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

Evaluation of Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Grade II Furcation Defects: A Randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Minimally Invasive; Injectable Platelet-Rich Fibrin; Non-Surgical Technique; Grade II Furcation Defects
• Intervention / Treatment: Procedure: Minimally invasive non-surgical technique (MINST); Procedure: Minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection

Detailed Description

Periodontitis is a multifactorial inflammatory disease that occurs due to the challenge between the host response and specific periodontal pathogens, leading to a gradual destruction of the periodontal supporting tissues over time.

Different regenerative approaches have been proposed including guided tissue regeneration (GTR); bone grafts, bioactive agents such as enamel matrix derivative (EMD) and platelet concentrates.

Using the minimally invasive nonsurgical technique (MINST) implements magnification with microscope/loupes and delicate instruments, to perform the periodontal debridement with more effective root debridement and less soft tissue trauma. MINST significantly improve the visualization and root decontamination, and at the same time preserve the gingival margin and consequently improve the aesthetic results and tissue stability.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moustafa A Ahmed, B.D.S; Phone Number: 00201098378998; Email: 23110295.pg@o6u.edu.eg

Study Locations

• Egypt
  • Giza Governorate
    • Giza, Giza Governorate, Egypt, 12511
      • Recruiting
      • October 6 University (Faculty of Dentistry)
      • Sub-Investigator: Reham L Aggour, MD
      • Contact: Moustafa A Ahmed, B.D.S; Phone Number: 00201098378998; Email: 23110295.pg@o6u.edu.eg
      • Sub-Investigator: Shereen F Ahmed, MD
      • Sub-Investigator: Wessam I Shehab, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Absence of primary endodontic lesions.

Exclusion Criteria:

• 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.
• Pregnant and lactating females.
• Teeth with hopeless prognosis
• Third molars

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive control group; Patients will receive minimally invasive non-surgical technique (MINST) alone	Procedure: Minimally invasive non-surgical technique (MINST); Patients will receive minimally invasive non-surgical technique (MINST) alone
Experimental: Test group; Patients will receive minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection	Procedure: Minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection; Patients will receive minimally invasive non-surgical technique (MINST) + injectable platelet-rich fibrin (i-PRF) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Horizontal Clinical Attachment Level	Horizontal clinical attachment level will be assessed using periodontal probing at baseline and 6 months after treatment.	6 months after treatment
Change in Vertical Clinical Attachment Level	Vertical clinical attachment levels will be assessed using periodontal probing at baseline and 6 months after treatment.	6 months after treatment
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.	6 months after treatment
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.	6 months after treatment
Change in Plaque Index	Plaque index (PI) will be assessed to evaluate oral hygiene status by measuring dental plaque accumulation in areas adjacent to the gingival margin. Plaque index will be recorded at baseline and 6 months after treatment.	6 months after treatment
Change in Bleeding on Probing	Bleeding on probing (BoP) will be assessed by gently inserting a periodontal probe into the gingival sulcus at the base of the interdental papilla and recording the intensity of bleeding after a short delay. BoP will be assessed at baseline and 6 months after treatment.	6 months after treatment

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 11, 2027

Study Registration Dates

• First Submitted: August 23, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 23, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections; proliferation regulatory factors, human urine
• Other Study ID Numbers: 23110295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No