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Non-Inferiority of Fibroguide Collagen Membrane Compared to Autologous Connective Tissue Graft for Coverage of Multiple Adjacent Recession. Multicenter Trial.

NCT07083050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-07

No results posted yet for this study

Summary

This study deals with coverage of multiple denuded roots. The current standard treatment requires surgical correction and uses soft tissue taken from the roof of the mouth to enhance results. The hypothesis of this trial is that a synthetic collagen matrix (called Fibrogide) can be used to replace soft tissue taken from the subject. If the collagen matrix will prove to be equally as effective as the patient own tissue, it will be possible to avoid a more extensive surgery and decrease pain and discomfort.

Conditions

  • Gingival Recession, Plastic Surgery

Interventions

DEVICE

Volume stable collagen matrix

Volume stable collagen matrix obtained from porcine collagen after proprietary cross-linking by device manufacturer

PROCEDURE

Autologous Connective Tissue Graft from the Hard Palate

Autologous connective tissue surgically harvested from the hard palate and transplanted in the area of gingival recession

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • Universitat Internacional de Catalunya

    collaborator OTHER

  • Maurizio Tonetti

    lead NETWORK

Principal Investigators

  • Maurizio Tonetti, DMD PhD · The European Research Group on Periodontology (ERGOPerio)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-12
Primary Completion
2026-12-31
Completion
2029-12-31

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083050 on ClinicalTrials.gov