- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521467
Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series
Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction:
Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.
Materials and methods:
Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation
Exclusion Criteria:
- High arched palate, medically compromised
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PRF
Platelets Rich Fibrin
|
Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.
|
|
Placebo Comparator: palatal stent
Palatal stent
|
the other group is a control group, had no biologic in the palatal wound, only palatal stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Assessment by Visual Analog Scale (VAS)
Time Frame: 1 week postoperative
|
VAS ranged from 0 (no pain ) to 10 (severe pain)
|
1 week postoperative
|
|
Clinical healing of the palate
Time Frame: 2 weeks postoperative
|
color match, consistency and thickness of palate (Composite measure)
|
2 weeks postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Doaa Adel
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