drugset / Trial / NCT02818855

Treatment of Multiple Gingival Recessions

NCT02818855 ↗

Phase 4 Completed 15 enrolled University of Sao Paulo
RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start
2014-03
Primary completion
2015-10
Completion
2016-04

Outcome

Missed primary endpoint

paper RESULTS: At 6 months, root coverage (primary outcome) was 75.29% for test and 72.66% for control defects (p = 0.169) PMID 23050490 ↗

paper CONCLUSIONS: CAF + CM was not superior with regard to root coverage PMID 23050490 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagen Matrix Protein / enzyme biologic — —

Indications