- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439068
A-PRF and CGF in Palatal Donor Site Healing (FGG)
Effects on Patients' Postoperative Morbidity and Donor Site Wound Healing of A-PRF and CGF Application After Free Gingival Graft Harvesting: A Comparative Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
The objective of this study was to compare and evaluate the effects of concentrated growth factor (CGF) and advanced platelet-rich fibrin (A-PRF) clot membranes on palatal epithelial wound healing and postoperative discomfort following free gingival graft (FGG) harvesting.
Fourty-five patients who underwent FGG harvesting were randomly assigned to three groups: (1) control group (n=15), receiving only a sterile gelatin sponge; (2) A-PRF group (n=15), receiving A-PRF clot membranes; and (3) CGF group (n=15), receiving CGF clot membranes at the donor site. The epithelization rate, color match, and sensation scores of the palatal wound were assessed at 1, 2, 3, and 4 weeks postoperatively. Pain levels, analgesic consumption, and bleeding time were self-reported by patients for the first 7 days of healing.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Ordu, Turkey (Türkiye), 52100
- Ordu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- at least 18 years old,
- without systemic or periodontal diseases,
- without medical contraindications to periodontal surgery
- with full-mouth plaque control scores ≤ 20%
- Gingival index scores ≤ 1
Exclusion Criteria:
- smoking habits,
- diabetes mellitus,
- pregnancy or lactation,
- removable upper denture,
- regular medication that could interpose the healing process, undergoing bisphosphonate therapy, history of radiation therapy of the jaws, and follow-up consults
Study Plan
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: Advanced platelet-rich fibrin
Advanced platelet-rich fibrin clot membranes on palatal epithelial wound after harvesting free gingival graft
|
Advanced platelet-rich fibrin membranes and free gingival graft
|
|
Active Comparator: Concentrated growth factor
Concentrated growth factor clot membranes on palatal epithelial wound after harvesting free gingival graft
|
Concentrated growth factor membranes and free gingival graft
|
|
Placebo Comparator: Sterile gelatin sponge
Sterile gelatin sponge on palatal epithelial wound after harvesting free gingival graft
|
Sterile gelatin sponge and free gingival graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epithelialization
Time Frame: Baseline
|
Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface
|
Baseline
|
|
Epithelialization
Time Frame: 1 week post-surgery
|
Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface
|
1 week post-surgery
|
|
Epithelialization
Time Frame: 2 week post-surgery
|
Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface
|
2 week post-surgery
|
|
Epithelialization
Time Frame: 3 week post-surgery
|
Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface
|
3 week post-surgery
|
|
Epithelialization
Time Frame: 4 week post-surgery
|
Rate of re-epithelialization with re-total, partial, or none by dropping hydrogen peroxide (3%) on the wound surface
|
4 week post-surgery
|
|
Pain perception
Time Frame: Baseline
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
Baseline
|
|
Pain perception
Time Frame: 1st day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
1st day after surgery
|
|
Pain perception
Time Frame: 2nd day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
2nd day after surgery
|
|
Pain perception
Time Frame: 3th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
3th day after surgery
|
|
Pain perception
Time Frame: 4th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
4th day after surgery
|
|
Pain perception
Time Frame: 5th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
5th day after surgery
|
|
Pain perception
Time Frame: 6th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
6th day after surgery
|
|
Pain perception
Time Frame: 7th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
7th day after surgery
|
|
Pain perception
Time Frame: 14th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
14th day after surgery
|
|
Pain perception
Time Frame: 21st day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
21st day after surgery
|
|
Pain perception
Time Frame: 28th day after surgery
|
Presence of pain perception on the Visual Analog Scale (VAS) pain scores (0: no pain, 1: minimal pain, 10: severe pain)
|
28th day after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Figen Öngöz Dede, Prof, Ordu Universitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020\159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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