Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft

August 9, 2018 updated by: Haya Hesham, Cairo University

Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study

Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11311 to 11668
        • Recruiting
        • faculty of oral and dental medicine, Cairo university
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age range 25-50 years.
  • Non- restorable teeth indicated for extraction.
  • Good oral hygiene.
  • Intact facial and lingual plates of bone, without infection or pathosis.
  • Adequate apiacl bone for primaru stability

Exclusion Criteria:

  • Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
  • Presence of periodontal and/or periapical infection.
  • Smokers.
  • Non-compliant patients.
  • Pregnancy or lactation in females.
  • History of head and neck radiotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF (Platelet -rich fibrin) group
Extraction of the tooth followed by Platelet rich fibrin placed in the socket covered bu platelet rich fibrin membrane for socket preservation.
Other: platelet rich fibrin
platelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane.
Active Comparator: Free gingival graft group
Extraction of the tooth followed by using free gingival graft to cover the socket for socket preservation.
Other: Free gingival graft
Free gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue profile change
Time Frame: 6 months
Optical scanning by optical scanner at baseline to the preoperative cast of the related area, then optical scanning to postoperative cast of the surgical area after 6 months. Then, superimposition between the two scans of the casts will be performed to measure the difference or change in the amount of soft tissue profile measured in millimeters between baseline and at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal bone level change
Time Frame: 6 months

measured by Cone beam computed tomography (CBCT) taking the neighboring teeth as reference points, with superimposition between readings at baseline and at 6 months.

Superimposition will identify the difference or change in crestal bone level measured in millimeters between baseline and at 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • version 3 (Protocol Version)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After reaching for the primary and secondary outcomes, international publication will be performed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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