Back to resultsMicrobial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture (splitmouth)
Primary Purpose
Polyetheretherketone
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEEK
Sponsored by
About this trial
This is an interventional treatment trial for Polyetheretherketone
Eligibility Criteria
Inclusion Criteria:
- patients are medically free
Exclusion Criteria:
- patients with badly broken abutments
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
non metallic
metallic denture base
Arm Description
PEEK denture base,
cobalt chromium alloy denture base
Outcomes
Primary Outcome Measures
microbial culture using number of clonies after insertion by 3 months
microbial adhesion will be measured using continous cultures to assess number of colonies
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03008317
Brief Title
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture
Acronym
splitmouth
Official Title
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyetheretherketone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non metallic
Arm Type
Active Comparator
Arm Description
PEEK denture base,
Arm Title
metallic denture base
Arm Type
Placebo Comparator
Arm Description
cobalt chromium alloy denture base
Intervention Type
Device
Intervention Name(s)
PEEK
Other Intervention Name(s)
polyetheretherketone denture base, cobalt chromium alloy denture base
Intervention Description
a metallic denture base
Primary Outcome Measure Information:
Title
microbial culture using number of clonies after insertion by 3 months
Description
microbial adhesion will be measured using continous cultures to assess number of colonies
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients are medically free
Exclusion Criteria:
patients with badly broken abutments
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture
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