Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix (EmdoDerm)

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Use of coronally advanced flap (CAF) and collagen matrix (CM); Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
• extruded or malpositioned teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CAF + CM; Coronally advanced flap (CAF) and collagen matrix (CM)	Device: Use of coronally advanced flap (CAF) and collagen matrix (CM)
Experimental: CAF + CM +EMD; Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).	Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival recession height	Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin	12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Width of keratinized tissue (WKT)	Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction	12 months postoperatively
pocket probing depth (PPD)	Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus	12 months postoperatively
Clinical attachment loss (CAL)	Clinical attachment loss in millimeters	12 months postoperatively

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: collagen; gingival recession; coronally advanced flap; enamel matrix protein; dental enamel protein; periodontal plastic surgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: EmdoDerm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No