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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Topical application of 0.2% hyaluronic acid gel
Platelet rich fibrin
Sponsored by
mostafa soliman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring gingival recession, gingival augmentation, free gingival graft, platelet rich fibrin in wound healing, 2 steps free gingival graft, hyaluronic acid in wound healing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dental Medicine - Cairo University -Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Topical application 0.2%Hyaluronic Acid

Platelet Rich Fibrin

Arm Description

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

Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.

Outcomes

Primary Outcome Measures

post operative pain
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

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

Full Information

First Posted
January 13, 2019
Last Updated
January 25, 2019
Sponsor
mostafa soliman
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03814707
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
mostafa soliman
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 . .
Detailed Description
- Patients of both groups will be subjected to: Case history including personal data, medical, surgical history and family history. 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 ..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
both the participants and the investigator can't be blinded only outcome assessor will be blinded .
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical application 0.2%Hyaluronic Acid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Platelet Rich Fibrin
Arm Type
Experimental
Arm Description
Palatal donor site will receive a platelet rich fibrin and then will be sutured by criss cross suture then covered by periodontal pack.
Intervention Type
Drug
Intervention Name(s)
Topical application of 0.2% hyaluronic acid gel
Other Intervention Name(s)
gengigel
Intervention Description
Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin
Intervention Description
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.
Primary Outcome Measure Information:
Title
post operative pain
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
wound healing
Description
Early Wound Healing Index (EHI) , measuring unit Binary (YES/NO)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa M Soliman, B.D.S
Phone
002-01007034062
Email
drshoo_2010@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mona M Shoeib, P.H.D
Phone
002-01223102216
Email
monashoeib@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona M Shoeib, P.H.D
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dental Medicine - Cairo University -
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Soliman, B.D.S
Phone
002-01007034062
Email
drshoo_2010@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mona M Shoeib, P.H.D
Phone
002-01223102216
Email
monashoeib@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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