Injectable Platelet-Rich Fibrin With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects

Injectable Platelet-Rich Fibrin (i-PRF) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial

This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Intrabony Defects; Platelet-Rich Fibrin; Minimally Invasive Non-Surgical Technique
• Intervention / Treatment: Procedure: Minimally invasive non-Surgical technique; Procedure: Minimally invasive non-Surgical technique + platelet-rich fibrin

Detailed Description

Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the periodontal supporting tissues, ultimately leading to tooth loss if left untreated.

Optimal periodontal regeneration within intrabony defects depends on the preservation of soft tissues and the maintenance of primary wound closure. Minimally invasive non-surgical periodontal therapy (MINST) has been introduced as a concept aiming to obtain extensive subgingival debridement with minimal tissue trauma.

Platelet-rich plasma (PRP) is an autologous blood product which is created through the centrifugation process of whole blood. It is defined as having a platelet concentration above that of normal physiological levels. The platelets present in PRP carry granules containing a significant number of active biomolecules.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir R Elngar, B.D.S; Phone Number: 00201004634587; Email: amirreda059@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12511
    • Recruiting
    • October 6 University
    • Contact: Amir R Elngar, B.D.S; Phone Number: 00201004634587; Email: amirreda059@gmail.com
    • Sub-Investigator: Reham L Aggour, MD
    • Sub-Investigator: Amany A Alaraby, 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 'periodontitis' stage III (grades B or C).
• Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
• Presence of comparable bilateral two- or three-walled intrabony defects [probing pocket depth (PPD), > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph] not in a furcation-involved tooth.

Exclusion Criteria:

• Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
• Pregnant and lactating women
• Current use of any form of tobacco.
• Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
• Degree 2 or 3 mobility of the involved sites.6.
• Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.

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: Group 1 (control group); Patients will receive minimally invasive non-Surgical technique (MINST) alone	Procedure: Minimally invasive non-Surgical technique; Patients will receive minimally invasive non-Surgical technique (MINST) alone
Experimental: Group 2 (Test group); Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection	Procedure: Minimally invasive non-Surgical technique + platelet-rich fibrin; 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
Presence of comparable bilateral-walled intrabony defects	Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, > 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	Clinical attachment level (CAL) will be measured in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal sulcus at 6 sites per tooth	6 months postoperatively
Interproximal probing depth	Probing depth (PD) will be measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth	6 months postoperatively
Gingival margin	Gingival margin will be measured from the cemento-enamel junction (CEJ).	6 months postoperatively
Bleeding on probing	Bleeding on Probing (BoP) will be measured using papillary bleeding index that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus	6 months postoperatively
Plaque index	Plaque index (PI) will be measured for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin	6 months postoperatively

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23110280p

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