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

NCT ID: NCT05799859

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-09
• Study Completion Date: 2022-09-22

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.

Conditions

Gingival Recession

Study Design

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

Study Groups

CAF + CM

Coronally advanced flap (CAF) and collagen matrix (CM)

Group Type: ACTIVE_COMPARATOR

Use of coronally advanced flap (CAF) and collagen matrix (CM)

Intervention Type: DEVICE

CAF + CM +EMD

Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

Group Type: EXPERIMENTAL

Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

Intervention Type: DEVICE

Interventions

Use of coronally advanced flap (CAF) and collagen matrix (CM)

Intervention Type: DEVICE

Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

Intervention Type: DEVICE

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;
• extruded or malpositioned teeth.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EmdoDerm

Identifier Type: -

Identifier Source: org_study_id