NCT06179277

Effect of Emdogain® on Soft Tissue Wound Healing

Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Amir Azarpazhooh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized, controlled, single-center study is to compare the effects of Emdogain®, a regenerative biomaterial, on post-operative pain, wound healing and inflammation of treated sites after surgical crown lengthening. The main question it aims to answer is: Does the use of Emdogain® in conjunction with crown lengthening surgery improve post-operative soft-tissue healing, decrease inflammation and reduce patient perception of pain compared to crown lengthening without addition of Emdogain®? The treatment group will receive Emdogain® during surgery, and the control group will undergo standard crown lengthening without Emdogain®.

Detailed description

This randomized, controlled, single-center study intends to investigate the effects of Emdogain® on wound healing, postoperative pain and inflammation of treated sites after crown lengthening procedures on a single site, and to compare the results of this therapy with those of standard crown lengthening treatment on a single site. We have hypothesized that the use of Emdogain® in conjunction with crown lengthening surgery improves post-operative soft-tissue healing, decreases inflammation and reduces patient perception of pain compared to crown lengthening without addition of Emdogain®. Patients were recruited from the Graduate Periodontology clinic at the Faculty of Dentistry, University of Toronto. These patients were referred to the department by dental students in the faculty as well as dentists and dental specialists within the community for crown lengthening surgery, and were subsequently screened for eligibility to participate in the study. After confirmation of eligibility and completion of recruitment, patients were randomized, using a computer-generated randomization table, into the following groups: * Treatment/experimental group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain® * Control group: patients undergoing surgical crown lengthening of a single site with application of PrefGel® only

Conditions

• Periodontal Inflammation
• Crown Lengthening

Interventions

Type	Name	Description
DEVICE	PrefGel® + Emdogain®	Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®) and application of 0.3 mL Emdogain® to root surface with 27-gauge needle
DEVICE	PrefGel®	Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®)

Timeline

• Start date: 2019-04-08
• Primary completion: 2020-11-09
• Completion: 2021-10-11
• First posted: 2023-12-21
• Last updated: 2023-12-21

Locations

1 site across 1 country: Canada