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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* 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).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAF + CM<br>Coronally advanced flap (CAF) and collagen matrix (CM) | Device: Use of coronally advanced flap (CAF) and collagen matrix (CM)<br> <br> |
| Experimental: CAF + CM +EMD<br>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).<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronally advanced flap, collagen, enamel matrix protein, dental enamel protein, gingival recession, periodontal plastic surgery