Class II Furcation DefectPhase 3NCT07876973
Treatment of Class II Mandibular Furcation Defects
A Phase 3 study testing Injectable-PRF (I-PRF) and sticky bone (I-PRF+Xenograft) in people with Class II Furcation Defect, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the clinical efficiency and radiographic outcomes following minimally invasive surgical technique with xenograft and i-PRF versus i-PRF in the management of class II furcation defects in mandibular molars Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Class II Furcation Defect
- What is being tested?
- Injectable-PRF (I-PRF) and sticky bone (I-PRF+Xenograft)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with healthy systemic condition
- Adult patients (18 years old and older)
- Patients with stage lll or IV periodontitis.
- Patients having a buccal or lingual degree II A or B furcation defect in periapical-lesion free and not mobile first or second mandibular molars with horizontal attachment loss HCAL >3 mm and probing depth PD ≥5 mm in the mid-buccal or mid-lingual sites when evaluated 12 weeks after non-surgical periodontal therapy.
- Patients with full mouth plaque score<10% on the day of the surgery.
- Patients with full mouth bleeding score<10% on the day of the surgery.
Show all 9Show fewer
- Compliance with good oral hygiene.
- Patients accept 12-months follow-up period (cooperative patients).
- Patients provide an informed consent.
Who cannot join
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- Defects that involve the buccal and lingual sites.
- Smokers ˃ 10 cigarettes / day
- Pregnant and lactating female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alhussien A Ahmed mohamed, master candidate contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry,Cairo University
Cairo, Cairo Governorate, 35855
Manal M Hosny, professor, 00201118459362, manal.hosny@dentistry.cu.edu.eg
Karim F Elsayed, professor, 00201005444050, Karim.fawzy@dentistry.cu.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of Minimally Invasive Surgical Technique With Xenograft and Injectable Platelet Rich Fibrin Versus Injectable Platelet Rich Fibrin Alone in the Treatment of Class II Mandibular Furcation Defects: A Randomized Clinical Trial
The aim of this study is to investigate the clinical efficiency and radiographic outcomes following minimally invasive surgical technique with xenograft and i-PRF versus i-PRF in the management of class II furcation defects in mandibular molars
Read the detailed description
Periodontitis is a chronic inflammatory disease characterized by progressive destruction of the tooth-supporting tissues. Its primary features include the loss of periodontal tissue support manifested as clinical attachment loss (CAL), presence of periodontal pocketing, furcation involvement and radiographically assessed alveolar bone loss. Untreated or inadequately treated periodontitis may lead to tooth loss . When teeth with furcation defects are involved, they exhibit a higher tooth loss rate, where the percentage of molar loss increased gradually for degree I (13.5% for upper and 11.8% for lower molars), degree II (34.8% for upper and 32.9% for lower molars) and degree III FI (53.3% for upper and 60.0% for lower molars) . Furcation area has a complex anatomic morphology that may be difficult or impossible to debride during routine periodontal instrumentation and routine home care methods also may not keep the furcation area free of plaque . The aim of periodontal treatment is to arrest disease progression by reducing the bacterial load and to reduce the risk of tooth loss, as well as to prevent disease recurrence, even in restricted access areas, such as furcation defects. Non-responding sites may be treated with repeated subgingival instrumentation with or without adjunctive therapies or surgically following the protocols of access flap, resective, or regenerative periodontal surgery. Treatment of teeth with furcation involvement ranges from thorough debridement to regenerative procedures and to extraction if the prognosis is hopeless . A recent systematic review concluded that no gold standard can be established for the regenerative treatment of class II furcation involvement and further research is recommended .
Rationale for conducting the research:
In order to treat periodontitis, several procedures have been proposed to regenerate the lost periodontal tissues, including guided tissue regeneration (GTR), bone graft placement, and the use of bioactive agents, such as growth factors , despite having several drawbacks.
Periodontal regeneration is a highly predictable therapeutic option for the treatment of class II furcation involvement of lower molars, concluded that a combined therapeutic approach associating bone grafts with membranes/biological agents produces better results than monotherapeutic treatments . The advent use of i-PRF with bone graft showed significant improvements, better than using bone grafts solely . The combination of bone graft and I-PRF results in higher bone height and higher percentages of new vital bone compared to using bone graft alone . I-PRF possess the advantage of exhibiting constant release of growth factors as well as promoting cell migration by announcing the expression of type I collagen and transforming growth factor mRNA.
.
