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

Phase 4

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Microsurgery technique for root coverage; Biological: Microsurgery technique for root coverage associated to EMD

• Registration Number: NCT03059966
• Lead Sponsor: Rio de Janeiro State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-01-19
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Bilateral gingival recessions in homologous teeth

Exclusion Criteria

• Smokers;
• Systemic diseases;
• Drugs affecting periodontal health/healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Microsurgery technique for root coverage	Microsurgery for root coverage associated with a Placebo comparator
Enamel Matrix Derivative	Microsurgery technique for root coverage associated to EMD	Microsurgery for root coverage associated with Enamel Matrix Derivative

Primary Outcome Measures

Name	Time	Method
Post-surgical pain	7 days after surgery	Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
Root Coverage Score	180 days after surgery	A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)
Post-surgical Clinical Analysis	180 days after surgery	Analysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.
Changes in Gingival Fluid Biomarkers	Baseline, 7 and 14 days after surgery	Analysis for 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 by Luminex