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

30. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Brasilien
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14040-904
        • School of Dentistry of Ribeirão Preto, University of Sao Paulo
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Arthur Belem Novaes Jr, DDS, PhD
        • Underforsker:
          • Edgar Daniel Vargas Quiroga, DDS, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Volume-stable xenogeneic collagen matrix (VCMX)
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.
Andre navne:
  • VCMX
  • Fibro-Gide
Aktiv komparator: 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 (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.
Andre navne:
  • SCTG

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gingival Recession Depth
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gingival Recession Width
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Baseline, 3 months, 6 months, and 12 months
Patient-Reported Esthetic Satisfaction
Tidsramme: 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.
Baseline, 3 months, 6 months, and 12 months
Digital Volumetric Changes
Tidsramme: 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.
Baseline, 3 months, 6 months, and 12 months
Early Wound Healing
Tidsramme: 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.
7 days, 14 days, and 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Efterforskere

  • Ledende efterforsker: Arthur Belem Novaes Jr, DDS, PhD, University of Sao Paulo
  • Studiestol: Edgar Daniel Vargas Quiroga, DDS, MSc, University of Sao Paulo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAAE 98199226.9.0000.5419 (Anden identifikator: Plataforma Brasil / Brazilian CEP-CONEP System)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

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