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Recruiting NCT07613606

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

No phase Interventional Platelet-Rich Fibrin Minimally Invasive Non-Surgical Technique Periodontal Intrabony Defects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Minimally invasive non-Surgical technique, Minimally invasive non-Surgical technique + platelet-rich fibrin.
Who it may be relevant to
Registry conditions: Platelet-Rich Fibrin, Minimally Invasive Non-Surgical Technique, Periodontal Intrabony Defects. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Procedure Minimally invasive non-Surgical technique
    Patients will receive minimally invasive non-Surgical technique (MINST) alone
  • 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

Primary outcome measures

  • Presence of comparable bilateral-walled intrabony defects [Time frame: 6 months postoperatively]
Secondary outcome measures (5)
  • Clinical attachment level [Time frame: 6 months postoperatively]
  • Interproximal probing depth [Time frame: 6 months postoperatively]
  • Gingival margin [Time frame: 6 months postoperatively]
  • Bleeding on probing [Time frame: 6 months postoperatively]
  • Plaque index [Time frame: 6 months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • October 6 University — Cairo

Identifiers

NCT: NCT07613606 · 23110280p

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