Peridontal DiseaseNCT07841301
PRF Versus Emdogain for Class II Furcation Defects of Mandibular Molars
A study testing Platelet rich fibrin and Emdogain in people with Peridontal Disease and Furcation Defects, run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
This study evaluated the regenerative potential of platelet-rich fibrin (PRF) compared with enamel matrix derivative (Emdogain®) in the surgical treatment of Class II (F2) furcation defects of mandibular molars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peridontal Disease, Furcation Defects
- What is being tested?
- Platelet rich fibrin and Emdogain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBulgaria
- Study dates
- 2 Dec 2021to 29 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals
- Stage III or Stage IV periodontitis
- without allergies.
Who cannot join
- Smoking
- Inadequate plaque control
- Systemic diseases that may compromise periodontal therapy, including diabetes, immunodeficiency, or viral diseases.
- Immunosuppressive therapy.
- Treatment with bisphosphonates.
- Treatment with anticoagulants.
Show all 13Show fewer
- Treatment with antiplatelet agents.
- Thrombocytopenia.
- Hypofibrinogenemia.
- Hemophilia.
- Other coagulation disorders.
- Pregnancy.
- Breastfeeding.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Department of Periodontology, Faculty of Dental Medicine, Medical University of Sofia
Sofia
About this study
Official title: Comparative Evaluation of the Regenerative Potential of Platelet- Rich Fibrin (PRF) and Emdogain® in the Surgical Treatment of Class II Furcation Defects of Mandibular Molars
This study evaluated the regenerative potential of platelet-rich fibrin (PRF) compared with enamel matrix derivative (Emdogain®) in the surgical treatment of Class II (F2) furcation defects of mandibular molars. Twenty-one systemically healthy patients with a total of 30 mandibular molars presenting with buccal Class II furcation defects were included. The furcation defects were treated surgically with either PRF or Emdogain®. Clinical parameters, including periodontal probing depth, clinical attachment level, bleeding on probing, and furcation involvement, were assessed before treatment and during follow-up. Clinical and radiographic measurements of the furcation defects were also performed. The main follow-up evaluation was conducted 6 months after surgery. The study compared the clinical and radiographic outcomes of PRF and Emdogain® in the treatment of mandibular molars with Class II furcation defects.
- Conditions
- Peridontal Disease, Furcation Defects
- Being tested
- Platelet rich fibrin, Emdogain
- Keywords
- Periodontitis, Class II furcation defects, Platelet-rich fibrin, Emdogain, Periodontal regeneration, Mandibular molars
- Medical subject headings
- Furcation Defects, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrinBiological
Also called PRF
Surgical treatment of a buccal Class II furcation defect was performed under local anesthesia. Following flap elevation, complete instrumentation of the root surfaces and furcation defect was performed using hand and powered instruments (scaling and root planing). Horizontal and vertical furcation involvement were measured.
For PRF preparation, peripheral venous blood was collected into two vacuum tubes using a closed butterfly system. The tubes were centrifuged using a PRF DUO centrifuge. PRF from one tube was used to fill the furcation defect, while PRF from the second tube was compressed to form a membrane covering the furcation entrance.
The flap was coronally positioned and secured with sling and interrupted interdental sutures using resorbable 6-0 sutures.
EmdogainBiological
Also called enamel matrix proteins
Surgical treatment of a buccal Class II furcation defect was performed under local anesthesia. Following flap elevation, complete instrumentation of the root surfaces and furcation defect was performed using hand and powered instruments (scaling and root planing). Horizontal and vertical furcation involvement were measured.
The exposed root surfaces were conditioned with 24% EDTA gel (PrefGel®, Straumann; pH 6.7) for 2 minutes, followed by thorough irrigation with sterile saline. Enamel matrix derivative (Emdogain®) was then immediately applied, starting from the most distant part of the furcation defect and covering the entire exposed root surface.
The flap was coronally positioned and secured with sling and interrupted interdental sutures using resorbable 6-0 sutures.
| Study group | Role | What they receive |
|---|---|---|
| PRF | Experimental | Surgical treatment of a mandibular molar with a Class II (F2) furcation defect using platelet-rich fibrin (PRF) following surgical debridement and root surface instrumentation. Receives: Biological: Platelet rich fibrin |
| Emdogain | Active comparator | Surgical treatment of a mandibular molar with a Class II (F2) furcation defect using enamel matrix derivative (Emdogain®) following surgical debridement and conditioning of the root surface with PrefGel®. Receives: Biological: Emdogain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Horizontal Furcation Probing Depth
Change in the horizontal probing depth of the furcation defect, measured at the furcation entrance before surgery and 6 months after surgery. The measurement was used to assess the horizontal component of furcation involvement and the clinical response to treatment.
Measured: Baseline to 6 months after surgery
Secondary outcomes (4)
Change in Probing Pocket Depth
Change in periodontal probing depth at the treated furcation site, measured from m.gingivalis to the bottom of the pocket.
Measured: Baseline to 6 months after surgery
Change in Clinical Attachment Level
Change in clinical attachment level at the treated furcation site, measured from cementoenamel junction to the bottom of the pocket.
