UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028680 |
|---|---|
| Receipt number | R000032833 |
| Scientific Title | Comparative Study of Overdentures Retained by Cylindrical and Conical Telescopic Attachments in cases with few Remaining Teeth |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2021/08/21 19:48:27 |
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Basic information
Public title
Comparative Study of Overdentures Retained by Cylindrical and Conical Telescopic Attachments in cases with few Remaining Teeth
Acronym
Comparative Study of Overdentures Retained by Cylindrical and Conical Telescopic Attachments
Scientific Title
Comparative Study of Overdentures Retained by Cylindrical and Conical Telescopic Attachments in cases with few Remaining Teeth
Scientific Title:Acronym
Comparative Study of Overdentures Retained by Cylindrical and Conical Telescopic Attachments
Region
| Asia(except Japan) |
Condition
Condition
Patients with few remaining teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the functional quality of overdentures retained by telescopic attachments and their effects on periodontal tissues according to the used telescopic attachment type in cases with few remaining teeth
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Masticatory efficiency
2. Some periodontal indicators (PD, CAL, abutment teeth mobility, alveolar bone loss)
Key secondary outcomes
1. Dentures underlying mucosa evaluation
2. Technical failure rates
3. Abutments other evaluations
4. Patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Overdenture retained by cylindrical telescopic attachments
Interventions/Control_2
Overdenture retained by conical telescopic attachments
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
1. Patients with few remaining teeth (2-4 teeth)
2. The remaining teeth should be distributed in both sides of jaw
3. The remaining teeth shouldnt include molars
Key exclusion criteria
1. Remaining teeth with considerable mobility
2. Remaining teeth with severe bone loss
3. Remaining teeth are not distributed in both sides of jaw
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mohammad Ayham Hakkoum |
Organization
Damascus university - Faculty of Dentistry
Division name
Removable Prosthodontics
Zip code
Address
Damascus
TEL
00963932071296
drayham@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mohammad Ayham Hakkoum |
Organization
Damascus university - Faculty of Dentistry
Division name
Removable Prosthodontics
Zip code
Address
Damascus
TEL
00963932071296
Homepage URL
drayham@yahoo.com
Sponsor or person
Institute
Damascus University
Institute
Department
Personal name
Funding Source
Organization
Damascus University
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
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
Damascus University - Faculty of Dentistry (Damascus)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 16 | 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
| 2016 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 05 | 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 | 16 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032833
| Research Plan | |
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| Registered date | File name |
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