|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 October 2015 |
|
Main ID: |
NCT02178384 |
|
Date of registration:
|
27/06/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Management of Loading Forces Distribution in Mandibular Distal-extension Prostheses
|
|
Scientific title:
|
An In-vivo Study to Evaluate Three Methods of Managing the Distribution of Loading Forces in Mandibular Distal-extension Prostheses (Class I Kennedy's Classification) |
|
Date of first enrolment:
|
June 2014 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02178384 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Syrian Arab Republic
| | | | | | | |
|
Contacts
|
|
Name:
|
Fadi Alhaji Jnaid, DDS MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus |
|
|
Name:
|
Alaa' Salloum, DDS MSc PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Senior Lecturer, Removable Prosthodontics Department, University of Damascus Dental School, Damascus |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Bilateral distal extension in the mandible (Class I Kennedy's Classification).
- Stable systemic health, including absence of a history of cardiovascular disease.
- No evidence of infection or trauma in the oral region.
- Negative history of syndromes or temporomandibular disorders and parafunction.
Exclusion Criteria:
- Other Classes of Kennedy's Classification
- Patients with ages beyond the accepted age range.
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Mandibular Distal-extension Prostheses
|
|
Intervention(s)
|
|
Device: Precision Attachments
|
|
Procedure: Resilient layer
|
|
Procedure: Altered cast technique
|
|
Primary Outcome(s)
|
|
Soft-tissue vertical displacement (STVD)
[Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery]
|
|
Secondary Outcome(s)
|
|
Cellular changes of the supporting tissues
[Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery]
|
|
Bone absorption of abutment teeth
[Time Frame: This variable will be measured at one month, three months and six months following appliance first delivery]
|
|
Secondary ID(s)
|
|
UDDS-RemPro-01-2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|