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

NCT05799859 | Completed

• 1 other identifier: EmdoDerm
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Recession

Keywords

coronally advanced flap; collagen; enamel matrix protein; dental enamel protein; gingival recession; periodontal plastic surgery

Outcome Measures

Primary Outcomes (1)

• Gingival recession height

  Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin

  12 months postoperatively

Secondary Outcomes (3)

• Width of keratinized tissue (WKT)

  12 months postoperatively

• pocket probing depth (PPD)

  12 months postoperatively

• Clinical attachment loss (CAL)

  12 months postoperatively

Study Arms (2)

CAF + CM

ACTIVE COMPARATOR

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

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

CAF + CM +EMD

EXPERIMENTAL

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).

Interventions

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

CAF + CM

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

CAF + CM +EMD

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: January 9, 2017
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share