Periodontal Inflammation Clinical Trial
Official title:
Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
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 |
Verified date | December 2023 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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®.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Toronto, Faculty of Dentistry | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Amir Azarpazhooh | Institut Straumann AG |
Canada,
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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