Use of Platelet Rich Fibrin in Addition to CAF and SCTG for Treatment of Gingival Recession

February 22, 2021 updated by: Sarah Elbanna, Cairo University

The Use of Coronally Advanced Flap and Subepithelial Connective Tissue Graft With or Without Platelet Rich Fibrin in the Treatment of Miller Class I or II Gingival Recession: a Randomized Clinical Trial

This research will be conducted in an attempt to achieve complete root coverage with physiologic probing depth and a harmonious view with the adjacent tissues using Platelet rich fibrin in conjunction with Coronally advanced flap and subepithelial connective tissue graft.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study population will be divided into 2 groups:

Group 1:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft. The patients should be non-smoker, medically free and above 18 years

Group 2:

Patients suffering from Miller class I or II gingival recession will be treated with a coronally advanced flap in conjunction with a sub-epithelial connective tissue graft and platelet rich fibrin. the patients should meet the same inclusion criteria mentionned above.

Study Type

Interventional

Enrollment (Actual)

28

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, 12345
        • Faculty of dentistry

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- 1) Patients 18 years and older 2) Buccal recession defects classified as either Miller class I or II gingival recession.

3) Clinical indication and/or patient request for recession coverage 4) Good oral hygiene

Exclusion Criteria:

- 1) Miller Class III and IV gingival recession. 2) Any systemic diseases or any medication. 3) Pregnancy. 4) Patients undergoing radiotherapy. 5) Handicapped and mentally retarded patients. 6) Current and former smokers as smoking is a contra-indication for plastic periodontal surgery .

7) Teeth with cervical restorations, abrasion

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CAF+SCTG+PRF
The patients suffering from class I or II gingival recession in the intervention group will receive a subepithelial connective tissue graft (SCTG) covered by platelet rich fibrin membrane (PRF) followed by a coronally advanced flap (CAF)
Procedure: CAF +SCTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Other Names:
  • CTG
Other: platelet rich fibrin
in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession
Other Names:
  • PRF
ACTIVE_COMPARATOR: CAF+SCTG
Control group patients with class I or II gingival recession will receive treatment that consists of CAF+SCTG only
Procedure: CAF +SCTG
the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
Other Names:
  • CTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession Depth
Time Frame: baseline-3 months-6 months
measured from the cemento-enamel junction to the margin of the gingiva at the mid-buccal point of the teeth at basline, 3 months and 6 months. It is recorded in millimeters (mm) with lower values mean better outcome.
baseline-3 months-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession Width
Time Frame: baseline-3 months-6 months
It was measured as the distance from mesial and distal papillae along the CEJ. It is recorded in millimeters (mm) where lower values means a better outcome.
baseline-3 months-6 months
Root Coverage Gain
Time Frame: at 6 months
(preoperative vertical recession - postoperative vertical recession/preoperative vertical recession) x 100.
at 6 months
Probing Depth
Time Frame: baseline-3 months-6 months
measured from the gingival margin to the base of the pocket probe at the midbuccal point of the teeth. Its is recorded in millimeters (mm) where lower values mean better outcome.
baseline-3 months-6 months
Clinical Attachment Level
Time Frame: baseline-3 months-6 months
measured from the CEJ to the base of the sulcus at the midbuccal point of the teeth. Its is recorded in millimeters (mm).
baseline-3 months-6 months
Gingival Biotype
Time Frame: baseline-3 months-6 months
under local anesthesia from 3 mm below the gingival margin trans-gingivally piercing tissues horizontally, perpendicular to the long axis of the tooth until it contacts bone. Its is recorded in millimeters (mm) where higher values mean better outcome.
baseline-3 months-6 months
Width of Keratinized Gingiva
Time Frame: baseline-3 months-6 months
from the margin of the gingiva to the mucogingival junction at the midbuccal point of the teeth. Its is reported in millimeters where higher values mean better outcome.
baseline-3 months-6 months
Patient Satisfaction
Time Frame: questionnaire given to the patient 6 months after the surgery

printed yes/ no questionnaire with 3 questions:

  1. would you do this surgery again?
  2. would you recommend this treatment to others?
  3. are you satisfied with the results?
questionnaire given to the patient 6 months after the surgery
Root Coverage Esthetic Score (RES)
Time Frame: 6 months

The RES system evaluates 5 variables 6 months after surgery: Zero, 3, or 6 points are used for the evaluation of the position of the gingival margin (GM). A score of 0 or 1 point is used for each of the following variables: marginal tissue contour (MTC), soft tissue texture (STT), mucogingival junction (MGJ) alignment, and gingival color (GC). the points are then summed up to obtain one figure representing the RES.

minimum value:0 maximum value: 10 which means better outcome for RES
6 months
Post Operative Pain
Time Frame: after 2 weeks from surgery
Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable') for the first 2 weeks postoperatively
after 2 weeks from surgery

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Azza Ezzelarab, Professor of periodontics, Faculty of dentistry, Cairo university
  • Study Director: Noha Ghallab, Professor of periodontics, Faculty of dentistry, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (ACTUAL)

June 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sarahelbanna84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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