Effect of Emdogain® on Soft Tissue Wound Healing

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Periodontal Inflammation, Crown Lengthening

Intervention / Treatment
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* Device: PrefGel® + Emdogain®
* Device: PrefGel®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment/experimental group<br>Patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain® | Device: PrefGel® + Emdogain®<br>* 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<br>|
| Placebo Comparator: Control group<br>Patients undergoing surgical crown lengthening of a single site with application of PrefGel® only | Device: PrefGel®<br>* Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-reported degree of inflammation | Presence and degree of inflammation (appearance of erythema/edema) using VAS score | One, two, four and eight-week follow-ups | 
| Clinician-reported quality of healing | Overall healing using VAS score | One, two, four and eight-week follow-ups | 
| Patient-reported perception of pain | Pain score using VAS | One, two, four and eight-week follow-ups | 
| Patient-reported swelling | Swelling score using VAS | One, two, four and eight-week follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesics | Number of analgesics taken by each participant post-operatively | One, two, four and eight-week follow-ups |