A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Volume stable collagen matrix, Control.
- Who it may be relevant to
- Registry conditions: Gingival Recession, Connective Tissue Defect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Procedure Volume 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. - Procedure Control
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.
Primary outcome measures
- Mean root coverage [Time frame: 1 year]
Secondary outcome measures (6)
- Early wound healing index score [Time frame: 2 days until 1 week postoperatively]
- Tissue thickness increase [Time frame: 1 year]
- Clinical attachment level [Time frame: 1 year]
- Recession coverage aesthetic score (score 1-10) [Time frame: 1 year]
- Patient-centered outcomes (esthetics) [Time frame: 1 year]
- Patient-satisfaction (VAS score 1-10) [Time frame: 1 week]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Department of Periodontology — Bern
Identifiers
NCT: NCT07437417 · FibroGide