Department of Periodontology
Bern, 3010, Switzerland
Location status: Recruiting
Location contact
Anton Sculean, Prof
CONTACT
Nikolaos Pandis, PhD
CONTACT
NCT Number: NCT07437417
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
Anton Sculean, Prof
CONTACT
Nikolaos Pandis, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The volume stable collagen matrix will be used together with the modified coronally advanced tunnel technique to cover the gingival recession defect.
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
Time frame: 1 year
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: 2 days until 1 week postoperatively
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: 1 year
Tissue thickness will be calculated by comparing oral scans at baseline and at 1 year by superimposition
Time frame: 1 year
Measured in mm: Clinical attachment level is probing depth plus gingival recession from the cemento-enamel junction.
Time frame: 1 year
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
VAS (score from 1 to 10, with higher scores indicating more satisfaction)
Time frame: 1 week
Pain (VAS score 1-10: a higher score indicates a more painful healing
Contact information is provided by the study sponsor or research team.
Anton Sculean, Prof
CONTACT
Nikolaos Pandis
CONTACT
University of Bern
Other
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
Acronym: FibroGide
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