Effect of Emdogain® on Soft Tissue Wound Healing

Periodontal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179277
• Other study ID #: 37028
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: October 11, 2021

Study information

• Verified date: December 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 11, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crown Lengthening
• Inflammation
• Periodontal Inflammation

Intervention

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
• PrefGel®
Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®)

Locations

Country	Name	City	State
Canada	University of Toronto, Faculty of Dentistry	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Amir Azarpazhooh	Institut Straumann AG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinician-reported quality of healing	Overall healing using VAS score	One, two, four and eight-week follow-ups
Primary	Patient-reported perception of pain	Pain score using VAS	One, two, four and eight-week follow-ups
Primary	Patient-reported swelling	Swelling score using VAS	One, two, four and eight-week follow-ups
Secondary	Number of analgesics	Number of analgesics taken by each participant post-operatively	One, two, four and eight-week follow-ups