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

M

Medical University of Graz

Status

Completed

Conditions

Gingival Recession

Treatments

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).

Study type

Interventional

Funder types

Other

Identifiers

NCT05799859
EmdoDerm

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

CAF + CM
Active Comparator group
Description:
Coronally advanced flap (CAF) and collagen matrix (CM)
Treatment:
Device: Use of coronally advanced flap (CAF) and collagen matrix (CM)
CAF + CM +EMD
Experimental group
Description:
Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Treatment:
Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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