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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Biological: Microsurgery technique for root coverage associated to EMD; Procedure: Microsurgery technique for root coverage

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bilateral gingival recessions in homologous teeth

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enamel Matrix Derivative; Microsurgery for root coverage associated with Enamel Matrix Derivative	Biological: Microsurgery technique for root coverage associated to EMD; Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative
Placebo Comparator: Placebo; Microsurgery for root coverage associated with a Placebo comparator	Procedure: Microsurgery technique for root coverage; Microsurgery technique for root coverage adapted for macrosurgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 285.706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No