NCT03059966

Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rio de Janeiro State University · Academic / Other
• Sex: All
• Age: 29 Years – 53 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was the evaluation of inflammatory and healing profile after root coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root coverage surgery with subepithelial connective tissue graft, with and without enamel matrix derivative. The patient screening was based in the following inclusion criteria: bilateral recessions in maxillary anterior homologous teeth with aesthetical complaining ou hypersensitivity, non-smokers, healthy and no use of any medication that compromises periodontal health or healing. The split-mouth randomized model was followed in relation to test and control sites. The following clinical parameters were analyzed at baseline and 6-month post-surgery: recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness. In addition to the surgical analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These evaluations were performed at baseline, 7 and 14 days after surgery.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
PROCEDURE	Microsurgery technique for root coverage	Microsurgery technique for root coverage adapted for macrosurgery
BIOLOGICAL	Microsurgery technique for root coverage associated to EMD	Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-02-23
• Last updated: 2017-02-23

Regulatory

• FDA-regulated drug study