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Completed

NCT Number: NCT05799859

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

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.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Device

Primary outcomes

  1. Gingival recession height

    Time frame: 12 months postoperatively

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

Secondary outcomes

  1. Width of keratinized tissue (WKT)

    Time frame: 12 months postoperatively

    Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction

  2. pocket probing depth (PPD)

    Time frame: 12 months postoperatively

    Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus

  3. Clinical attachment loss (CAL)

    Time frame: 12 months postoperatively

    Clinical attachment loss in millimeters

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: EmdoDerm

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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