A Phase 3 interventional study of Injectable-PRF (I-PRF) and sticky bone (I-PRF+Xenograft) in Class II Furcation Defect, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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
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.
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Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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)
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)
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.
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.
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
Time frame: at baseline,6 months,12 months follow up
linear bone fill
the linear bone fill will be assessed radiographically using periapical x-ray films by linear measurements in millimeters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at baseline, 6months &12months follow up
patient satisfaction
it is measured using visual analogue scale (VAS)
Time frame: 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
Time frame: 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.
Time frame: at baseline, 6months &12months follow up
Plan to share: No
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