Clinical trial NCT05799859: Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
Official title: Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: coronally advanced flap
collagen
enamel matrix protein
dental enamel protein
gingival recession
periodontal plastic surgery
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gingival recession height
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Width of keratinized tissue (WKT)
timeFrame: 12 months postoperatively
measure: pocket probing depth (PPD)
timeFrame: 12 months postoperatively
measure: Clinical attachment loss (CAL)
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References: