drugset / Trial / NCT02135471

Root Coverage in Smokers With Acellular Dermal Matrix Graft and Enamel Matrix Derivative

NCT02135471

Phase 2 Completed 19 enrolled University of Sao Paulo
RandomizedCrossoverSingle-blindTreatment

Summary

Smoking has a negative effect on the predictability and stability of root coverage procedures because of decreased blood supply and fibroblast activity. Long-term evaluation of this procedure in smokers is important for clinical decision making, because it provides information about the stability of results over time. In smokers, enamel matrix derivative (EMD) used at acellular dermal matrix graft (ADMG)/ soft tissue interface could be an alternative to improve the deficient healing potential, since EMD has the capability of stimulating angiogenesis. At the ADMG/ root surface interface, it could improve the deficient fibroblast activity in smokers and therefore reduce the presence of a long junctional epithelium. The aim of this randomised controlled clinical study was to investigate whether EMD contributes to the root coverage of gingival recessions performed with ADMG in smokers during a 12-month follow-up. Twenty smokers with bilateral Miller Class I or II gingival recessions ≥ 3 mm will be selected. The test group will be treated with an association of ADMG and EMD, and the control group with ADMG alone. Some clinical parameters as: probing depth, relative clinical attachment level, gingival recession height, gingival recession width, keratinized tissue width and keratinized tissue thickness will be evaluated before surgery and after twelve months.

Timeline

Start
2009-06
Primary completion
2011-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject enamel matrix derivative Protein / enzyme biologic
Background AlloDerm Other / unclassified

Indications