An interventional study of Volume-stable xenogeneic collagen matrix (VCMX) and Subepithelial connective tissue graft (SCTG) in Gingival Recession, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
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.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Also known as: VCMX, Fibro-Gide
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.
Also known as: SCTG
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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival Recession Width
Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
Time frame: Baseline, 3 months, 6 months, and 12 months
Keratinized Tissue Width
Keratinized tissue width will be measured in millimeters from the gingival margin to the mucogingival junction.
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival Thickness
Gingival thickness will be measured in millimeters at the treated sites using a standardized clinical method.
Time frame: Baseline, 3 months, 6 months, and 12 months
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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Clinical Attachment Level
Clinical attachment level will be calculated in millimeters as probing depth plus gingival recession depth.
Time frame: Baseline, 3 months, 6 months, and 12 months
Percentage of Root Coverage
Percentage of root coverage will be calculated based on the reduction in gingival recession depth from baseline to 12 months.
Time frame: 3 months, 6 months, and 12 months
Complete Root Coverage
Complete root coverage will be defined as the absence of residual gingival recession at the treated site.
Time frame: 3 months, 6 months, and 12 months
Dentin Hypersensitivity
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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient-Reported Esthetic Satisfaction
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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Digital Volumetric Changes
Soft tissue volumetric changes will be assessed using intraoral scans and digital superimposition of three-dimensional Standard Tessellation Language (STL) models.
Time frame: Baseline, 3 months, 6 months, and 12 months
Early Wound Healing
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.
Time frame: 7 days, 14 days, and 30 days
Plan to share: No — Individual participant data will not be shared because the study involves clinical data, photographs, and intraoral scans that may increase the risk of participant identification. Results will be reported in aggregate form.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2028, 23 months after the start.
Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 23 months is above that.
Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.