Periodontal InflammationNCT06179277
Effect of Emdogain® on Soft Tissue Wound Healing
A study testing PrefGel® + Emdogain® and PrefGel® in people with Periodontal Inflammation and Crown Lengthening, run by Amir Azarpazhooh at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation, Crown Lengthening
- What is being tested?
- PrefGel® + Emdogain® and PrefGel®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2019to 11 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Faculty of Dentistry
Toronto, Ontario, M5G 1G6
About this study
Official title: Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
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®.
Read the 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:
- 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
- Conditions
- Periodontal Inflammation, Crown Lengthening
- Being tested
- PrefGel® + Emdogain®, PrefGel®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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®)
| Study group | Role | What they receive |
|---|---|---|
| Treatment/experimental group | Experimental | Patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain® Receives: Device: PrefGel® + Emdogain® |
| Control group | Placebo comparator | Patients undergoing surgical crown lengthening of a single site with application of PrefGel® only Receives: Device: PrefGel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-reported degree of inflammation
Presence and degree of inflammation (appearance of erythema/edema) using VAS score
Measured: One, two, four and eight-week follow-ups
Clinician-reported quality of healing
Overall healing using VAS score
Measured: One, two, four and eight-week follow-ups
Patient-reported perception of pain
Pain score using VAS
Measured: One, two, four and eight-week follow-ups
Patient-reported swelling
Swelling score using VAS
Measured: One, two, four and eight-week follow-ups
Secondary outcomes (1)
Number of analgesics
Number of analgesics taken by each participant post-operatively
Measured: One, two, four and eight-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start8 Apr 2019
- Primary completion9 Nov 2020
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amir Azarpazhooh
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor-investigator, Amir Azarpazhooh, University of Toronto
- Investigators
- Howard Tenenbaum, Dr, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179277
- Sponsor's protocol ID
- 37028
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enamel Matrix Derivative (Emdogain®) on Soft Tissue Wound Healing Following Surgical Crown Lengthening Procedures
- ClinicalTrials.gov ID
- NCT06179277
- Acronym / sponsor ID
- 37028
- Conditions
- Periodontal Inflammation, Crown Lengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amir AzarpazhoohUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment/experimental group | Experimental | Device: PrefGel® + Emdogain®Patients undergoing surgical crown lengthening of a single site with application of PrefGel® + Emdogain® |
| Control group | Placebo comparator | Device: PrefGel®Patients undergoing surgical crown lengthening of a single site with application of PrefGel® only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrefGel® + Emdogain®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 | Device | Treatment/experimental group |
| PrefGel®Surgical crown lengthening procedure with root conditioning with 24% EDTA (PrefGel®) | Device | Control group |
Primary outcome
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
Clinician-reported quality of healing
Time frame: One, two, four and eight-week follow-ups
Overall healing using VAS score
Patient-reported perception of pain
Time frame: One, two, four and eight-week follow-ups
Pain score using VAS
Patient-reported swelling
Time frame: One, two, four and eight-week follow-ups
Swelling score using VAS
1 secondary outcome
Number of analgesics
Time frame: One, two, four and eight-week follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Tenenbaum, Dr principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrefGel® + Emdogain® and PrefGel® in people with Periodontal Inflammation and Crown Lengthening, run by Amir Azarpazhooh at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-reported degree of inflammation (time frame: One, two, four and eight-week follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.