NCT Number: NCT07613775
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14040-904, Brazil
Arthur Belem Novaes Jr, DDS, PhD
CONTACT
Arthur Belem Novaes Jr, DDS, PhD
PRINCIPAL_INVESTIGATOR
Edgar Daniel Vargas Quiroga, DDS, MSc
CONTACT
Edgar Daniel Vargas Quiroga, DDS, MSc
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Arthur Belem Novaes Jr, DDS, PhD
CONTACT
Edgar Daniel Vargas Quiroga, DDS, MSc
CONTACT
University of Sao Paulo
Other
Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial
Acronym: VCMX-SCTG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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