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

NCT03712852 | Completed Results DMC

• 1 other identifier: 16102018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

Platelet-Rich fibrin; Plastic surgery; Phenotype

Outcome Measures

Primary Outcomes (1)

• Gingival Thickness

  the change from baseline measured as the thickness of keratinized tissue recorded at 1 mm from the gingival margin

  baseline and 6 months

Secondary Outcomes (6)

• Gingival Recession

  baseline and 6 months

• Keratinized Tissue

  baseline and 6 months

• Pocket Depth

  baseline and 6 months

• Clinical Attachment Level

  baseline and 6 months

• Patient Reported Outcomes (PROMs)

  2 weeks

Study Arms (3)

PRF+CAF treated patients

ACTIVE COMPARATOR

The clot collected from the blood samples is pressed through a calibrated compression system into the PRF box the folded membrane is measured and adjusted to 1,5 mm, then 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

SCTG+ CAF treated patients

ACTIVE COMPARATOR

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 1,5 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

CAF treated patients

ACTIVE COMPARATOR

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

Interventions

PRF+CAF treated patients PROCEDURE

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

PRF+CAF treated patients

SCTG+ CAF treated patients PROCEDURE

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

SCTG+ CAF treated patients

CAF treated patients PROCEDURE

Patients will be treated by coronally advanced flap

CAF treated patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 maxillary tooth exhibiting a single Miller second class of gingival recession .

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Prof. Michele Paolantonio
• Organization: Università degli studi G. D'ANNUNZIO

mpaolantonio@unich.it

3395204073

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and chairman

Model Details: parallel assignment

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 19, 2018
• Study Start: October 20, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 29, 2022
• Results First Posted: February 10, 2021

Record last verified: 2022-11

Locations

IT (1)