Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Coronally advanced flap (CAF)
- Conditions
- Gingival Recession
- Sponsor
- University of Sao Paulo
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Percentage of root coverage (RC)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.
Investigators
Giuseppe Alexandre Romito
Chairperson, Department of Periodontics
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •The patients will be included in the study if they fulfill the following inclusion criteria:
- •a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
- •areas of Miller's Class I or II GR;
- •teeth without root abrasions or caries.
Exclusion Criteria
- •The exclusion criteria used will be as follows:
- •patients allergic to collagen
- •a history of smoking (within the previous 6 months)
- •pregnancy or lactation
- •a history of destructive periodontal disease or the formation of recurrent abscesses
- •root caries at the site of recession
- •previous surgical root coverage procedures
- •systemic healing disorders (for example, acquired immunodeficiency syndrome \[AIDS\], diabetes mellitus or risk factors evaluated by a medical doctor)
- •periodontal disease, or poor plaque control (full mouth plaque index \> 20%).
- •The exclusion criteria for teeth will be:
Arms & Interventions
Collagen Matrix plus coronally advanced flap (CAF)
A new collagen matrix (Mucograft) associated to coronally advanced flap
Intervention: Coronally advanced flap (CAF)
Collagen Matrix plus coronally advanced flap (CAF)
A new collagen matrix (Mucograft) associated to coronally advanced flap
Intervention: Collagen Matrix
Subepithelial connective tissue graft plus CAF
Subepithelial connective tissue graft associated to coronally advanced flap
Intervention: Coronally advanced flap (CAF)
Subepithelial connective tissue graft plus CAF
Subepithelial connective tissue graft associated to coronally advanced flap
Intervention: Subepithelial connective tissue graft
Outcomes
Primary Outcomes
Percentage of root coverage (RC)
Time Frame: 12-months
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
Secondary Outcomes
- Reductions in recession depth (RRD)(At the baseline, 3-month, 6-month and 12-months)
- Complete root coverage of the gingival recessions (CRC)(At the baseline, 3-month, 6-month and 12-months)
- Recession width (RW) at the cemento-enamel junction(At the baseline, 3-month, 6-month and 12-months)
- Relative clinical attachment level (RCAL)(At the baseline, 3-month, 6-month and 12-months)
- Probing depth (PD)(At the baseline, 3-month, 6-month and 12-months)
- keratinized tissue width (KT)(At the baseline, 3-month, 6-month and 12-months)
- Gain in thickness of gingival tissue (GT)(At the baseline, 3-month, 6-month and 12-months)