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NOT YET RECRUITING
NCT07613775
NA

Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

Summary

Gingival recession is a clinical condition in which the gingival margin is displaced apically, exposing the root surface. This condition may be associated with esthetic concerns, dentin hypersensitivity, and difficulties in oral hygiene. Subepithelial connective tissue grafting is considered a standard surgical approach for root coverage, but it requires harvesting tissue from the palate, which may increase postoperative discomfort. Volume-stable xenogeneic collagen matrices have been proposed as an alternative biomaterial to reduce the need for a palatal donor site. This randomized controlled clinical trial will compare a volume-stable xenogeneic collagen matrix with an autogenous subepithelial connective tissue graft for the treatment of multiple gingival recessions. Participants will be allocated to one of two treatment groups. The test group will receive root coverage surgery using a volume-stable collagen matrix, while the control group will receive root coverage surgery using a subepithelial connective tissue graft. Clinical, patient-reported, esthetic, and digital outcomes will be assessed at baseline and during follow-up visits up to 12 months. The primary outcome will be the change in gingival recession depth from baseline to 12 months. Secondary outcomes will include keratinized tissue width, gingival thickness, percentage of root coverage, complete root coverage, dentin hypersensitivity, patient-reported satisfaction, early wound healing, and digital volumetric changes assessed by intraoral scanning.

Official title: Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-01

Completion Date

2028-12-01

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DEVICE

Volume-stable xenogeneic collagen matrix (VCMX)

A volume-stable xenogeneic collagen matrix will be used as a soft-tissue substitute for root coverage surgery. The matrix will be placed over the recession defects and covered by a coronally advanced flap.

PROCEDURE

Subepithelial connective tissue graft (SCTG)

An autogenous subepithelial connective tissue graft will be harvested from the palate and used for root coverage surgery. The graft will be placed over the recession defects and covered by a coronally advanced flap.

Locations (1)

School of Dentistry of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil