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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059966
• Other study ID #: 285.706
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2017
• Last updated: February 16, 2017
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Years to 53 Years

Eligibility

Inclusion Criteria:

• Bilateral gingival recessions in homologous teeth

Exclusion Criteria:

• Smokers;

• Systemic diseases;

• Drugs affecting periodontal health/healing.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Microsurgery technique for root coverage
Microsurgery technique for root coverage adapted for macrosurgery

Biological:
• Microsurgery technique for root coverage associated to EMD
Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-surgical pain	Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)	7 days after surgery
Primary	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
Primary	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
Primary	Changes in Gingival Fluid Biomarkers	Analysis for IL-1ß, 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-a e VEGF by Luminex	Baseline, 7 and 14 days after surgery