A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Volume stable collagen matrix
Procedure/SurgeryThe volume stable collagen matrix will be used together with the modified coronally advanced tunnel technique to cover the gingival recession defect.
Control
Procedure/SurgeryA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Fibrogide testExperimental treatment 1 intervention
Group B: CTG controlActive comparator 1 intervention
Trial outcomes
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 yearSecondary 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 postoperatively2
Tissue thickness increase
Tissue thickness will be calculated by comparing oral scans at baseline and at 1 year by superimposition
Time frame
1 year3
Clinical attachment level
Measured in mm: Clinical attachment level is probing depth plus gingival recession from the cemento-enamel junction.
Time frame
1 year4
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 yearSponsors and contacts
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Source ClinicalTrials.gov