Viewing Study NCT06179277



Ignite Creation Date: 2024-05-06 @ 7:54 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06179277
Status: COMPLETED
Last Update Posted: 2023-12-21
First Post: 2023-12-11

Brief Title: Effect of Emdogain on Soft Tissue Wound Healing
Sponsor: Amir Azarpazhooh
Organization: University of Toronto

Study Overview

Official Title: Effect of Enamel Matrix Derivative Emdogain on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
Status: COMPLETED
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Treatmentexperimental 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None