UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028711 |
|---|---|
| Receipt number | R000032865 |
| Scientific Title | Investigation of prognostic indicators for complete denture therapy |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2025/08/27 14:15:41 |
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Basic information
Public title
Investigation of prognostic indicators for complete denture therapy
Acronym
The prognostic indicators for complete denture therapy
Scientific Title
Investigation of prognostic indicators for complete denture therapy
Scientific Title:Acronym
The prognostic indicators for complete denture therapy
Region
| Japan |
Condition
Condition
Edentulous patients
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the prognostic indicators for complete denture therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral Health Related Quality of Life (OHRQoL)
Key secondary outcomes
Denture satisfaction
Quality of denture
Ability of mastication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Complete denture fabrication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Edentulous patients
Patients who wear complete denture.
Patients who wish to replace their complete denture.
Patients that can attend on their own.
Key exclusion criteria
Psychiatric disorders
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Minakuchi |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5586
s.minakuchi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Medical and Dental University
Division name
Graduate school of Medical and Dental Sciences, Gerodontology and Oral Rehabilitation
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5586
Homepage URL
http://www.tmd.ac.jp/ore/top/research/research.html
y.sato.gerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-7305
d-hyoka.adm@cmn.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付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.tmd.ac.jp/ore/
Publication of results
Partially published
Result
URL related to results and publications
http://www.tmd.ac.jp/dept/dentistry/gerd/results/index.html
Number of participants that the trial has enrolled
432
Results
Significant relationships were found among ridge form, denture quality, neuroticism, and xerostomia as prognostic factors. The outcomes of this study were denture satisfaction, patients' perception of chewing ability, and oral health related quality of life. In the future study, it is desirable to incorporate the above outcomes, and to incorporate dietary instruction and general health status in addition to the conventional prognostic factors, since the subjects are generally elderly.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population consisted of systemically healthy patients who attended the Dental Hospital of Tokyo Medical and Dental University requesting new complete dentures.
Participant flow
The study population consisted of systemically healthy patients who attended the Dental Hospital of Tokyo Medical and Dental University requesting new complete dentures. Exclusion criteria were the following three conditions: systemic disease affecting OHRQoL (dementia, temporo-mandibular joint pain, and oral dyskinesia); daily use of denture adhesive; no current use of dentures. Base data was taken before fabrication of dentures. Outcome was taken before fabrication of dentures and after termination of adjustment.
Adverse events
nothing in particular
Outcome measures
Oral health related quality of life, patient's satisfaction with complete dentures, patients' perception of chewing ability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2006 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032865
