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

NCT07083050 | Recruiting

• 1 other identifier: Fibroguide
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Gingival recession; Root coverage; Collagen Construct; Connective tissue graft; Morbidity

Outcome Measures

Primary Outcomes (1)

• Root coverage

  Difference in reduction in gingival recession (root coverage) between baseline and 12 months

  12 months

Secondary Outcomes (3)

• Complete root coverage

  12 months

• Time to recovery

  The first two post-operative weeks

• Oral Health Related Quality of Life

  3, 6, 12, 24, and 36 months

Other Outcomes (1)

• Tissue thickness

  6 and 12 months

Study Arms (2)

Coronally Advanced Flap plus Collagen Matrix

EXPERIMENTAL

Coronally Advanced Flap plus Collagen Matrix Tissue Substitute

Device: Volume stable collagen matrix

Coronally Advanced Flap plus Autologous Connective Tissue Graft

ACTIVE COMPARATOR

Current standard of care

Procedure: Autologous Connective Tissue Graft from the Hard Palate

Interventions

Volume stable collagen matrix DEVICE

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

Also known as: Fibrogide

Coronally Advanced Flap plus Collagen Matrix

Autologous Connective Tissue Graft from the Hard Palate PROCEDURE

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

Also known as: CTG

Coronally Advanced Flap plus Autologous Connective Tissue Graft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, 18 to 70 years of age, with a minimum of two adjacent teeth with gingival recession (at least one with a depth ≥ 3 mm - RT1 or RT2 with 2 mm or less of interdental periodontal attachment loss) in anterior and premolar teeth in the maxilla and requiring surgical intervention, without medical contraindications to elective surgery. In case of recessions on five or more adjacent teeth, the teeth at the external sides will not be included in the study.
• At least 2 mm marginal keratinized tissue width and irrespective of soft tissue thickness prior therapy. The study should involve treatment naïve patients in terms of root coverage procedures. Prior therapy should include treatment of gingival inflammation, if present, instructions in non-traumatic oral hygiene, and reconstruction of the cemento-enamel junction with adhesive dental materials in case of cervical abrasion or erosion involving this structure
• Evidence of subject ability to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS\<25% and FMBS\<25%)
• Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.

You may not qualify if:

• Presence of untreated periodontitis
• Persistence of uncorrected gingival trauma from tooth brushing
• Interdental attachment loss greater than 2 mm or furcation involvement in the experimental teeth
• Presence of less than 2 mm of keratinized tissue width
• Presence of severe tooth malposition, rotation or clinically significant super-eruption
• Self reported current smoking exceeding 10 cigarettes/day or pipe or cigar smoking
• Rheumatoid arthritis or known sensitization to collagen based medical products.
• Presence of medical contraindications to elective surgery
• Participation in another interventional clinical trial
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of individual to give written informed consent.
• Uncontrolled diabetes mellitus
• Allergy to collagen
• Pregnancy or lactation or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control (e.g., oral or parenteral contraceptives, diaphragm plus spermicide, condoms).
• Radiotherapy

Sponsors & Collaborators

• Maurizio Tonetti: lead
• University of Florence: collaborator
• Universitat Internacional de Catalunya: collaborator

Study Sites (2)

Ospedale Careggi

Florence, Italy

RECRUITING

International University of Catalunya

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Maurizio Tonetti, DMD PhD

  The European Research Group on Periodontology (ERGOPerio)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Tonetti, DMD, PhD

CONTACT

393473289709; maurizio.tonetti@ergoperio.eu

Luigi Barbato, DMD, PhD

CONTACT

39-3299457556; luigi.barbato@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 12, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

IT (1); ES (1)