Gingival RecessionEmdoDermNCT05799859
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix
A study testing Use of coronally advanced flap (CAF) and collagen matrix (CM) and Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). in people with Gingival Recession, run by Medical University of Graz.
Trial summary
The clinical trial studies patients with gingival recession defects (receding gums). The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Use of coronally advanced flap (CAF) and collagen matrix (CM) and Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 22 Sep 2022
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- able to achieve good oral hygiene (full mouth plaque score < 20 %, full mouth bleeding score < 20%),
- patients presenting with at least one gingival recession defect
Who cannot join
- general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);
- ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;
- self-reported heavy smokers (more than 10 cigarettes/day);
- pregnancy and nursing mothers;
- disorders or treatments that impair wound healing;
- long-term treatment with high-dose steroids or anticoagulants;
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- bone metabolism disorders;
- infections or vascular disorders in the region to be treated;
- known hypersensitivity to porcine collagen;
- patients with severe peripheral artery disease or autoimmune diseases;
- extruded or malpositioned teeth.
About this study
Official title: Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial
The clinical trial studies patients with gingival recession defects (receding gums).
The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.
Read the detailed description
The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.
In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.
15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.
- Conditions
- Gingival Recession
- Being tested
- Use of coronally advanced flap (CAF) and collagen matrix (CM), Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).
- Keywords
- coronally advanced flap, collagen, enamel matrix protein, dental enamel protein, gingival recession, periodontal plastic surgery
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of coronally advanced flap (CAF) and collagen matrix (CM)Device
Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).Device
| Study group | Role | What they receive |
|---|---|---|
| CAF + CM | Active comparator | Coronally advanced flap (CAF) and collagen matrix (CM) Receives: Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) |
| CAF + CM +EMD | Experimental | Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). Receives: Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival recession height
Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin
Measured: 12 months postoperatively
Secondary outcomes (3)
Width of keratinized tissue (WKT)
Width of keratinized tissue in millimeters, .as distance between gingival margin and muco-gingival junction
Measured: 12 months postoperatively
pocket probing depth (PPD)
Pocket probing depth in millimeters, measured as the distance from gingival margin to bottom of gingival sulcus
Measured: 12 months postoperatively
Clinical attachment loss (CAL)
Clinical attachment loss in millimeters
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start9 Jan 2017
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799859
- Sponsor's protocol ID
- EmdoDerm
- Acronym
- EmdoDerm
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 5 Apr 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05799859
- Acronym / sponsor ID
- EmdoDerm / EmdoDerm
- Conditions
- Gingival Recession
- Keywords
- coronally advanced flap, collagen, enamel matrix protein, dental enamel protein, gingival recession, periodontal plastic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 5 Apr 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 clinical trial studies patients with gingival recession defects (receding gums).
The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.
Detailed description
The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.
In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.
15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF + CM | Active comparator | Device: Use of coronally advanced flap (CAF) and collagen matrix (CM)Coronally advanced flap (CAF) and collagen matrix (CM) |
| CAF + CM +EMD | Experimental | Device: Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD).Coronally advanced flap (CAF), collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- able to achieve good oral hygiene (full mouth plaque score < 20 %, full mouth bleeding score < 20%),
- patients presenting with at least one gingival recession defect
Key exclusion criteria (11 listed)
- general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);
- ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;
- self-reported heavy smokers (more than 10 cigarettes/day);
- pregnancy and nursing mothers;
- disorders or treatments that impair wound healing;
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 |
|---|---|---|
| Use of coronally advanced flap (CAF) and collagen matrix (CM) | Device | CAF + CM |
| Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). | Device | CAF + CM +EMD |
Primary outcome
Gingival recession height
Time frame: 12 months postoperatively
Gingival recession height in millimeters, measured as the distance from cementoenamel junction to gingival margin
3 secondary outcomes
Width of keratinized tissue (WKT)
Time frame: 12 months postoperatively
pocket probing depth (PPD)
Time frame: 12 months postoperatively
Clinical attachment loss (CAL)
Time frame: 12 months postoperatively
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 5 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of coronally advanced flap (CAF) and collagen matrix (CM) and Use of coronally advanced flap (CAF) and collagen matrix (CM) and additional application of enamel matrix derivatives (EMD). in people with Gingival Recession, run by Medical University of Graz.
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 3 inclusion and 11 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Gingival recession height (time frame: 12 months postoperatively). 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 5 Apr 2023.