A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth (FibroGide)

Assessment of Connective Tissue Graft vs. a New Collagen Matrix for Periodontal Tissue Thickening and Coverage of Single or Multiple Adjacent Gingival Recessions of Orthodontically Treated Patients. A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession; Connective Tissue Defect
• Intervention / Treatment: Procedure: Volume stable collagen matrix; Procedure: Control

Detailed Description

Background: Gingival recessions constitute a common problem in the adult population worldwide. In the United States the prevalence of ≥1 mm recession in persons >30 years was 58%, representing over 60 million adults while in a French cohort aged 30-65 years old 84.6% had at least one gingival recession. In two other studies it has been reported that over 90% of adults aged 35 or 50 years and above, respectively, present with single or multiple gingival recessions. The consequences of gingival recessions can be gingivitis due to suboptimal oral hygiene, tooth mobility and in extreme circumstances tooth loss5. Tooth sensitivity, root caries, non-carious cervical lesions and esthetic concerns especially with anteriorly located recessions can be also encountered. Gingival recessions have been associated with a number of factors such as age, gender, smoking; poor self-reported oral hygiene, history of periodontal treatment, supragingival calculus, trauma, parafunctional activity, anatomy, smoking, piercing and orthodontic therapy in adolescents and adults. With the yearly increase in the number of orthodontic patients a potentially additional burden is expected in the population. Treatment modalities initially aimed to increase the apico-coronal width and thickness of keratinized tissue in order to stabilize the gingival margin level and to enable better oral hygiene. Subsequently, periodontal health, aesthetics and root coverage were the focus of treatment. Several surgical procedures have been proposed in recent decades for the treatment of gingival recessions alone or combined with autografts or allografts. The majority of the existing evidence deals with gingival recessions in the maxilla with limited emphasis to patient important outcomes.

Aim: To evaluate the use of connective tissue grafts vs. a new collagen matrix (Fibrogide) in terms of effectiveness for root coverage, early wound healing and for periodontal tissue thickening of isolated and multiple adjacent Miller Class I, II and III gingival recessions in orthodontically treated patients.

Significance: 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. It is important to clarify that the published trials deal mainly with the upper jaw and that the applicability of the results to the lower jaw due to lack of trials and the anatomic nuances of the area is uncertain. There is a need to address optimal treatment procedures in the upper and lower jaw as this is the area where the consequences of gingival recessions due to, mainly, difficulties in maintaining optimal oral hygiene can have the greatest health impact. This project aims to expand our knowledge on the field by assessing which treatment modalities can best treat gingival recessions and also result in the best patient important outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anton Sculean, Prof; Phone Number: +41 31 684 06 20; Email: anton.sculean@unibe.ch
• Study Contact Backup: Name: Nikolaos Pandis; Phone Number: +41 31 684 06 40; Email: nikolaos.pandis@unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Periodontology
    • Contact: Anton Sculean, Prof; Phone Number: +41316840620; Email: anton.sculean@unibe.ch
    • Contact: Nikolaos Pandis, PhD; Phone Number: +41316840640; Email: nikolaos.pandis@unibe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibrogide test; 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; The volume stable collagen matrix will be used together with the modified coronally advanced tunnel technique to cover the gingival recession defect.
Active Comparator: CTG control; 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; 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.; Other Names: Connective tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early wound healing index score	Measured by the Early wound healing score from 0-3 (higher scores indicating worse healing outcomes). The score combines flap closure, fibrin coverage, and suppuration (composite endpoint)	2 days until 1 week postoperatively
Tissue thickness increase	Tissue thickness will be calculated by comparing oral scans at baseline and at 1 year by superimposition	1 year
Clinical attachment level	Measured in mm: Clinical attachment level is probing depth plus gingival recession from the cemento-enamel junction.	1 year
Recession coverage aesthetic score (score 1-10)	A higher score (score from 1-10) indicates a more aesthetic outcome in terms of recession coverage, tissue colour and tissue texture.	1 year
Patient-centered outcomes (esthetics)	VAS (score from 1 to 10, with higher scores indicating more satisfaction)	1 year
Patient-satisfaction (VAS score 1-10)	Pain (VAS score 1-10: a higher score indicates a more painful healing	1 week

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Anton Sculean, Prof, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Connective tissue graft; Collagen Matrix; single and multiple gingival recessions
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: FibroGide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No