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OpenTrials
Completed

NCT Number: NCT06179277

Effect of Emdogain® on Soft Tissue Wound Healing

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto, Faculty of Dentistry

Toronto, Ontario, M5G 1G6, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PrefGel® + Emdogain®

Device

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®

Device

Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®)

Primary outcomes

  1. Clinician-reported degree of inflammation

    Time frame: One, two, four and eight-week follow-ups

    Presence and degree of inflammation (appearance of erythema/edema) using VAS score

  2. Clinician-reported quality of healing

    Time frame: One, two, four and eight-week follow-ups

    Overall healing using VAS score

  3. Patient-reported perception of pain

    Time frame: One, two, four and eight-week follow-ups

    Pain score using VAS

  4. Patient-reported swelling

    Time frame: One, two, four and eight-week follow-ups

    Swelling score using VAS

Secondary outcomes

  1. Number of analgesics

    Time frame: One, two, four and eight-week follow-ups

    Number of analgesics taken by each participant post-operatively

Sponsors and collaborators

Lead sponsor

Amir Azarpazhooh

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Dec 21, 2023
Registry last updated
Dec 21, 2023

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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