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

Sponsor
mostafa soliman (Other)
Overall Status
Unknown status
CT.gov ID
NCT03814707
Collaborator
Cairo University (Other)
26
Enrollment
1
Location
2
Arms
5.7
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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 .

.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical application of 0.2% hyaluronic acid gel
  • Biological: Platelet rich fibrin
 N/A

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

..

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
both the participants and the investigator can't be blinded only outcome assessor will be blinded .
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 10, 2019
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Topical application 0.2%Hyaluronic Acid

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

Drug: 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
Other Names:
  • gengigel

    		•
    Experimental: 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.

    Biological: Platelet rich fibrin
    Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. wound healing [2 months]

      Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dental Medicine - Cairo University - Giza Egypt 12613

    Sponsors and Collaborators

    • mostafa soliman
    • Cairo University

    Investigators

    • Study Director: Mona M Shoeib, P.H.D, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mostafa soliman, Principle Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03814707
    Other Study ID Numbers:
    • CEBD-CU-2018-09-17
    First Posted:
    Jan 24, 2019
    Last Update Posted:
    Jan 28, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by mostafa soliman, Principle Investigator, Cairo University
    gingival recession
    gingival augmentation
    free gingival graft
    platelet rich fibrin in wound healing
    2 steps free gingival graft
    hyaluronic acid in wound healing
    Additional relevant MeSH terms:
    Pain, Postoperative
    Hyaluronic Acid

    Study Results

    No Results Posted as of Jan 28, 2019