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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06179277
Other study ID # 37028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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