name
Department of Removable Prosthodontics
Zip code
060-8648
Address
Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL
+81-11-706-4270
Homepage URL
takayama@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Nippon Piston Ring Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Certified Review Board
Address
Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
Tel
011-706-7934
recjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028802
