Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial

Medical University of Graz0 sites15 target enrollmentJanuary 9, 2017

ConditionsGingival Recession

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gingival Recession
Sponsor: Medical University of Graz
Enrollment: 15
Primary Endpoint: Gingival recession height
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The clinical trial studies patients with gingival recession defects (receding gums).

The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.

Detailed Description

The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD. In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year. 15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.

Registry

clinicaltrials.gov

Start Date

January 9, 2017

End Date

September 22, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Graz

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent
•able to achieve good oral hygiene (full mouth plaque score \< 20 %, full mouth bleeding score \< 20%),
•patients presenting with at least one gingival recession defect

Exclusion Criteria

•general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);
•ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;
•self-reported heavy smokers (more than 10 cigarettes/day);
•pregnancy and nursing mothers;
•disorders or treatments that impair wound healing;
•long-term treatment with high-dose steroids or anticoagulants;
•bone metabolism disorders;
•infections or vascular disorders in the region to be treated;
•known hypersensitivity to porcine collagen;
•patients with severe peripheral artery disease or autoimmune diseases;