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Gingival RecessionFibroGideNCT07437417

A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth

A study testing Volume stable collagen matrix in people with Gingival Recession and Connective Tissue Defect, run by University of Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession, Connective Tissue Defect
What is being tested?
Volume stable collagen matrix
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2025to 1 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting
  • Department of Periodontology

    Bern, 3010

    Anton Sculean, Prof, +41316840620, anton.sculean@unibe.ch

    Nikolaos Pandis, PhD, +41316840640, nikolaos.pandis@unibe.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

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.

Being tested
Volume stable collagen matrix, Control
Keywords
Connective tissue graft, Collagen Matrix, single and multiple gingival recessions
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volume stable collagen matrixProcedure or surgery

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

  • ControlProcedure or surgery

    Also called Connective tissue

    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.

Study groups in NCT07437417
Study groupRoleWhat they receive
Fibrogide testExperimentalA 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.
Receives: Procedure: Volume stable collagen matrix
CTG controlActive comparatorA 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.
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (6)
  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)

    Measured: 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

    Measured: 1 year

  3. Clinical attachment level

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

    Measured: 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.

    Measured: 1 year

  5. Patient-centered outcomes (esthetics)

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

    Measured: 1 year

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

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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Sep 2025
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomised, controlled, clinical trial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07437417
Sponsor's protocol ID
FibroGide
Acronym
FibroGide
Status last verified
Feb 2026
First submitted
19 Jan 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Volume stable collagen matrix in people with Gingival Recession and Connective Tissue Defect, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anton Sculean, Prof (+41 31 684 06 20, anton.sculean@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean root coverage (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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