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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Microsurgery technique for root coverage
* Biological: Microsurgery technique for root coverage associated to EMD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral gingival recessions in homologous teeth Exclusion Criteria: Smokers; Systemic diseases; Drugs affecting periodontal health/healing.

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |