Gingival Recession, Generalized
Conditions
Keywords
Gingival Recession, Collagen Matrix, Periodontics
Brief summary
Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).
Detailed description
Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.
Interventions
PROCEDURERoot coverage surgery
Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM
Sponsors
Geistlich Pharma AG
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine); * Miller class I and II gingival recession areas * Non-abrasive, erosive, or carious root surfaces * Unrotated, non-extruded, and non-movable teeth * Systemically healthy patients without contraindication to periodontal surgical procedures
Exclusion criteria
* Smokers * Pregnant women and infants * Patients with a history of periodontal disease or recurrent abscess formation * Patients previously submitted to surgical procedures for root coverage * Patients taking anti-convulsant drugs * Antihypertensives, contraceptives or immunosuppressors * Patients with low oral hygiene (plaque and bleeding index over 20%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival recession depth (GRD) | one year | Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized mucosa width | year | Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width \> 5mm |
| Dentin hypersensitivity | year | Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complete root coverage | year | Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ) |
| Soft tissue thickness (STT) | year | Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter |
| Probing Depth (PD) | year | Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal) |
| Clinical attachment level loss (CAL) | year | Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal) |
Countries
Brazil
Outcome results
None listed