Treatment of Multiple Gingival Recessions (3DMUCO)

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Procedure: Subepithelial connective tissue graft; Procedure: Coronally advanced flap (CAF); Drug: Collagen Matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT02818855

3DMUCO

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The patients will be included in the study if they fulfill the following inclusion criteria:

  1. a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
  2. areas of Miller's Class I or II GR;
  3. 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:

1. noncarious cervical lesions (erosion, abfraction etc.)
2. any type of previous cervical restoration
3. extrusion
4. giroversion
5. mobility
6. a prominent root surface.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

15 participants in 2 patient groups

Collagen Matrix plus coronally advanced flap (CAF)

Experimental group

Description:

A new collagen matrix (Mucograft) associated to coronally advanced flap

Treatment:

Drug: Collagen Matrix

Procedure: Coronally advanced flap (CAF)

Subepithelial connective tissue graft plus CAF

Active Comparator group

Description:

Subepithelial connective tissue graft associated to coronally advanced flap

Treatment:

Procedure: Coronally advanced flap (CAF)

Procedure: Subepithelial connective tissue graft