Clinical trial NCT03814707: Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival Graft
Official title: Clinical Comparison of Platelet Rich Fibrin Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Wound Healing After Free Gingival Graft Harvesting: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: gingival recession
gingival augmentation
free gingival graft
platelet rich fibrin in wound healing
2 steps free gingival graft
hyaluronic acid in wound healing
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-01-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment

* A randomized clinical trial.
* Parallel group study.
* A trial will be carried out in department of periodontology - Faculty of Oral and Dental medicine - Cairo University .
* Equal randomization : participants with equal probabilities for intervention.
* Positive controlled : Both groups receiving treatment.
Primary purpose: TREATMENT

Brief summary: Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure .

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Detailed description: - Patients of both groups will be subjected to:

1. Case history including personal data, medical, surgical history and family history.
2. Clinical Examination.

After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. The free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 .

The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures.

Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was introduced by Choukroun \& coworkers. PRF requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. After collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. After the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack

control group Control group: As the intervention group but the palatal wound will receive a .2% hyaluronic acid gel then covered by periodontal dressing

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Eligibility criteria: Inclusion Criteria for participants:

* Patients with mucogingival defects scheduled for free gingival graft
* Age at least 18 years.
* Not having any systemic disease that could compromise wound healing
* No previous periodontal surgery on the experimental sites.

Exclusion Criteria for participants:

* Systemic diseases that may be a contraindication for any surgeries.
* Loss of maxillary premolars and molars.
* Pregnancy or lactation
* Smoking

Primary outcomes:
measure: post operative pain
timeFrame: 1 week
Secondary outcomes:
measure: wound healing
timeFrame: 2 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dental Medicine - Cairo University -
Study officials:
affiliation: Cairo University
name: Mona M Shoeib, P.H.D
role: STUDY_DIRECTOR
References: