Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOctober 6 University

About this trial

This study aims to compare the clinical and radiographic effectiveness of injectable platelet-rich fibrin (i-PRF) combined with minimally invasive non-surgical therapy (MINST) versus MINST alone in the management of class II furcation defects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of both genders >18 years old, medically free of systemic diseases affecting periodontal regeneration.

Diagnosis of stage III, grade B periodontitis (according to the AAP/EFP classification 2018) with the presence of class II furcation defect in either the maxillary (buccal) or mandibular arch (buccal or lingual) as determined by clinical evaluation and confirmed by radiographic evaluation.

Gingival margin and interdental bone positioned coronally to the furcation entrance.

Commitment to maintenance visits and follow-up.

Disqualifiers

Patients suffering from any systemic diseases that may affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc;

Patients that received periodontal surgical treatments in the past 12 months.

Smoking (current or in past 5 years)

Prolonged treatment with antibiotics or anti-inflammatory agents within 6 months prior to periodontal therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minimally invasive non-surgical technique (MINST)

    Procedure/Surgery

    Patients will receive minimally invasive non-surgical technique (MINST) alone

  • Minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection

    Procedure/Surgery

    Patients will receive minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Positive control groupActive comparator 1 intervention
Group B: Test groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Radiographic Bone Fill at the Furcation Site

Radiographic bone fill at the furcation site will be assessed using cone-beam computed tomography (CBCT). The analysis will include measurement of the filled bone volume (FBV) at the furcation area using segmentation.

Time frame
6 months after treatment

Secondary outcomes

1

Change in Horizontal Clinical Attachment Level

Horizontal clinical attachment level will be assessed using periodontal probing at baseline and 6 months after treatment.

Time frame
6 months after treatment
2

Change in Vertical Clinical Attachment Level

Vertical clinical attachment levels will be assessed using periodontal probing at baseline and 6 months after treatment.

Time frame
6 months after treatment
3

Change in Probing Pocket Depth

Probing pocket depth (PPD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at six sites per tooth using a UNC-15 periodontal probe. Measurements will be recorded at baseline and 6 months after treatment.

Time frame
6 months after treatment
4

Change in Gingival Margin Location

The location of the gingival margin will be assessed by measuring the distance from the cemento-enamel junction (CEJ) to the gingival margin. Measurements will be recorded at baseline and 6 months after treatment.

Time frame
6 months after treatment

Other outcomes

Sponsors and contacts

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