CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
PRF+CAF treated patients +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03712852
NCT03712852N/ACompleted

Gingival Phenotype Changes After Different Periodontal Plastic Surgical Techniques.

G. d'Annunzio University·interventional·Posted Oct 19, 2018·Updated Nov 29, 2022

In Brief

A clinical study evaluating PRF+CAF treated patients, SCTG+ CAF treated patients, and 1 other intervention for Gingival Recession. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 19, 2018
Enrollment StartOct 20, 2018
Primary CompletionJul 30, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.7 years ago

Interventions

PRF+CAF treated patientsprocedure

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

SCTG+ CAF treated patientsprocedure

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

CAF treated patientsprocedure

Patients will be treated by coronally advanced flap