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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Department of Periodontology
Bern, Switzerland
Start Date
September 1, 2025
Primary Completion Date
September 1, 2029
Completion Date
August 1, 2030
Last Updated
February 27, 2026
60
ESTIMATED participants
Volume stable collagen matrix
PROCEDURE
Control
PROCEDURE
Lead Sponsor
University of Bern
NCT07200258
NCT07158541
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT06409468