- Conditions
- Class II Furcation Defect
- Being tested
- Injectable-PRF (I-PRF), sticky bone (I-PRF+Xenograft)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable-PRF (I-PRF)Biological
I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately).
The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.
sticky bone (I-PRF+Xenograft)Biological
The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect.
The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area.
| Study group | Role | What they receive |
|---|---|---|
| Injectable-PRF (I-PRF) | Experimental | I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately).
The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. Receives: Biological: Injectable-PRF (I-PRF) |
| sticky bone (I-PRF+Xenograft) | Active comparator | The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect.
The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. Receives: Biological: sticky bone (I-PRF+Xenograft) |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in probing depth
It is measured in milimeters using UNC 15 periodontal probe that inserted in the buccal gingival sulcus in the area corresponding to the furcation defect with a force not exceed 25 g
Measured: at baseline,6 months,12 months follow up
Secondary outcomes (7)
linear bone fill
the linear bone fill will be assessed radiographically using periapical x-ray films by linear measurements in millimeters
Measured: at baseline,6 months,12 months follow up
clinical attachment level gain (CAL gain)
it is measured in millimeters using UNC 15 periodontal probe from a fixed reference point which is the cement-enamel junction to the base of the periodontal pocket
Measured: at 6 months and 12 months follow up
plaque index
it is measured according to Silness \& Loe PI , PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically.
PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental spaces
Measured: at baseline, 6months &12months follow up
Horizontal probing pocket depth
it is measured in millimeters using UNC 15 periodontal probe by inserting it horizontally in the furcation area and measure the distance from gingival margin to deepest part of the furcation defect
Measured: at baseline, 6months &12months follow up
patient satisfaction
it is measured using visual analogue scale (VAS)
Measured: at baseline, 6months &12months follow up.
Gingival recession
it is measured in millimeters using UNC 15 periodontal probe from a fixed reference point which is the cement-enamel junction to the gingival margin
Measured: at baseline, 6months &12months follow up
Bleeding on probing
it is measured by inserting the periodontal probe about 1mm inside the gingival sulcus and moving it between the line angles of the tooth .if that induce bleeding within 10 seconds these point considered positive for bleeding.
it is measured at 3 points in the buccal sulcus and 3 points in lingual sulcus.
Measured: at baseline, 6months &12months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Furcation DefectStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alhussien abdelmonem ahmed mohamed, Cairo University
- Investigators
- Alhussien A Ahmed mohamed, Master candidate, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876973
- Sponsor's protocol ID
- mandibular FI defect treatment
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Minimally Invasive Surgical Technique With Xenograft and Injectable Platelet Rich Fibrin Versus Injectable Platelet Rich Fibrin Alone in the Treatment of Class II Mandibular Furcation Defects: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07876973
- Acronym / sponsor ID
- mandibular FI defect treatment
- Conditions
- Class II Furcation Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Oct 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.
The aim of this study is to investigate the clinical efficiency and radiographic outcomes following minimally invasive surgical technique with xenograft and i-PRF versus i-PRF in the management of class II furcation defects in mandibular molars
Detailed description
Periodontitis is a chronic inflammatory disease characterized by progressive destruction of the tooth-supporting tissues. Its primary features include the loss of periodontal tissue support manifested as clinical attachment loss (CAL), presence of periodontal pocketing, furcation involvement and radiographically assessed alveolar bone loss. Untreated or inadequately treated periodontitis may lead to tooth loss . When teeth with furcation defects are involved, they exhibit a higher tooth loss rate, where the percentage of molar loss increased gradually for degree I (13.5% for upper and 11.8% for lower molars), degree II (34.8% for upper and 32.9% for lower molars) and degree III FI (53.3% for upper and 60.0% for lower molars) . Furcation area has a complex anatomic morphology that may be difficult or impossible to debride during routine periodontal instrumentation and routine home care methods also may not keep the furcation area free of plaque . The aim of periodontal treatment is to arrest disease progression by reducing the bacterial load and to reduce the risk of tooth loss, as well as to prevent disease recurrence, even in restricted access areas, such as furcation defects. Non-responding sites may be treated with repeated subgingival instrumentation with or without adjunctive therapies or surgically following the protocols of access flap, resective, or regenerative periodontal surgery. Treatment of teeth with furcation involvement ranges from thorough debridement to regenerative procedures and to extraction if the prognosis is hopeless . A recent systematic review concluded that no gold standard can be established for the regenerative treatment of class II furcation involvement and further research is recommended .
