A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth

NCT07437417 | Recruiting

• 1 other identifier: FibroGide
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal health and preservation of the dentition without tooth loss are important quality of life components and should be safeguarded in order to provide optimal function and esthetics. Optimal treatment of gingiva recessions is likely to allow for more efficient use of healthcare resources and reduced costs long-term. It is evident that the prevalence in gingival recession is high and its consequences on the aging population constitute an important healthcare issue that requires further attention. The standard therapy of gingival recession encompasses a coronally advanced flap or coronally advanced tunnel flap and a connective tissue graft from the palate. Harvesting of the palatal graft involves a second surgical site and increased morbidity for the patients.This project aims to compare the connective tissue graft against a novel volume stable collagen matrix. Patients will be treated according to standard protocols of the Department of Periodontology. In the test group patient will undergo tissue thickening with a collagen matrix and the modified coronally advanced tunnel technique. The control group will undergo the standard protocol using a connective tissue graft from the palate along with the modified coronally advanced tunnel technique. No study specific risks do exist.

Conditions

Gingival Recession; Connective Tissue Defect

Keywords

Connective tissue graft; Collagen Matrix; single and multiple gingival recessions

Outcome Measures

Primary Outcomes (1)

• Mean root coverage

  Mean root coverage in % will be measured in mm from the cemento-enamel junction to the margo gingivae and expressed as a percentage of the baseline gingival recession

  1 year

Secondary Outcomes (6)

• Early wound healing index score

  2 days until 1 week postoperatively

• Tissue thickness increase

  1 year

• Clinical attachment level

  1 year

• Recession coverage aesthetic score (score 1-10)

  1 year

• Patient-centered outcomes (esthetics)

  1 year

Study Arms (2)

Fibrogide test

EXPERIMENTAL

A volume stable collagen matrix will be used instead of a connective tissue graft. A modified coronally advanced tunnel flap will first be prepared, then the collagen matrix will be inserted and the flap coronally sutured.

Procedure: Volume stable collagen matrix

CTG control

ACTIVE COMPARATOR

A connective tissue graft will be harvested from the palate. A modified coronally advanced tunnel flap will first be prepared, then the connective tissue graft will be inserted and the flap coronally sutured.

Procedure: Control

Interventions

Volume stable collagen matrix PROCEDURE

The volume stable collagen matrix will be used together with the modified coronally advanced tunnel technique to cover the gingival recession defect.

Fibrogide test

Control PROCEDURE

A connective tissue harvested from the palate will be used for tissue augmentation together with the modified coronally advanced tunnel technique to cover the gingival recession defect.

Also known as: Connective tissue

CTG control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Healthy patients referred to the clinic for recession coverage
• Miller Class I, II or III facial gingival recession (GR) defect, \>3 mm, located on the buccal of the maxillary or mandibular canine and incisor area.

You may not qualify if:

• History of diseases with hypocoagulability, instable diabetes mellitus, post-irradiation in the head and neck area, infectious diseases or heart diseases that need prophylactic antibiosis before dental treatments or a medication with effect on the gingiva: Ciclosporin A, compounds of Phenytoin, calcium channel blockers, pregnant or breastfeeding patients

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Anton Sculean, Prof

  University of Bern

  STUDY CHAIR

Central Study Contacts

Anton Sculean, Prof

CONTACT

+41 31 684 06 20; anton.sculean@unibe.ch

Nikolaos Pandis

CONTACT

+41 31 684 06 40; nikolaos.pandis@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, controlled, clinical trial

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 27, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)