PeriodontitisNCT04449393
Enamel Matrix Derivative in Non-surgical Periodontal Treatment
A study testing Emdogain® FL and Scaling and root planing in people with Periodontitis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Emdogain® FL and Scaling and root planing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- 15 Sep 2020to 1 Jul 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis stage III
- Patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm PPD
- Given written informed consent form for participation in the study
Who cannot join
- Systemic antibiotics within the previous 3 months
- Pregnant or breastfeeding women
- Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome.
- Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or I according to Hamp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
The aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.
Read the detailed description
Enamel matrix derivative (EMD) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. Recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis.
The present study is designed as a single-blinded randomized controlled clinical trial. We plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.
- Conditions
- Periodontitis
- Being tested
- Emdogain® FL, Scaling and root planing
- Keywords
- Enamel Matrix Derivative, Periodontitis, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emdogain® FLDevice
Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.
Scaling and root planingOther
Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.
| Study group | Role | What they receive |
|---|---|---|
| Emdogain® FL | Experimental | Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation. EDTA gel will be applied for 2 minutes in the respective pockets, followed by rinsing with saline, drying and application of Emdogain® FL. Receives: Device: Emdogain® FL |
| Control group | Placebo comparator | Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation, followed by rinsing with saline. Receives: Other: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal probing depth (PPD)
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Measured: At baseline
Periodontal probing depth (PPD)
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Measured: After 3 months
Periodontal probing depth (PPD)
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Measured: After 6 months
Periodontal probing depth (PPD)
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Measured: After 12 months
Secondary outcomes (5)
CAL (mm)
CAL (Clinical attachment level): the probing depth and the distance from the gingival margin to the CEJ API: Approximal plaque index PBI: Papillary Bleeding Index PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area GCF: Gingival crevicular fluid
Measured: At baseline, after 3, 6 and 12 months
API, PBI (%)
API: Approximal plaque index PBI: Papillary Bleeding Index
Measured: At baseline, after 3, 6 and 12 months
PESA, PISA (mm2)
PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area
Measured: At baseline, after 3, 6 and 12 months
GCF markers for periodontal regeneration
GCF: Gingival crevicular fluid
Measured: At baseline, after 3, 6 and 12 months
Periodontal bacteria
Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit
Measured: At baseline, after 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start15 Sep 2020
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Wehner, DMD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449393
- Sponsor's protocol ID
- 1248/2020
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wehner C, Tur D, Durstberger G, Laky M, Laky B, Andrukhov O, Moritz A, Rausch-Fan X. Effects of enamel matrix derivative in nonsurgical periodontal therapy on pro-inflammatory profiles, microbial environment and clinical outcome: a randomized clinical trial. Clin Oral Investig. 2023 Nov;27(11):6493-6502. doi: 10.1007/s00784-023-05254-1. Epub 2023 Oct 16.
PubMed 37843637
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
- ClinicalTrials.gov ID
- NCT04449393
- Acronym / sponsor ID
- 1248/2020
- Conditions
- Periodontitis
- Keywords
- Enamel Matrix Derivative, Periodontitis, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 26 Jun 2020 (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 aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.
Detailed description
Enamel matrix derivative (EMD) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. Recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis.
The present study is designed as a single-blinded randomized controlled clinical trial. We plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emdogain® FL | Experimental | Device: Emdogain® FLNon-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation. EDTA gel will be applied for 2 minutes in the respective pockets, followed by rinsing with saline, drying and application of Emdogain® FL. |
| Control group | Placebo comparator | Other: Scaling and root planingNon-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation, followed by rinsing with saline. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Periodontitis stage III
- Patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm PPD
- Given written informed consent form for participation in the study
Key exclusion criteria (4 listed)
- Systemic antibiotics within the previous 3 months
- Pregnant or breastfeeding women
- Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome.
- Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or I according to Hamp
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 |
|---|---|---|
| Emdogain® FLEmdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets. | Device | Emdogain® FL |
| Scaling and root planingScaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers. | Other | Control group |
Primary outcome
Periodontal probing depth (PPD)
Time frame: At baseline
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Periodontal probing depth (PPD)
Time frame: After 3 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Periodontal probing depth (PPD)
Time frame: After 6 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Periodontal probing depth (PPD)
Time frame: After 12 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
5 secondary outcomes
CAL (mm)
Time frame: At baseline, after 3, 6 and 12 months
API, PBI (%)
Time frame: At baseline, after 3, 6 and 12 months
PESA, PISA (mm2)
Time frame: At baseline, after 3, 6 and 12 months
GCF markers for periodontal regeneration
Time frame: At baseline, after 3, 6 and 12 months
Periodontal bacteria
Time frame: At baseline, after 3, 6 and 12 months
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 25 Oct 2022.
- Derived from this study: PubMed 37843637Wehner C, Tur D, Durstberger G, Laky M, Laky B, Andrukhov O, Moritz A, Rausch-Fan X. Effects of enamel matrix derivative in nonsurgical periodontal therapy on pro-inflammatory profiles, microbial environment and clinical outcome: a randomized clinical trial. Clin Oral Investig. 2023 Nov;27(11):6493-6502. doi: 10.1007/s00784-023-05254-1. Epub 2023 Oct 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emdogain® FL and Scaling and root planing in people with Periodontitis, run by Medical University of Vienna at 1 site in Austria.
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 4 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 25 Oct 2022. 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 Austria. 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?
Periodontal probing depth (PPD) (time frame: At baseline). 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?
On the ClinicalTrials.gov record for NCT04449393, which also lists 1 linked publication.
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 25 Oct 2022.