Rationale for conducting the research:
In order to treat periodontitis, several procedures have been proposed to regenerate the lost periodontal tissues, including guided tissue regeneration (GTR), bone graft placement, and the use of bioactive agents, such as growth factors , despite having several drawbacks.
Periodontal regeneration is a highly predictable therapeutic option for the treatment of class II furcation involvement of lower molars, concluded that a combined therapeutic approach associating bone grafts with membranes/biological agents produces better results than monotherapeutic treatments . The advent use of i-PRF with bone graft showed significant improvements, better than using bone grafts solely . The combination of bone graft and I-PRF results in higher bone height and higher percentages of new vital bone compared to using bone graft alone . I-PRF possess the advantage of exhibiting constant release of growth factors as well as promoting cell migration by announcing the expression of type I collagen and transforming growth factor mRNA.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable-PRF (I-PRF) | Experimental | Biological: Injectable-PRF (I-PRF)I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately). The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. |
| sticky bone (I-PRF+Xenograft) | Active comparator | Biological: sticky bone (I-PRF+Xenograft)The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect. The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with healthy systemic condition
- Adult patients (18 years old and older)
- Patients with stage lll or IV periodontitis.
- Patients having a buccal or lingual degree II A or B furcation defect in periapical-lesion free and not mobile first or second mandibular molars with horizontal attachment loss HCAL >3 mm and probing depth PD ≥5 mm in the mid-buccal or mid-lingual sites when evaluated 12 weeks after non-surgical periodontal therapy.
- Patients with full mouth plaque score<10% on the day of the surgery.
Key exclusion criteria (4 listed)
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- Defects that involve the buccal and lingual sites.
- Smokers ˃ 10 cigarettes / day
- Pregnant and lactating female
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 |
|---|---|---|
| Injectable-PRF (I-PRF)I-PRF will be prepared as follows: (Choukran et al., 2018) i-PRF was prepared by Choukroun's method. A total of 10 mL of venous blood was withdrawn from the patient and was immediately centrifuged for 3 min at 700 rpm in the centrifuge. The liquid in the top of the tube is obtained after centrifugation was collected using a blunt ended syringe. A limited amount of i-PRF was obtained from 10 mL of blood sample (1mL approximately). The injectable platelet rich fibrin will be injected into the defect Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. | Biological | Injectable-PRF (I-PRF) |
| sticky bone (I-PRF+Xenograft)The xenograft will be obtained and mixed with i-PRF. Mixing of xenograft and injectable platelet rich fibrin to get sticky bone graft that will be easily placed into the defect. The flap will approximated and Microsurgical suturing technique with 5or 6-0 monofilament polypropylene suture materials will be performed for optimal wound closure of the surgical area. | Biological | sticky bone (I-PRF+Xenograft) |
Primary outcome
difference in probing depth
Time frame: at baseline,6 months,12 months follow up
It is measured in milimeters using UNC 15 periodontal probe that inserted in the buccal gingival sulcus in the area corresponding to the furcation defect with a force not exceed 25 g
7 secondary outcomes
linear bone fill
Time frame: at baseline,6 months,12 months follow up
clinical attachment level gain (CAL gain)
Time frame: at 6 months and 12 months follow up
plaque index
Time frame: at baseline, 6months &12months follow up
Horizontal probing pocket depth
Time frame: at baseline, 6months &12months follow up
patient satisfaction
Time frame: at baseline, 6months &12months follow up.
Gingival recession
Time frame: at baseline, 6months &12months follow up
Bleeding on probing
Time frame: at baseline, 6months &12months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Class II Furcation Defect
Recruiting
Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects
Class II Furcation Defect
Active, not recruiting
Bovine Pericardium Membrane Versus Native Collagen Membrane in Conjunction With Sticky Bone Graft in Treatment of Class II Furcation Defects in Lower Molars.
Furcation Defects
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.
Alhussien A Ahmed mohamed, master candidate contact
Alhussien A Ahmed mohamed, Master candidate principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injectable-PRF (I-PRF) and sticky bone (I-PRF+Xenograft) in people with Class II Furcation Defect, run by Cairo University at 1 site in Egypt.
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 9 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: looking for participants now, as of the sponsor's last update on 15 Oct 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alhussien A Ahmed mohamed, master candidate (00201014788705, alhussien.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in probing depth (time frame: at baseline,6 months,12 months follow up). 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 15 Oct 2026.