Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession

NCT03712852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-29

Study results available
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Summary

Gingival thickness plays a key role not only in the etiology but also in the treatment of gingival recessions. a thin marginal tissue lining the hard periodontal tissues seems to be one of the main risk factor for the onset of gingival recession ; more recently, authors reported that as the gingival thickness decreases, the gingival recession severity increases . When gingival inflammation occurs, if the tissue is thin the consequent destruction can quickly produce a gingival recession (GR) .

When treating a gingival recession, the clinician should aim not only to completely cover the exposed root surface but also to prevent a future recession recurrence Currently, CAF associated with graft is considered as the gold standard for exposed root coverage; this technique has demonstrated high rates in gingival recession reduction and positive predictability in obtaining complete root coverage . However, some disadvantages about this surgical approach can be easily highlighted: patients experience more discomfort, longer chair-time it's necessary and a second wound area is created . On the other hand, CAF procedure alone does not require a second surgical site, with better post-operative course, also reducing the surgical time. However, long term-studies report lower probability of complete root coverage when using the CAF technique without a simultaneous increase of the gingival thickness as compared to CAF+graft treatment.

In this scenario, The Platelet rich fibrin (PRF) could be a valuable alternative treatment of gingival defects. It's a platelet concentrate, obtained by a fast and simple procedure that does not require anticoagulant and bovine thrombin . It can also be categorized as a live tissue thanks to platelets, leukocytes, growth factors and stem cells trapped in a polymerized fibrin mesh. PRF is used in various fields of regenerative medicine; It promotes stabilization and revascularization of the flaps, contributes to soft tissue wound healing and reduces post-operative discomfort.

The purpose of this clinical study will be to determine if the combination of platelet rich fibrine membrane with a modified coronally advanced flap (MCAF) improved the gingival biotype compared to CAF + graft or CAF alone.

Conditions

  • Gingival Recession

Interventions

PROCEDURE

PRF+CAF treated patients

Patients will be treated by coronally advanced flap with addition of PRF membrane

PROCEDURE

SCTG+ CAF treated patients

Patients will be treated by coronally advanced flap with addition of SCTG graft

PROCEDURE

CAF treated patients

Patients will be treated by coronally advanced flap

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-20
Primary Completion
2019-07-30
Completion
2019-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712852 on ClinicalTrials.gov