Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions

NCT07613775 | Not Yet Recruiting

• 1 other identifier: CAAE 98199226.9.0000.5419
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gingival Recession

Keywords

Multiple Gingival Recessions; Volume-Stable Collagen Matrix; Subepithelial Connective Tissue Graft; Coronally Advanced Flap

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months, 6 months, and 12 months

Secondary Outcomes (11)

• Gingival Recession Width

  Baseline, 3 months, 6 months, and 12 months

• Keratinized Tissue Width

  Baseline, 3 months, 6 months, and 12 months

• Gingival Thickness

  Baseline, 3 months, 6 months, and 12 months

• Probing Depth

  Baseline, 3 months, 6 months, and 12 months

• Clinical Attachment Level

  Baseline, 3 months, 6 months, and 12 months

Study Arms (2)

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.

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.

Procedure: Subepithelial connective tissue graft (SCTG)

Interventions

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.

Also known as: VCMX, Fibro-Gide

Volume-Stable Collagen Matrix

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.

Also known as: SCTG

Subepithelial Connective Tissue Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirão Preto, University of Sao Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Arthur Belem Novaes Jr, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Edgar Daniel Vargas Quiroga, DDS, MSc

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Edgar Daniel Vargas Quiroga, DDS, MSc

CONTACT

+551633153000; edgar.vargasquiroga@usp.br

Arthur Belem Novaes Jr, DDS, PhD

CONTACT

novaesjr@forp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical examiner and the assessors responsible for photographic and digital outcome analyses will be masked to treatment allocation. The surgeon will not be masked because of the nature of the procedures. Participants will not be masked because the control group involves palatal tissue harvesting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)