- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008317
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture (splitmouth)
December 30, 2016 updated by: Hager essam el azizi, Cairo University
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.
Study Overview
Detailed Description
this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1
Study Type
Interventional
Enrollment (Anticipated)
2
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients are medically free
Exclusion Criteria:
- patients with badly broken abutments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: non metallic
PEEK denture base,
|
a metallic denture base
Other Names:
|
Placebo Comparator: metallic denture base
cobalt chromium alloy denture base
|
a metallic denture base
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
microbial culture using number of clonies after insertion by 3 months
Time Frame: one year
|
microbial adhesion will be measured using continous cultures to assess number of colonies
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
December 20, 2016
First Submitted That Met QC Criteria
December 30, 2016
First Posted (Estimate)
January 2, 2017
Study Record Updates
Last Update Posted (Estimate)
January 2, 2017
Last Update Submitted That Met QC Criteria
December 30, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBC-CU-2016-12-164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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