The Effect of (L-PRF) Membrane in The Treatment of Gingival Recession

November 3, 2020 updated by: Zainab Hafez Abdel Rahman, Ain Shams University

The Effect of Leukocyte Platelet Rich Fibrin(L-PRF) Membrane in The Treatment of Localized Gingival Recession (Randomized Controlled Clinical Trial)

evaluation of the use of L-PRF membrane with coronally repositioned flap in treatment of localized gingival recession (Class I & II) in comparison with the use of connective tissue graft

Study Overview

Status

Completed

Detailed Description

Twenty patients, who are candidates for gingival recession coverage, will participate in this prospective clinical trial.

Group 1(10 patients) :

Coronally repositioned flap will be done and L PRF membrane will be placed into the tissues

Group 2 (Control group)(10 patients) :

Coronally repositioned flap will be done with sub epithelial connective tissue Parameters

  • Clinical evaluation of percentage of root coverage and keratinized tissue width
  • Esthetic outcome evaluation Will be done using the root coverage esthetic score (Cairo et al. 2009) that include

Both evaluations will be done at 3, 6 and 9 months

Study Type

Interventional

Enrollment (Actual)

20

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

      • Cairo, Egypt
        • Faculty of Dentistry Ain Shams University

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:

  • Systemically free patients (American Society of Anesthesiologists I; ASA I).
  • Age range (20 -40) years.
  • Good compliance with the plaque control instructions following initial therapy.
  • Patients diagnosed with Miller class I or II in anterior and premolar teeth
  • Availability for follow up and maintenance program.

Exclusion Criteria:

  • Patient suffering from periodontitis
  • Presence of smoking habit.
  • Presence of occlusion interference.
  • Pregnant and lactating females.
  • Vulnerable group of patients (handicapped, mentally retarded and prisoners).

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: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Leukocyte Platelet Rich Fibrin
Leukocyte Platelet Rich Fibrin will be used
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Other Names:
  • sub epithelial connective tissue
ACTIVE_COMPARATOR: connective tissue
connective tissue will be used
the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
Other Names:
  • sub epithelial connective tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recession treatment
Time Frame: 9 months

2-Esthetic outcome evaluation was done using Root coverage esthetic score (RES) system ( Cairo et al. 2009) the RES include the following parameters

• Level of the gingival margin (GM):(minimum) Zero points = failure of root coverage (gingival margin apical or equal to the baseline recession); 3 points = partial root coverage;(maximum) 6 points = CRC.

9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
soft tissue thickness (Volumetric assessment)
Time Frame: 9 months
Preoperatively a cast was made and scanned. At 9 months after surgical procedure the same procedure was done to determine the soft tissue thickness after the surgery. The difference between the tissue thickness before and after was used to determine the efficacy of the different surgical grafting materials used.
9 months

Collaborators and Investigators

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

Investigators

  • Study Chair: ahmed abdel aziz, co professor, Faculty of Dentistry Ain Shams 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)

December 1, 2018

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

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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