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

NCT ID: NCT03814707

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

\- 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

..

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
both the participants and the investigator can't be blinded only outcome assessor will be blinded .

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Topical application of 0.2% hyaluronic acid gel

Intervention Type DRUG

Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting

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.

Group Type EXPERIMENTAL

Platelet rich fibrin

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

gengigel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role collaborator

mostafa soliman

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

mostafa soliman

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mona M Shoeib, P.H.D

Role: STUDY_DIRECTOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dental Medicine - Cairo University -

Giza, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mostafa M Soliman, B.D.S

Role: CONTACT

002-01007034062

Mona M Shoeib, P.H.D

Role: CONTACT

002-01223102216

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mostafa M Soliman, B.D.S

Role: primary

002-01007034062

Mona M Shoeib, P.H.D

Role: backup

002-01223102216

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEBD-CU-2018-09-17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hyaluronic Acid Gel in Ridge Preservation
NCT06176937 COMPLETED PHASE4