Periodontal DiseasesNCT04823572
Treatment of Periodontal Intrabony Defects With A-PRF or OFD
A study testing A-PRF/OFD 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+) toped flap debridement (OFD) in periodontitis patients. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- A-PRF/OFD
- 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
- 1 Feb 2020to 28 Feb 2024
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no systemic diseases
- a good level of oral hygiene
- 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 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+) toped flap debridement (OFD) in periodontitis patients.
Read the detailed description
Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement in the control group, and fixed with sutures to ensure wound closure and stability.
- Conditions
- Periodontal Diseases
- Being tested
- A-PRF/OFD
- Keywords
- Intrabony Defects, Periodontal Regeneration, A-PRF, Advanced Platelet-Rich Fibrin, Open Flap Debridement
- 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/OFDProcedure or surgery
Comparing healing effect of an autologous and open flap debridement
| Study group | Role | What they receive |
|---|---|---|
| A-PRF Advanced Platelet-Rich Fibrin | Active comparator | Comparing healing effect of an autologous product with open flap debridement. Receives: Procedure: A-PRF/OFD |
| OFD Open Flap Debridement | Active comparator | Comparing healing effect of an autologous product with open flap debridement. Receives: Procedure: A-PRF/OFD |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Feb 2020
- Primary completion30 Sep 2022
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sponsor
- Investigators
- Dőri Ferenc, Professor, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823572
- Sponsor's protocol ID
- SE TUKEB 254/2017
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New-generation Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04823572
- Acronym / sponsor ID
- SE TUKEB 254/2017
- Conditions
- Periodontal Diseases
- Keywords
- Intrabony Defects, Periodontal Regeneration, A-PRF, Advanced Platelet-Rich Fibrin, Open Flap Debridement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 1 Apr 2021 (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+) toped flap debridement (OFD) in periodontitis patients.
Detailed description
Thirty (30) intrabony defects are randomly divided in two treatment groups: test (n = 15) and control (n = 15). The intrabony defects are filled with A-PRF+ (n=15) in the test group, respectively treated with open flap debridement 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 Advanced Platelet-Rich Fibrin | Active comparator | Procedure: A-PRF/OFDComparing healing effect of an autologous product with open flap debridement. |
| OFD Open Flap Debridement | Active comparator | Procedure: A-PRF/OFDComparing healing effect of an autologous product with open flap debridement. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- no systemic diseases
- a good level of oral hygiene
- 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 (4 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/OFDComparing healing effect of an autologous and open flap debridement | Procedure or surgery | A-PRF Advanced Platelet-Rich Fibrin, OFD Open Flap Debridement |
Primary outcome
Periodontal clinical parameters
Time frame: Change from baseline after 6 month and after 12 month
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).
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 24 Apr 2024.
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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.
Dőri Ferenc, Professor principal investigator
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/OFD 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 5 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 24 Apr 2024. 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 (time frame: Change from baseline after 6 month and after 12 month). 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 24 Apr 2024.