Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions
Gingival Recession
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 40 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
This study is a randomized controlled clinical trial designed to evaluate the clinical performance of a volume-stable xenogeneic collagen matrix compared with an autogenous subepithelial connective tissue graft in the treatment of multiple gingival recessions.
Eligible participants presenting multiple gingival recessions will be recruited and allocated to one of two parallel treatment groups. In the test group, participants will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. In the control group, participants will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
Clinical assessments will include gingival recession depth, keratinized tissue width, probing depth, clinical attachment level, gingival thickness, percentage of root coverage, and complete root coverage. Patient-reported outcomes will include dentin hypersensitivity, postoperative comfort, esthetic satisfaction, and acceptance of the procedure. Standardized clinical photographs and intraoral scans will be obtained during follow-up. Digital analyses will be used to assess changes in soft tissue volume over time.
The primary endpoint will be the change in gingival recession depth from baseline to 12 months. Secondary endpoints will include clinical, esthetic, patient-reported, wound healing, and digital volumetric outcomes assessed at predefined follow-up visits.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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.
- Indication for root coverage treatment due to esthetic concern and/or dentin hypersensitivity.
- Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.
- Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.
Exclusion Criteria:
- Current smokers or individuals who stopped smoking less than 12 months before enrollment.
- Decompensated systemic diseases.
- Pregnancy or lactation.
- Active periodontal disease.
- Untreated root caries.
- Previous mucogingival surgery in the study area.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
Volume-Stable Collagen Matrix
Participants in this group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap.
Device: Volume-stable xenogeneic collagen matrix (VCMX)
Subepithelial Connective Tissue Graft
Participants in this group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
Procedure: Subepithelial connective tissue graft (SCTG)
Volume-stable xenogeneic collagen matrix (VCMX) DEVICE
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.
Subepithelial connective tissue graft (SCTG) PROCEDURE
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Gingival Recession Depth
Time frame: Baseline, 3 months, 6 months, and 12 months
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.
Secondary measures
Gingival Recession Width
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
Keratinized Tissue Width
Time frame: Baseline, 3 months, 6 months, and 12 months
Keratinized tissue width will be measured in millimeters from the gingival margin to the mucogingival junction.
Gingival Thickness
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival thickness will be measured in millimeters at the treated sites using a standardized clinical method.
Probing Depth
Time frame: Baseline, 3 months, 6 months, and 12 months
Probing depth will be measured in millimeters from the gingival margin to the bottom of the sulcus or pocket at the treated sites.
Clinical Attachment Level
Time frame: Baseline, 3 months, 6 months, and 12 months
Clinical attachment level will be calculated in millimeters as probing depth plus gingival recession depth.
Percentage of Root Coverage
Time frame: 3 months, 6 months, and 12 months
Percentage of root coverage will be calculated based on the reduction in gingival recession depth from baseline to 12 months.
Complete Root Coverage
Time frame: 3 months, 6 months, and 12 months
Complete root coverage will be defined as the absence of residual gingival recession at the treated site.
Dentin Hypersensitivity
Time frame: Baseline, 3 months, 6 months, and 12 months
Will be assessed after standardized air stimulation using a 0 to 100 visual analog scale. A score of 0 indicates no pain or sensitivity, and a score of 100 indicates the worst imaginable pain or sensitivity. Higher scores indicate worse dentin hypersensitivity.
Patient-Reported Esthetic Satisfaction
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient-reported esthetic satisfaction will be assessed using a 0 to 100 visual analog scale. A score of 0 indicates complete dissatisfaction, and a score of 100 indicates complete satisfaction. Higher scores indicate better esthetic satisfaction.
Digital Volumetric Changes
Time frame: Baseline, 3 months, 6 months, and 12 months
Soft tissue volumetric changes will be assessed using intraoral scans and digital superimposition of three-dimensional Standard Tessellation Language (STL) models.
Early Wound Healing
Time frame: 7 days, 14 days, and 30 days
Early wound healing will be assessed clinically during the postoperative period based on flap margin adaptation, suture stability, edema, inflammation, erythema, fibrin accumulation, tissue necrosis, epithelialization, biomaterial or graft exposure, and overall wound healing pattern.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
School of Dentistry of Ribeirão Preto, University of Sao PauloRibeirão Preto, São Paulo, BrazilRecruiting
Study team and timeline
- Lead sponsor
- University of Sao Paulo
- Study start
- Oct 19, 2026 Actual
- Primary completion
- Oct 1, 2028 Estimated
- Study completion
- Dec 1, 2028 Estimated
- First posted
- May 29, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026