UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017883 |
|---|---|
| Receipt number | R000019591 |
| Scientific Title | Randomized crossover trial of mandibular single-implant overdenture: patient-reported outcome and cost-effectiveness |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2023/07/20 12:15:44 |
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Basic information
Public title
Randomized crossover trial of mandibular single-implant overdenture: patient-reported outcome and cost-effectiveness
Acronym
Randomized crossover trial of mandibular single-implant overdenture
Scientific Title
Randomized crossover trial of mandibular single-implant overdenture: patient-reported outcome and cost-effectiveness
Scientific Title:Acronym
Randomized crossover trial of mandibular single-implant overdenture
Region
| Japan |
Condition
Condition
Completely mandibular edentulous arch
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare between the cost-effectiveness of mandibular single-implant overdentures and that of complete dentures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cost-effectiveness
Key secondary outcomes
Patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Single implant overdenture(2 months)
Interventions/Control_2
Complete denture(2 months)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
completely mandibular edentulous arch.
Having sufficient volume and quality to receive one implant.
Can walking alone, and come to hospital.
Key exclusion criteria
current use of bisphosphonate administration.
Having a history of head and neck radiation.
Having heavy systemic disorders.
Heavy smokers.
Having infections.
Undergoing radiation therapy and chemotherapy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Digital dentistry
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL
03-5803-5563
m.kanazawa.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Kanazawa |
Organization
Tokyo Medical and Dental University
Division name
Graduate school, Digital dentistry
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
TEL
03-5803-5563
Homepage URL
http://www.tmd.ac.jp/ore/patient/patient2/tiral2.html
m.kanazawa.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
ITI Research Grant
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dental Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8549, Japan
Tel
03-5803-5404
d-hyoka.adm@cmn.tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
ITI Research Grant 1025_2014
Org. issuing International ID_1
ITI Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 11 | 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
21
Results
implant survival rate 95.5%
Results date posted
| 2023 | Year | 07 | Month | 20 | Day |
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 | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019591
