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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025283
Receipt No. 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 2018/02/02

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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
Middle name
Last name Takayama, Yoshiyuki
Organization Hokkaido University Hospital
Division name Department of Removable Prosthodontics
Zip code
Address Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL +81-11-706-4270
Email takayama@den.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayama, Yoshiyuki
Organization Hokkaido University Hospital
Division name Department of Removable Prosthodontics
Zip code
Address Nishi-5, Kita-14, Kita-Ku, Sapporo, Japan
TEL +81-11-706-4270
Homepage URL
Email takayama@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Address
Tel
Email

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 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
2024 Year 09 Month 30 Day
Date trial data considered complete
2024 Year 12 Month 31 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2018 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028802

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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