University of Toronto, Faculty of Dentistry
Toronto, Ontario, M5G 1G6, Canada
NCT Number: NCT06179277
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®.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 1G6, Canada
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients who:
Exclusion criteria
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
Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®)
Time frame: One, two, four and eight-week follow-ups
Presence and degree of inflammation (appearance of erythema/edema) using VAS score
Time frame: One, two, four and eight-week follow-ups
Overall healing using VAS score
Time frame: One, two, four and eight-week follow-ups
Pain score using VAS
Time frame: One, two, four and eight-week follow-ups
Swelling score using VAS
Time frame: One, two, four and eight-week follow-ups
Number of analgesics taken by each participant post-operatively
Amir Azarpazhooh
Other
Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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