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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028680
Receipt No. 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 2019/02/17

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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
Email 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
Email drayham@yahoo.com

Sponsor
Institute Damascus University
Institute
Department

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
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 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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 21 Day
Last follow-up date
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
2019 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032833

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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