Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival Graft

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Biological: Platelet rich fibrin; Drug: Topical application of 0.2% hyaluronic acid gel

• Registration Number: NCT03814707
• Lead Sponsor: mostafa soliman

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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Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-10
• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-20
• Study First Posted: 2019-01-24
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28
• Primary Completion: 2019-06-01
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Fibrin	Platelet rich fibrin	Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.
Topical application 0.2%Hyaluronic Acid	Topical application of 0.2% hyaluronic acid gel	Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting and covered by periodontal pack

Primary Outcome Measures

Name	Time	Method
post operative pain	1 week	Questionnaire will be used to evaluate the postoperative pain using visual analogue scale ( VAS) Min score Zero , Max score ten where zero is the best while ten is the worst

Secondary Outcome Measures

Name	Time	Method
wound healing	2 months	Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)

Trial Locations

Locations (1)

Faculty of Dental Medicine - Cairo University -; 🇪🇬 Giza, Egypt