Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects
Primary Purpose
Periodontal Pocket
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Regenerative therapy
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Pocket
Eligibility Criteria
Inclusion Criteria:
- No systemic diseases that could influence the outcome of therapy
- Good compliance for plaque control instructions after initial therapy
- Vital teeth
- Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
- Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,
Exclusion Criteria:
- Pregnant females and patients presented with opened interproximal contact
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PRF
MPP
Arm Description
Platelets rich fibrin,
Marginal periosteal pedicle
Outcomes
Primary Outcome Measures
Intrabony defect
measurements of intrabony gain from CEJ to base of defect
Secondary Outcome Measures
Full Information
NCT ID
NCT02359539
First Posted
November 16, 2014
Last Updated
February 9, 2015
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT02359539
Brief Title
Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects
Official Title
Marginal Periosteal Pedicle Flap and Platelet Rich Fibrin Barriers for the Treatment of Periodontal Intrabony Defects -Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.
Detailed Description
Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. Subjects were randomly divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10 patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRF
Arm Type
Experimental
Arm Description
Platelets rich fibrin,
Arm Title
MPP
Arm Type
Experimental
Arm Description
Marginal periosteal pedicle
Intervention Type
Procedure
Intervention Name(s)
Regenerative therapy
Other Intervention Name(s)
Guided tissue regeneration
Intervention Description
Periosteal pedicle, Platelets rich fibrin
Primary Outcome Measure Information:
Title
Intrabony defect
Description
measurements of intrabony gain from CEJ to base of defect
Time Frame
9 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
No systemic diseases that could influence the outcome of therapy
Good compliance for plaque control instructions after initial therapy
Vital teeth
Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,
Exclusion Criteria:
Pregnant females and patients presented with opened interproximal contact
12. IPD Sharing Statement
Learn more about this trial
Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects
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