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

Rio de Janeiro State University

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Biological: Microsurgery technique for root coverage associated to EMD; Procedure: Microsurgery technique for root coverage

Study type: Interventional

Funder types: Other

Identifiers

NCT03059966

285.706

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 29 to 53 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Bilateral gingival recessions in homologous teeth

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups, including a placebo group

Enamel Matrix Derivative

Experimental group

Description:

Microsurgery for root coverage associated with Enamel Matrix Derivative

Treatment:

Biological: Microsurgery technique for root coverage associated to EMD

Placebo

Placebo Comparator group

Description:

Microsurgery for root coverage associated with a Placebo comparator

Treatment:

Procedure: Microsurgery technique for root coverage