Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03712852
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Paolantonio, G. d'Annunzio University

Brief 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.


Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: PRF+CAF treated patients Procedure: SCTG+ CAF treated patients Procedure: CAF treated patients Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Gingival thickness [ Time Frame: 6 months ]
    the thickness of keratinized tissue recorded at 1 mm from the gingival margin


Secondary Outcome Measures :
  1. Gingival recession [ Time Frame: 6 months ]
    the distance between the cemento enamel junction and the gingival margin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a full-mouth plaque score (FMPS)* and a full-mouth bleeding score (FMBS)* lower than 20%, at the time of surgery
  • to have at least 20 teeth at leat 1 tooth exhibiting a Miller second class of gingival recession .

Exclusion Criteria:

  • no systemic diseases;
  • no coagulation disorders;
  • no medications affecting periodontal status in the previous 6 months;
  • no pregnancy or lactation;
  • no presence of cervical carious lesions,;
  • no periodontal surgery on the experimental sites
  • no smoking habits
  • no inadequate endodontic treatment at the site of surgery
  • no presence of cervical carious lesions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712852


Locations
Layout table for location information
Italy
G. d'Annunzio University
Chieti, CH, Italy, 66100
Sponsors and Collaborators
G. d'Annunzio University

Layout table for additonal information
Responsible Party: Michele Paolantonio, professor and chairman, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT03712852     History of Changes
Other Study ID Numbers: 16102018
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michele Paolantonio, G. d'Annunzio University:
Platelet rich fibrin
sub-epithelial connective tissue
coronally advanced flap

Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy