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.
Adults aged 18 years or older.
Presence of at least two Cairo RT1 gingival recessions in anterior teeth and/or premolars.
Gingival recession depth greater than or equal to 2 mm.
Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.
Current smokers or individuals who stopped smoking less than 12 months before enrollment.
Decompensated systemic diseases.
Pregnancy or lactation.
Active periodontal disease.
Parallel
Volume-stable xenogeneic collagen matrix (VCMX)
DeviceA 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.
Subepithelial connective tissue graft (SCTG)
Procedure/SurgeryAn 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.
Gingival Recession Depth
Gingival recession depth will be measured clinically in millimeters as the distance from the cementoenamel junction to the gingival margin. The main comparison between groups will be performed at 12 months.
Gingival Recession Width
Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
Keratinized Tissue Width
Keratinized tissue width will be measured in millimeters from the gingival margin to the mucogingival junction.
Gingival Thickness
Gingival thickness will be measured in millimeters at the treated sites using a standardized clinical method.
Probing Depth
Probing depth will be measured in millimeters from the gingival margin to the bottom of the sulcus or pocket at the treated sites.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: