Back to resultsTreatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix (EmdoDerm)
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of coronally advanced flap (CAF) and collagen matrix (CM)
Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring coronally advanced flap, collagen, enamel matrix protein, dental enamel protein, gingival recession, periodontal plastic surgery
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CAF + CM
CAF + CM +EMD
Arm Description
Coronally advanced flap (CAF) and collagen matrix (CM)
Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Outcomes
Primary Outcome Measures
Gingival recession height
Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin
Secondary Outcome Measures
Width of keratinized tissue (WKT)
Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction
pocket probing depth (PPD)
Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus
Clinical attachment loss (CAL)
Clinical attachment loss in millimeters
Full Information
NCT ID
NCT05799859
First Posted
March 23, 2023
Last Updated
March 23, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05799859
Brief Title
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
Acronym
EmdoDerm
Official Title
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
coronally advanced flap, collagen, enamel matrix protein, dental enamel protein, gingival recession, periodontal plastic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAF + CM
Arm Type
Active Comparator
Arm Description
Coronally advanced flap (CAF) and collagen matrix (CM)
Arm Title
CAF + CM +EMD
Arm Type
Experimental
Arm Description
Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Intervention Type
Device
Intervention Name(s)
Use of coronally advanced flap (CAF) and collagen matrix (CM)
Intervention Type
Device
Intervention Name(s)
Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
Primary Outcome Measure Information:
Title
Gingival recession height
Description
Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Width of keratinized tissue (WKT)
Description
Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction
Time Frame
12 months postoperatively
Title
pocket probing depth (PPD)
Description
Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus
Time Frame
12 months postoperatively
Title
Clinical attachment loss (CAL)
Description
Clinical attachment loss in millimeters
Time Frame
12 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
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