UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028100 |
|---|---|
| Receipt number | R000032171 |
| Scientific Title | Oral health-related quality of life of non-metal clasp dentures and shortened dental arch with unilateral mandibular distal-extension edentulism: a within-subject controlled clinical trial |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2020/07/08 16:25:19 |
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Basic information
Public title
Oral health-related quality of life of non-metal clasp dentures and shortened dental arch with unilateral mandibular distal-extension edentulism: a within-subject controlled clinical trial
Acronym
Oral health-related quality of life of non-metal clasp dentures and shortened dental arch with unilateral mandibular distal-extension edentulism: a within-subject controlled clinical trial
Scientific Title
Oral health-related quality of life of non-metal clasp dentures and shortened dental arch with unilateral mandibular distal-extension edentulism: a within-subject controlled clinical trial
Scientific Title:Acronym
Oral health-related quality of life of non-metal clasp dentures and shortened dental arch with unilateral mandibular distal-extension edentulism: a within-subject controlled clinical trial
Region
| Japan |
Condition
Condition
unilateral mandibular distal-extension edentulism
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this clinical trial was to investigate the Oral-related QoL in the patient to which applied NMCDs and RPDs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective evaluation about the patient QOL of three kinds of prosthetic treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
removable partial denture
Interventions/Control_2
non-metal clasp denture
Interventions/Control_3
shortened dental arch
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
I intend for a patient meeting all the following standards.
1.Mandibular free edge loss patient
2.Person in hope of the production of the denture or adjustment
3.The patient that a document agreement by the free will of a patient was provided after enough understanding after having received enough explanation on participating to this study
Key exclusion criteria
The applicable patient intends for even one following houses and excludes it.
1.It is the person with the trouble for a question vote answer
2.The person who has a loss on chin face
3.Person considered that the participation in study is difficult having a systemic anamnesis
4.The person that periodontal treatment is not finished
5.In addition, the patient whom a study person in charge judged to be inappropriate as a subject
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Murata |
Organization
Nagasaki University
Division name
Department of Prosthetic Dentistry, Graduate School of Biomedical Sciences
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7692
hmurata@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadafumi Kurogi |
Organization
Nagasaki University Hospital
Division name
General dentistry
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL
095-819-7692
Homepage URL
kurofumi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032171
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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