Platelet Rich Fibrin vs Sub Epithelial Connective Tissue and Coronally Advanced Flap Alone in Gingival Recession
|ClinicalTrials.gov Identifier: NCT03712852|
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : July 31, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gingival Recession||Procedure: PRF+CAF treated patients Procedure: SCTG+ CAF treated patients Procedure: CAF treated patients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||parallel assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Gingival Thickness Changes After Use of Platelet Rich Fibrin Membrane Compared to Sub Epithelial Connective Tissue Graft and Coronally Advanced Flap Alone: A Controlled and Randomized Clinical Trial|
|Actual Study Start Date :||July 2, 2017|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||July 30, 2019|
Active Comparator: PRF+CAF treated patients
Blood samples are collected in four 10-ml tubes without anticoagulant and promptly centrifuged at 3,000 revolutions per minute for 10 minutes The clot, positioned in the middle of the vial, is cut off from the lower red corpuscles part (Fig). The clot is pressed through a calibrated compression system into the PRF box the folded membrane is transferred on a sterile gauze. A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the PRFs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.
Procedure: PRF+CAF treated patients
Patients will be treated by coronally advanced flap with addition of PRF membrane
Active Comparator: SCTG+ CAF treated patients
SCTG is taken from the opposite palate area of gingival defect. The graft is collected with a single incision technique and it is measured and adjusted to 1 mm by measuring with a standard caliper.A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the SCTGs are placed over the exposed root surface, ﬂap is coronally positioned and sutures over the enamel in a tension-free position.
Procedure: SCTG+ CAF treated patients
Patients will be treated by coronally advanced flap with addition of SCTG graft
Active Comparator: CAF treated patients
A modified coronally advanced flap technique (MCAF) is used to treat the recession defect, the flap is sutured over the enamel in a tension free position.
Procedure: CAF treated patients
Patients will be treated by coronally advanced flap
- Gingival thickness [ Time Frame: 6 months ]the thickness of keratinized tissue recorded at 1 mm from the gingival margin
- Gingival recession [ Time Frame: 6 months ]the distance between the cemento enamel junction and the gingival margin
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712852
|G. d'Annunzio University|
|Chieti, CH, Italy, 66100|