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

NCT ID: NCT03059966

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enamel Matrix Derivative

Microsurgery for root coverage associated with Enamel Matrix Derivative

Group Type: EXPERIMENTAL

Microsurgery technique for root coverage associated to EMD

Intervention Type: BIOLOGICAL

Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative

Placebo

Microsurgery for root coverage associated with a Placebo comparator

Group Type: PLACEBO_COMPARATOR

Microsurgery technique for root coverage

Intervention Type: PROCEDURE

Microsurgery technique for root coverage adapted for macrosurgery

Interventions

Microsurgery technique for root coverage

Microsurgery technique for root coverage adapted for macrosurgery

Intervention Type: PROCEDURE

Microsurgery technique for root coverage associated to EMD

Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Bilateral gingival recessions in homologous teeth

Exclusion Criteria

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

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 53 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Tavares Dias

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

285.706

Identifier Type: -

Identifier Source: org_study_id