Effect of Emdogain® on Soft Tissue Wound Healing

Amir Azarpazhooh

Status

Completed

Conditions

Crown Lengthening

Periodontal Inflammation

Treatments

Device: PrefGel®

Device: PrefGel® + Emdogain®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06179277

37028

Details and patient eligibility

About

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®.

Full 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

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients who:

Were capable and willing to provide consent and complete treatment as well as follow-up appointments
Were over the age of 18 years old
Required surgical crown lengthening for functional reasons as outlined in background
Had no contraindications to surgery (these include periodontal contraindications to crown lengthening such as poor crown-to-root ratio, furcation exposure or esthetic concerns)

Exclusion criteria

Patients who were unable to provide informed consent
Pregnant women
Women receiving estrogen therapy
Patients who had received systemic antibiotics within the past 6 months
Patients with severe systemic disease (ASA 3+) including: poorly controlled diabetes, blood dyscrasias, liver disease, immunosuppressive disorders, malignancy or who have had previous radiotherapy
Patients with untreated, active periodontal disease