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CompletedNCT04606719Updated Feb 20, 2024

Healing Potentiality Of Blood Clot S-PRF and A-PRF in the Treatment Of Necrotic Mature Single-Rooted Teeth With Chronic Peri-Apical Periodontitis

An interventional study of Advanced Platelet Rich fibrin in Necrotic Pulp, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

Earlier, it was believed that successful regeneration cannot be achieved once tooth has become infected. However, recent studies suggest that regenerative endodontics may in fact be possible in teeth with pulpal necrosis and periapical pathology.

The primary goal in regenerative procedure is to eliminate clinical symptoms and resolve apical periodontitis. The blood clot acts as a scaffold, and the growth factors inside recruit stem cells, most likely from periapical papilla. But unfortunately, the erythrocytes in the clot of the blood column undergo necrosis, affecting its properties so the blood column is augmented by the use of different types of scaffolds.

Platelet-rich fibrin is classified into four types (Standard PRF, Injectable PRF, Advanced PRF and Concentrated Growth Factor CGF) according to speed and time of centrifuge with the overall aim to increase the number of platelets and leucocytes

02

Conditions studied

  • Necrotic Pulp

Keywords

  • Regeneration . Necrotic . Mature teeth . Blood clot . PRF
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 57 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Medically free patients who accept to participate in the study.
  • Age between 18-35 years old with no sex predilection.
  • Patients with good oral hygiene.
  • Patients with necrotic pulp in mandibular \& maxillary single rooted permanent teeth with mature apex that Symptomatic or Asymptomatic , Doesn't respond positively with the electric pulp tester ,Associated with or without swelling /sinus tract, Has radiographic evidence of periapical radiolucency, Has a straight, non-curved root, Teeth with normal occlusal contact with the opposing teeth.

Exclusion criteria

Exclusion Criteria:

  • Illiterate patient because they can't estimate the pain level on the pain scale (NRS).
  • Patients with systemic diseases or on systemic corticosteroids therapy because they have impaired healing and higher incidence of pain.
  • Pregnant women to avoid radiation exposure during the treatment which may be hazardous to the fetus and breasts from dental X-ray examinations shields.
  • Patients that have allergy to ciprofloxacin or metronidazole to avoid any allergic reaction after placement of bi-antibiotic paste as intra-canal medication.
  • Patients reporting bruxism or clenching because this induce more pressure on teeth and may initiate the post-operative pain in the treated tooth which is already have peri-apical inflammation
  • Teeth that, Have vertical root fracture, coronal perforation, and calcification, Are indicated for retreatment because they have lower success rate , Have pocket depth greater than 5mm,Need periodontal therapy , Non restorable , Hopeless tooth, patients that have T.M.J disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Other
    Blood Clot

    It is induced through apical foramen by penetrating the periapical area by stainless steel file size 30 to fill the root canal system by growth factors also to be considered as scaffold

    Procedure: Advanced Platelet Rich fibrin

  • Active comparator
    Standard PRF

    Standard Platelet-rich fibrin will be prepared by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 3000 rpm for 10 min. After centrifugation, three layers will formed in the test tube-base layer of RBCs, top layer of a-cellular plasma, and a PRF clot in the middle. This clot will then pressed between two gauze pieces to form a membrane.

    Procedure: Advanced Platelet Rich fibrin

  • Experimental
    Advanced PRF

    A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes

    Procedure: Advanced Platelet Rich fibrin

Interventions

  • ProcedureAdvanced Platelet Rich fibrin

    Preparing of A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes

06

What researchers measure

Primary outcomes

  1. healing Rate

    standardized digital radiograph

    Time frame: follow up to 6 months

Secondary outcomes

  1. Postoperative pain: NRS

    using neumerical rationg scale NRS . from zero to 10 . zero = no pain 1 to 3 = mild 4-6 = moderate 7-10 = severe

    Time frame: up to one year

  2. sensitivty

    using sensitivity tests

    Time frame: 6 months to one year

07

Study locations

1 site
  • Cairo University
    Cairo, 12345, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04606719
Lead sponsor
Cairo University
Responsible party
Omnia Badawy Darwish (Principal Investigator, Cairo University) — Principal investigator
First posted
Oct 28, 2020
Start date
Sep 1, 2021
Primary completion
Sep 1, 2022
Completion
Sep 1, 2023
Last update
Feb 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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