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

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Enrolling

Conditions: Gingival Recession

Treatments: Device: VCMX; Drug: Amoxicillin 500mg; Drug: Sodium dipyrone; Procedure: i-PRF; Procedure: CAF; Drug: Chlorhexidine rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT05916742

VCMX+iPRF

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Presence of RT1 (Cairo et al., 2011) buccal single gingival recession (GR) on vital upper or lower canines and premolars with intact root surface (visible CEJ).
• Presence of dentin hypersensitivity (HD) and/or esthetic concerns related to GR.
• Adults > 18 years old.
• Systemically health.
• No signs of active periodontal disease.
• Full-mouth plaque and bleeding score ≤ 20%.
• Written informed consent given.

Exclusion criteria

• Smoking.
• Contraindication for periodontal surgery.
• Pregnancy.
• Presence of orthodontic braces.
• Medications known to interfere with periodontal healing.
• Use of anticoagulants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

CAF+VCMX+i-PRF

Experimental group

Description:

The surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Subsequently, a VCMX functionalized with injectable platelet rich-fibrin (I-PRF) will be placed at the cemento-enamel junction (CEJ) level and stabilized in the adjacent interdental connective beds by interrupted sutures. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.

Treatment:

Drug: Chlorhexidine rinse

Procedure: i-PRF

Procedure: CAF

Drug: Amoxicillin 500mg

Drug: Sodium dipyrone

Device: VCMX

CAF+VCMX

Experimental group

Description:

The surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Subsequently, a VCMX will be placed at the cemento-enamel junction (CEJ) level and stabilized in the adjacent interdental connective beds by interrupted sutures. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.

Treatment:

Drug: Chlorhexidine rinse

Procedure: CAF

Drug: Amoxicillin 500mg

Drug: Sodium dipyrone

Device: VCMX

CAF

Active Comparator group

Description:

The surgical procedure for root coverage will be the trapezoidal-type of coronally advanced flap previously described (de Sanctis \& Zucchelli 2007). Thus, it will start with two divergent releasing incisions lateral to the gingival recession defect. These releasing incisions will then be united by a sulcular incision, and the flap will be raised beyond the mucogingival junction. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.

Treatment:

Drug: Chlorhexidine rinse

Procedure: CAF

Drug: Amoxicillin 500mg

Drug: Sodium dipyrone