Gingival RecessionVCMX-SCTGNCT07613775
Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions
A study testing Volume-stable xenogeneic collagen matrix (VCMX) and Subepithelial connective tissue graft (SCTG) in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Volume-stable xenogeneic collagen matrix (VCMX) and Subepithelial connective tissue graft (SCTG)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arthur Belem Novaes Jr, DDS, PhD contact
Brazil1 site
School of Dentistry of Ribeirão Preto, University of Sao Paulo
Ribeirão Preto, São Paulo, 14040-904
Edgar Daniel Vargas Quiroga, DDS, MSc, +551633153000, edgar.vargasquiroga@usp.br
Arthur Belem Novaes Jr, DDS, PhD, novaesjr@forp.usp.br
About this study
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
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 detailed 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.
- Conditions
- Gingival Recession
- Being tested
- Volume-stable xenogeneic collagen matrix (VCMX), Subepithelial connective tissue graft (SCTG)
- Keywords
- Multiple Gingival Recessions, Volume-Stable Collagen Matrix, Subepithelial Connective Tissue Graft, Coronally Advanced Flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-stable xenogeneic collagen matrix (VCMX)Device
Also called VCMX, Fibro-Gide
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 or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Volume-Stable Collagen Matrix | Experimental | Participants in this group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. Receives: Device: Volume-stable xenogeneic collagen matrix (VCMX) |
| Subepithelial Connective Tissue Graft | Active comparator | Participants in this group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap. Receives: Procedure: Subepithelial connective tissue graft (SCTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes (11)
Gingival Recession Width
Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days, 14 days, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups. The test group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. The control group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
- Investigators
- Arthur Belem Novaes Jr, DDS, PhD, Principal investigator, University of Sao PauloEdgar Daniel Vargas Quiroga, DDS, MSc, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613775
- Sponsor's protocol ID
- CAAE 98199226.9.0000.5419
- Other IDs
- CAAE 98199226.9.0000.5419
- Acronym
- VCMX-SCTG
- Status last verified
- Aug 2026
- First submitted
- 21 May 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07613775
- Acronym / sponsor ID
- VCMX-SCTG / CAAE 98199226.9.0000.5419
- Conditions
- Gingival Recession
- Keywords
- Multiple Gingival Recessions, Volume-Stable Collagen Matrix, Subepithelial Connective Tissue Graft, Coronally Advanced Flap
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups. The test group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. The control group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
| Arm | Type | Receives |
|---|---|---|
| Volume-Stable Collagen Matrix | Experimental | Device: Volume-stable xenogeneic collagen matrix (VCMX)Participants in this group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. |
| Subepithelial Connective Tissue Graft | Active comparator | Procedure: Subepithelial connective tissue graft (SCTG)Participants in this group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-stable xenogeneic collagen matrix (VCMX)Also: VCMX, Fibro-GideA 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. | Device | Volume-Stable Collagen Matrix |
| Subepithelial connective tissue graft (SCTG)Also: SCTGAn 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. | Procedure or surgery | Subepithelial Connective Tissue Graft |
Primary outcome
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.
11 secondary outcomes
Gingival Recession Width
Time frame: Baseline, 3 months, 6 months, and 12 months
Keratinized Tissue Width
Time frame: Baseline, 3 months, 6 months, and 12 months
Gingival Thickness
Time frame: Baseline, 3 months, 6 months, and 12 months
Probing Depth
Time frame: Baseline, 3 months, 6 months, and 12 months
Clinical Attachment Level
Time frame: Baseline, 3 months, 6 months, and 12 months
Percentage of Root Coverage
Time frame: 3 months, 6 months, and 12 months
Complete Root Coverage
Time frame: 3 months, 6 months, and 12 months
Dentin Hypersensitivity
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient-Reported Esthetic Satisfaction
Time frame: Baseline, 3 months, 6 months, and 12 months
Digital Volumetric Changes
Time frame: Baseline, 3 months, 6 months, and 12 months
Early Wound Healing
Time frame: 7 days, 14 days, and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: 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.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Belem Novaes Jr, DDS, PhD contact
Arthur Belem Novaes Jr, DDS, PhD principal investigator
University of Sao Paulo
Edgar Daniel Vargas Quiroga, DDS, MSc study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume-stable xenogeneic collagen matrix (VCMX) and Subepithelial connective tissue graft (SCTG) in people with Gingival Recession, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edgar Daniel Vargas Quiroga, DDS, MSc (+551633153000, edgar.vargasquiroga@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Recession Depth (time frame: Baseline, 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.