Measured: Baseline to 6 months after surgery
Change in Vertical Bone Loss
Change in vertical bone loss associated with the furcation defect, measured on three-dimensional imaging.
Measured: Baseline to 6 months after surgery
Change in Horizontal Bone Loss.
Change in horizontal bone loss associated with the furcation defect, measured on three-dimensional imaging.
Measured: Baseline to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start2 Dec 2021
- Primary completion29 May 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peridontal DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841301
- Sponsor's protocol ID
- D-93/04.06.2021
- Other IDs
- 7888/19. 11. 20
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Regenerative Potential of Platelet- Rich Fibrin (PRF) and Emdogain® in the Surgical Treatment of Class II Furcation Defects of Mandibular Molars
- ClinicalTrials.gov ID
- NCT07841301
- Acronym / sponsor ID
- D-93/04.06.2021
- Conditions
- Peridontal Disease, Furcation Defects
- Keywords
- Periodontitis, Class II furcation defects, Platelet-rich fibrin, Emdogain, Periodontal regeneration, Mandibular molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 25 Sep 2026 (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.
This study evaluated the regenerative potential of platelet-rich fibrin (PRF) compared with enamel matrix derivative (Emdogain®) in the surgical treatment of Class II (F2) furcation defects of mandibular molars. Twenty-one systemically healthy patients with a total of 30 mandibular molars presenting with buccal Class II furcation defects were included. The furcation defects were treated surgically with either PRF or Emdogain®. Clinical parameters, including periodontal probing depth, clinical attachment level, bleeding on probing, and furcation involvement, were assessed before treatment and during follow-up. Clinical and radiographic measurements of the furcation defects were also performed. The main follow-up evaluation was conducted 6 months after surgery. The study compared the clinical and radiographic outcomes of PRF and Emdogain® in the treatment of mandibular molars with Class II furcation defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF | Experimental | Biological: Platelet rich fibrinSurgical treatment of a mandibular molar with a Class II (F2) furcation defect using platelet-rich fibrin (PRF) following surgical debridement and root surface instrumentation. |
| Emdogain | Active comparator | Biological: EmdogainSurgical treatment of a mandibular molar with a Class II (F2) furcation defect using enamel matrix derivative (Emdogain®) following surgical debridement and conditioning of the root surface with PrefGel®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systemically healthy individuals
- Stage III or Stage IV periodontitis
- without allergies.
Key exclusion criteria (13 listed)
- Smoking
- Inadequate plaque control
- Systemic diseases that may compromise periodontal therapy, including diabetes, immunodeficiency, or viral diseases.
- Immunosuppressive therapy.
- Treatment with bisphosphonates.
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 fibrinAlso: PRFSurgical treatment of a buccal Class II furcation defect was performed under local anesthesia. Following flap elevation, complete instrumentation of the root surfaces and furcation defect was performed using hand and powered instruments (scaling and root planing). Horizontal and vertical furcation involvement were measured. For PRF preparation, peripheral venous blood was collected into two vacuum tubes using a closed butterfly system. The tubes were centrifuged using a PRF DUO centrifuge. PRF from one tube was used to fill the furcation defect, while PRF from the second tube was compressed to form a membrane covering the furcation entrance. The flap was coronally positioned and secured with sling and interrupted interdental sutures using resorbable 6-0 sutures. | Biological | PRF |
| EmdogainAlso: enamel matrix proteinsSurgical treatment of a buccal Class II furcation defect was performed under local anesthesia. Following flap elevation, complete instrumentation of the root surfaces and furcation defect was performed using hand and powered instruments (scaling and root planing). Horizontal and vertical furcation involvement were measured. The exposed root surfaces were conditioned with 24% EDTA gel (PrefGel®, Straumann; pH 6.7) for 2 minutes, followed by thorough irrigation with sterile saline. Enamel matrix derivative (Emdogain®) was then immediately applied, starting from the most distant part of the furcation defect and covering the entire exposed root surface. The flap was coronally positioned and secured with sling and interrupted interdental sutures using resorbable 6-0 sutures. | Biological | Emdogain |
Primary outcome
Change in Horizontal Furcation Probing Depth
Time frame: Baseline to 6 months after surgery
Change in the horizontal probing depth of the furcation defect, measured at the furcation entrance before surgery and 6 months after surgery. The measurement was used to assess the horizontal component of furcation involvement and the clinical response to treatment.
4 secondary outcomes
Change in Probing Pocket Depth
Time frame: Baseline to 6 months after surgery
Change in Clinical Attachment Level
Time frame: Baseline to 6 months after surgery
Change in Vertical Bone Loss
Time frame: Baseline to 6 months after surgery
Change in Horizontal Bone Loss.
Time frame: Baseline to 6 months after surgery
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 Sep 2026.
- 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 study testing Platelet rich fibrin and Emdogain in people with Peridontal Disease and Furcation Defects, run by Medical University of Sofia at 1 site in Bulgaria.
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 13 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 Sep 2026. 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 Bulgaria. 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?
Change in Horizontal Furcation Probing Depth (time frame: Baseline to 6 months after surgery). 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 25 Sep 2026.