Back to resultsAdvanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects
Primary Purpose
Periodontitis, Adult
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
advanced PRF
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis, Adult
Eligibility Criteria
Inclusion Criteria: patients with periodontal suprabony defects. Exclusion Criteria: pregnant females. smokers. systemic disease that contraindicate surgery
Sites / Locations
- Al-Azhar University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
group 1
group 2
Arm Description
Outcomes
Primary Outcome Measures
clinical evaluation
Rate of probing pocket depth reduction
Secondary Outcome Measures
radiographic evaluation
Rate of bone formation by digital radiography
Full Information
NCT ID
NCT05730153
First Posted
February 7, 2023
Last Updated
March 23, 2023
Sponsor
October University for Modern Sciences and Arts
1. Study Identification
Unique Protocol Identification Number
NCT05730153
Brief Title
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects
Official Title
Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin and Open Debridement in Management of Periodontal Suprabony Defects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
January 27, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement
Detailed Description
two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Title
group 2
Arm Type
Sham Comparator
Intervention Type
Biological
Intervention Name(s)
advanced PRF
Intervention Description
advanced PRF+ surgery
Primary Outcome Measure Information:
Title
clinical evaluation
Description
Rate of probing pocket depth reduction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
radiographic evaluation
Description
Rate of bone formation by digital radiography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with periodontal suprabony defects.
Exclusion Criteria:
pregnant females.
smokers.
systemic disease that contraindicate surgery
Facility Information:
Facility Name
Al-Azhar University, Faculty of Dentistry
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects
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