NCT05916742

Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

Functionalization of a Volume-stable Collagen Matrix (VCMX) Using Injectable Platelet Rich Fibrin (i-PRF) for the Treatment of Single Gingival Recession

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. However, despite the excellent clinical results obtained, the use of subepithelial connective tissue graft is related to an increased risk of trans and postoperative bleeding, a longer duration of the surgical procedure and greater postoperative pain and morbidity. To overcome these limitations and increase patient acceptance, new biomaterials have been developed as possible alternatives to the use of connective tissue graft. Recently, tissue engineering has been investigating collagen matrices as carriers of biologically active substances. In vitro and in vivo studies have shown that the biofunctionalization of these matrices using injectable platelet rich-fibrin (i-PRF) can optimize the healing process of soft tissues using own's patient regenerative components. However, although it has promising potential, clinical studies evaluating the performance of functionalized collagen matrices are still scarce in the literature. Thus, the present study aims to evaluate the clinical, esthetic, patient-centered, immuno and microbiological results of the use of the biofunctionalized volume stable collagen matrix (VCMX) for the treatment of single gingival recessions RT1. For such purpose, a randomized controlled clinical trial of superiority, parallel and blind will be carried out. Seventy-five patients with RT1 single gingival recession will be selected, who will be randomly allocated to one of the following groups: CAF+VCMX+i-PRF (n = 25), coronally advanced flap associated with VCMX functionalized with i-PRF; CAF+VCMX (n=25), coronally advanced flap associated with VCMX; and CAF group (n = 25), coronally advanced flap alone (CAF). The groups will be compared regarding clinical, esthetic and patient-centered outcomes at the baseline, three and six months after the surgical procedure. The microbiological evaluation will be performed at baseline, three and six months after surgery and the concentration of inflammatory markers and growth factors will be assessed before the procedure and 3, 7, 14, 30 and 60 days after treatment.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	CAF	Periodontal surgical technique to treat gingival recessions
PROCEDURE	i-PRF	Blood-derived biomaterial. Two sterile plastic tubes (Process for PRF, Nice, France) with a volume of 10 ml will be used to generate fluid blood concentrate. After blood collection, the tubes will be centrifuged using a Duo centrifuge (Process for PRF, Nice, France) (fixed angle rotor with a radius of 110 mm) following the protocol proposed by Choukroun et al. (2018) (600 rpm; 8 min).
DEVICE	VCMX	Porcine derived collagen matrix.
DRUG	Sodium dipyrone	All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
DRUG	Chlorhexidine rinse	All participants will be instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
DRUG	Amoxicillin 500mg	Participants enrolled in the CAF+VCMX and CAF+VCMX will be instructed to take amoxicillin 500mg (8 hours/8 hours, during 7 days) after the surgical procedures.

Timeline

• Start date: 2022-04-15
• Primary completion: 2023-12-01
• Completion: 2023-12-18
• First posted: 2023-06-23
• Last updated: 2023-06-23

Locations

1 site across 1 country: Brazil