Effect of Emdogain® on Soft Tissue Wound Healing

Not Applicable

Completed

• Conditions: Periodontal Inflammation; Crown Lengthening
• Interventions: Device: PrefGel®; Device: PrefGel® + Emdogain®

• Registration Number: NCT06179277
• Lead Sponsor: Amir Azarpazhooh

Brief 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

Study Timeline

• Study Start: 2019-04-08
• Primary Completion: 2020-11-09
• Study Completion: 2021-10-11
• Status Verified: 2023-12
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	PrefGel®	Patients undergoing surgical crown lengthening of a single site with application of PrefGel® only
Treatment/experimental group	PrefGel® + Emdogain®	Patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain®

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of analgesics	One, two, four and eight-week follow-ups	Number of analgesics taken by each participant post-operatively

Trial Locations

Locations (1)

University of Toronto, Faculty of Dentistry; 🇨🇦 Toronto, Ontario, Canada