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RecruitingNCT07437417FibroGideUpdated Feb 27, 2026

A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth

An interventional study of Volume stable collagen matrix and Control in Gingival Recession and Connective Tissue Defect, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2025, registered Jan 2026).
  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gingival Recession
  • Connective Tissue Defect

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Keywords

  • Connective tissue graft
  • Collagen Matrix
  • single and multiple gingival recessions
03

In context

Gingival Recession

402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's planned enrollment of 60 is above the median of 30 across 368 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureVolume 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.

  • ProcedureControl

    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

06

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

  1. 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)

    Time frame: 2 days until 1 week postoperatively

  2. Tissue thickness increase

    Tissue thickness will be calculated by comparing oral scans at baseline and at 1 year by superimposition

    Time frame: 1 year

  3. Clinical attachment level

    Measured in mm: Clinical attachment level is probing depth plus gingival recession from the cemento-enamel junction.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

  5. Patient-centered outcomes (esthetics)

    VAS (score from 1 to 10, with higher scores indicating more satisfaction)

    Time frame: 1 year

  6. Patient-satisfaction (VAS score 1-10)

    Pain (VAS score 1-10: a higher score indicates a more painful healing

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07437417
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Sep 1, 2025
Primary completion
Sep 1, 2029 (estimated)
Completion
Aug 1, 2030 (estimated)
Last update
Feb 27, 2026

Study contacts

Anton Sculean, Prof
Contact
anton.sculean@unibe.ch
+41 31 684 06 20
Nikolaos Pandis
Contact
nikolaos.pandis@unibe.ch
+41 31 684 06 40
Anton Sculean, Prof
study chair · University of Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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