Effect of Emdogain® on Soft Tissue Wound Healing

NCT06179277 | Completed

• 1 other identifier: 37028
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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®.

Conditions

Periodontal Inflammation; Crown Lengthening

Outcome Measures

Primary Outcomes (4)

• 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

• Clinician-reported quality of healing

  Overall healing using VAS score

  One, two, four and eight-week follow-ups

• Patient-reported perception of pain

  Pain score using VAS

  One, two, four and eight-week follow-ups

• Patient-reported swelling

  Swelling score using VAS

  One, two, four and eight-week follow-ups

Secondary Outcomes (1)

• Number of analgesics

  One, two, four and eight-week follow-ups

Study Arms (2)

Treatment/experimental group

EXPERIMENTAL

Patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain®

Device: PrefGel® + Emdogain®

Control group

PLACEBO COMPARATOR

Patients undergoing surgical crown lengthening of a single site with application of PrefGel® only

Device: PrefGel®

Interventions

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

Treatment/experimental group

PrefGel® DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amir Azarpazhooh: lead
• Institut Straumann AG: collaborator

Study Sites (1)

University of Toronto, Faculty of Dentistry

Toronto, Ontario, M5G 1G6, Canada

Location

Study Officials

• Howard Tenenbaum, Dr

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants remained blinded with respect to their group assignment for the duration of the study. Allocation concealment was done by placing randomization codes with group assignment in opaque sealed envelopes that were opened by the operator at the end of the surgical procedure, right before suturing, which means the surgeon was blinded throughout most of the treatment. Data was collected by a separate examiner who was also blinded to treatment allocation. Data analysis was carried out by an external statistician, minimizing the risk of bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: April 8, 2019
• Primary Completion: November 9, 2020
• Study Completion: October 11, 2021
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)