Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions (VCMX-SCTG)

May 21, 2026 updated by: Arthur Belem Novaes Jr, University of Sao Paulo

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14040-904
        • School of Dentistry of Ribeirão Preto, University of Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arthur Belem Novaes Jr, DDS, PhD
        • Sub-Investigator:
          • Edgar Daniel Vargas Quiroga, DDS, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • VCMX
  • Fibro-Gide
Active Comparator: 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
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.
Other Names:
  • SCTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, and 12 months
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.
Baseline, 3 months, 6 months, and 12 months
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.
Baseline, 3 months, 6 months, and 12 months
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.
Baseline, 3 months, 6 months, and 12 months
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.
Baseline, 3 months, 6 months, and 12 months
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.
3 months, 6 months, and 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.
3 months, 6 months, and 12 months
Dentin Hypersensitivity
Time Frame: Baseline, 3 months, 6 months, and 12 months
Dentin hypersensitivity will be assessed using a visual analog scale after standardized air stimulation of the treated teeth.
Baseline, 3 months, 6 months, and 12 months
Patient-Reported Esthetic Satisfaction
Time Frame: Baseline, 3 months, 6 months, and 12 months
Patient-reported esthetic satisfaction with the treatment outcome will be assessed using a visual analog scale.
Baseline, 3 months, 6 months, and 12 months
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 STL models.
Baseline, 3 months, 6 months, and 12 months
Early Wound Healing
Time Frame: 7 days, 14 days, and 30 days
Early wound healing will be assessed clinically during the postoperative period using a standardized wound healing index.
7 days, 14 days, and 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Arthur Belem Novaes Jr, DDS, PhD, University of Sao Paulo
  • Study Chair: Edgar Daniel Vargas Quiroga, DDS, MSc, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 98199226.9.0000.5419 (Other Identifier: Plataforma Brasil / Brazilian CEP-CONEP System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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