Effect of Emdogain® on Soft Tissue Wound Healing

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

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®.

Study Overview

• Status: Completed
• Conditions: Periodontal Inflammation; Crown Lengthening
• Intervention / Treatment: Device: PrefGel® + Emdogain®; Device: PrefGel®

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1G6
      • University of Toronto, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amir Azarpazhooh
• Collaborators: Institut Straumann AG
• Investigators: Principal Investigator: Howard Tenenbaum, Dr, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): November 9, 2020
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 37028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No