Periodontal Bone LossPhase 4NCT07183631
Healing of Intrabony Defects Following Treatment With PRF or EMD
A Phase 4 study testing Platelet rich fibrin and Enamel matrix derivate in people with Periodontal Bone Loss and Periodontal Disease, run by Semmelweis University at 1 site in Hungary.
Trial summary
Objective: To evaluate clinically the long-term results following treatment of deep intrabony defects with either platelet-rich fibrin gel (PRF) or an enamel matrix derivative (EMD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Bone Loss, Periodontal Disease, Platelet Rich Fibrin
- What is being tested?
- Platelet rich fibrin and Enamel matrix derivate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2021to 25 Aug 2025
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No systemic conditions affecting treatment outcomes
- Good oral hygiene [plaque index (PI) <1; Löe 1967]
- Compliance with the maintenance program
- Presence of at least one intra-bony defect with a probing depth (PD) of ≥6 mm and an intra-bony component of ≥3 mm confirmed by radiographs.
Who cannot join
- significant medical conditions: irradiation in the maxillofacial area, uncontrolled diabetes or hypertension, systemic steroid or bisphosphonate treatment, pregnancy, or lactation, infectious diseases,
- age <18 years, (3) smokers (>5 cigarettes/day),
- high residual inflammation (FMBS >25%),
- poor oral hygiene (FMPS >25%), and
- defect-related factors: furcation involvement, endo-perio defects, horizontal defects, or multi-tooth defects .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Treatment of Intra-bony Defects With PRF or EMD
Objective: To evaluate clinically the long-term results following treatment of deep intrabony defects with either platelet-rich fibrin gel (PRF) or an enamel matrix derivative (EMD).
Methods: Twenty six patients diagnosed with advanced chronic periodontitis, and each of whom displaying one deep intrabony defect were randomly treated with open flap debridement and with either PRF (test) or EMD (Emdogain, Straumann, Basel, Switzerland) (control). The clinical outcomes were evaluated at baseline, at six months and three years after treatment. The primary outcome variable was the clinical attachment level (CAL).
- Being tested
- Platelet rich fibrin, Enamel matrix derivate
- Medical subject headings
- Alveolar Bone Loss, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinOther
Platelet-rich fibrin (PRF) was prepared according to the manufacturer's instructions. A blood sample was collected from the cubital vein in 10 ml tubes without anticoagulant and centrifuged at 3000 rpm for 10 minutes using a GLO GT416 table centrifuge (GLO Glotech Co. Ltd, Korea) and GLO PRP collection kit (GLO PRP-Kit, Glotech Co, Asan Choong-nam, Korea/ Glofinn, Finland).
Enamel matrix derivateOther
In the control group, the root surface was conditioned with 24% ethylenediaminetetraacetic acid (EDTA) gel for two minutes, washed with physiological saline solution, dried, and treated with enamel matrix derivative (EMD), ("Emdogain", Straumann, Switzerland) per manufacturer recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich fibrin | Experimental | Not described Receives: Other: Platelet rich fibrin |
| Enamel matrix derivate | Sham comparator | Not described Receives: Other: Enamel matrix derivate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Measured: preop and after 6 months
Secondary outcomes (2)
Gingival recession
Measured: preop and after 6 months
Clinical attachment loss
Measured: preop and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Sep 2021
- Primary completion1 Aug 2025
- Study completion25 Aug 2025
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 Bone LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Solyom, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183631
- Sponsor's protocol ID
- PRF_EMD periodontal defect
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dori F, Nemeth F, Arweiler N, Solyom E. Three-year results of a prospective, controlled clinical study evaluating treatment of intra-bony defects with PRF or EMD- a randomized control trial. BMC Oral Health. 2026 Jun 15. doi: 10.1186/s12903-026-08845-y. Online ahead of print.
PubMed 42298534
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Treatment of Intra-bony Defects With PRF or EMD
- ClinicalTrials.gov ID
- NCT07183631
- Acronym / sponsor ID
- PRF_EMD periodontal defect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 19 Sep 2025 (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.
Objective: To evaluate clinically the long-term results following treatment of deep intrabony defects with either platelet-rich fibrin gel (PRF) or an enamel matrix derivative (EMD).
Methods: Twenty six patients diagnosed with advanced chronic periodontitis, and each of whom displaying one deep intrabony defect were randomly treated with open flap debridement and with either PRF (test) or EMD (Emdogain, Straumann, Basel, Switzerland) (control). The clinical outcomes were evaluated at baseline, at six months and three years after treatment. The primary outcome variable was the clinical attachment level (CAL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich fibrin | Experimental | Other: Platelet rich fibrin |
| Enamel matrix derivate | Sham comparator | Other: Enamel matrix derivate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No systemic conditions affecting treatment outcomes
- Good oral hygiene [plaque index (PI) <1; Löe 1967]
- Compliance with the maintenance program
- Presence of at least one intra-bony defect with a probing depth (PD) of ≥6 mm and an intra-bony component of ≥3 mm confirmed by radiographs.
Key exclusion criteria (5 listed)
- significant medical conditions: irradiation in the maxillofacial area, uncontrolled diabetes or hypertension, systemic steroid or bisphosphonate treatment, pregnancy, or lactation, infectious diseases,
- age <18 years, (3) smokers (>5 cigarettes/day),
- high residual inflammation (FMBS >25%),
- poor oral hygiene (FMPS >25%), and
- defect-related factors: furcation involvement, endo-perio defects, horizontal defects, or multi-tooth defects .
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 |
|---|---|---|
| Platelet rich fibrinPlatelet-rich fibrin (PRF) was prepared according to the manufacturer's instructions. A blood sample was collected from the cubital vein in 10 ml tubes without anticoagulant and centrifuged at 3000 rpm for 10 minutes using a GLO GT416 table centrifuge (GLO Glotech Co. Ltd, Korea) and GLO PRP collection kit (GLO PRP-Kit, Glotech Co, Asan Choong-nam, Korea/ Glofinn, Finland). | Other | Platelet-rich fibrin |
| Enamel matrix derivateIn the control group, the root surface was conditioned with 24% ethylenediaminetetraacetic acid (EDTA) gel for two minutes, washed with physiological saline solution, dried, and treated with enamel matrix derivative (EMD), ("Emdogain", Straumann, Switzerland) per manufacturer recommendations. | Other | Enamel matrix derivate |
Primary outcome
Probing pocket depth (PPD)
Time frame: preop and after 6 months
2 secondary outcomes
Gingival recession
Time frame: preop and after 6 months
Clinical attachment loss
Time frame: preop and after 6 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 19 Sep 2025.
- Derived from this study: PubMed 42298534Dori F, Nemeth F, Arweiler N, Solyom E. Three-year results of a prospective, controlled clinical study evaluating treatment of intra-bony defects with PRF or EMD- a randomized control trial. BMC Oral Health. 2026 Jun 15. doi: 10.1186/s12903-026-08845-y. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet rich fibrin and Enamel matrix derivate in people with Periodontal Bone Loss and Periodontal Disease, 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 4 inclusion and 5 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 19 Sep 2025. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Probing pocket depth (PPD) (time frame: preop and after 6 months). 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 NCT07183631, 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 19 Sep 2025.