Clinical trial NCT06179277: Effect of Emdogain® on Soft Tissue Wound Healing
Official title: Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Inflammation
Crown Lengthening
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2023-12-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinician-reported degree of inflammation
timeFrame: One, two, four and eight-week follow-ups
measure: Clinician-reported quality of healing
timeFrame: One, two, four and eight-week follow-ups
measure: Patient-reported perception of pain
timeFrame: One, two, four and eight-week follow-ups
measure: Patient-reported swelling
timeFrame: One, two, four and eight-week follow-ups
Secondary outcomes:
measure: Number of analgesics
timeFrame: One, two, four and eight-week follow-ups
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Faculty of Dentistry
state: Ontario
Study officials:
affiliation: University of Toronto
name: Howard Tenenbaum, Dr
role: PRINCIPAL_INVESTIGATOR
References: