Periodontal DiseasesNCT04404374
Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
A study testing A-PRF/EMD in people with Periodontal Diseases, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- A-PRF/EMD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 27 Jun 2018to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees, with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs, no smoking
Who cannot join
- systemic diseases that could influence the outcome of the therapy, poor oral hygiene, smoking, horizontal bone loss
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Periodontology
Budapest, 1088
About this study
Official title: Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
The aim of this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients.
Read the detailed description
Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability.
- Conditions
- Periodontal Diseases
- Being tested
- A-PRF/EMD
- Keywords
- Intrabony Defects, New-Generation Platelet-Rich Fibrin, Enamel Matrix Derivatives, Periodontal Regeneration, EMD, A-PRF+, Advanced Platelet-Rich Fibrin
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRF/EMDProcedure or surgery
Comparing healing effect of an autologous and a xenogenic product
| Study group | Role | What they receive |
|---|---|---|
| A-PRF | Active comparator | Advanced Platelet-Rich Fibrin Receives: Procedure: A-PRF/EMD |
| EMD | Active comparator | Enamel Matrix Derivatives Receives: Procedure: A-PRF/EMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal clinical parameters - to determine the clinical attachment level (CAL)
With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
Measured: Change from baseline after 6 month and after 12 month
Periodontal clinical parameters
With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
Measured: Change from baseline after 6 month and after 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 Jun 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
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 Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boroka Csifo-Nagy, Semmelweis University
- Investigators
- Ferenc Dr.Dőri, professor, Study director, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404374
- Sponsor's protocol ID
- SE TUKEB: 254/2017
- Status last verified
- Mar 2021
- First submitted
- 19 May 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Csifo-Nagy BK, Solyom E, Bognar VL, Nevelits A, Dori F. Efficacy of a new-generation platelet-rich fibrin in the treatment of periodontal intrabony defects: a randomized clinical trial. BMC Oral Health. 2021 Nov 15;21(1):580. doi: 10.1186/s12903-021-01925-1.
PubMed 34781955
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04404374
- Acronym / sponsor ID
- SE TUKEB: 254/2017
- Conditions
- Periodontal Diseases
- Keywords
- Intrabony Defects, New-Generation Platelet-Rich Fibrin, Enamel Matrix Derivatives, Periodontal Regeneration, EMD, A-PRF+, Advanced Platelet-Rich Fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 May 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 this randomized clinical trial was to clinically evaluate and compare the healing of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel matrix derivatives (EMD) in periodontitis patients.
Detailed description
Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed with sutures to ensure wound closure and stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-PRF | Active comparator | Procedure: A-PRF/EMDAdvanced Platelet-Rich Fibrin |
| EMD | Active comparator | Procedure: A-PRF/EMDEnamel Matrix Derivatives |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no systemic diseases that could influence the outcome of the therapy, a good level of oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a defect angle of 20-40 (+/- 5) degrees, with a minimum PPD of 6 mm and intrabony component of a minimum 4 mm as detected on radiographs, no smoking
Key exclusion criteria (1 listed)
- systemic diseases that could influence the outcome of the therapy, poor oral hygiene, smoking, horizontal bone loss
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 |
|---|---|---|
| A-PRF/EMDComparing healing effect of an autologous and a xenogenic product | Procedure or surgery | A-PRF, EMD |
Primary outcome
Periodontal clinical parameters - to determine the clinical attachment level (CAL)
Time frame: Change from baseline after 6 month and after 12 month
With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
Periodontal clinical parameters
Time frame: Change from baseline after 6 month and after 12 month
With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
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 Mar 2021.
- Derived from this study: PubMed 34781955Csifo-Nagy BK, Solyom E, Bognar VL, Nevelits A, Dori F. Efficacy of a new-generation platelet-rich fibrin in the treatment of periodontal intrabony defects: a randomized clinical trial. BMC Oral Health. 2021 Nov 15;21(1):580. doi: 10.1186/s12903-021-01925-1.
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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.
Ferenc Dr.Dőri, professor study director
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-PRF/EMD in people with Periodontal Diseases, run by Semmelweis University at 1 site in Hungary.
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 1 inclusion and 1 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 Mar 2021. 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 Hungary. 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. 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 clinical parameters - to determine the clinical attachment level (CAL) (time frame: Change from baseline after 6 month and after 12 month). The study lists 2 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 NCT04404374, 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 5 Mar 2021.