Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin

February 7, 2024 updated by: Samah Mohsen Kanzel, Cairo University

Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin Versus Root Canal Treatment in Mature Permanent Molars With Apical Periodontitis: A Randomized Controlled Pilot Study

Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized pilot study, parallel groups design with 1:1 allocation ratio.

PICOT:

Population: Mature first permanent molar with apical periodontitis. Intervention: Regeneration using injectable platelet-rich fibrin. Control: Root canal treatment using GP obturation. outcomes: clinical and radiographic success. Source of patients: this study will be conducted in the outpatient postgraduate clinic of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt.

Written Informed consent from participating children/parents. Baseline records photographs, clinical inspection, percussion test, periapical radiograph, and personal data collection will be conducted.

A diagnostic chart with personal, medical, and dental history will be filled Diagnosis and treatment of the cases will be performed according to the Treatment Standards of the American Association of Endodontists (AAE) 2020 of Non-Surgical Endodontics for the Uncomplicated Mature Permanent Teeth.

Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of treatment then writing the patient's name and I.D. on it and will be opened in the next visit).

The radiographic examination will be performed by taking a periapical X-ray using (a parallel technique) to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any vertical dimension distortion and provide reproducible images using an X-ray holding device.

An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.

Intra-operative procedure:

First appointment:

  • Local anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000 using inferior alveolar nerve block.
  • Rubber dam will be applied, then caries removal and access cavity preparation will be established using a sterile carbide bur no. 8, and Endo Z bur.
  • Initial canal exploration will be performed with Endo Probe and no. 10 K-file to gauge canal size, shape, and configuration. Working length will be determined using an apex locator with no 15-hand K-file that will be kept 0.3 mm short of the radiographic apex and will be confirmed radiographically.
  • Then, the root canal preparation will be done as follows:

Rotary instrumentation will be preceded by manual hand instrumentation using no 20 K-file to check the patency. Then, the rotary instrumentation will be done using rotary files.

EDTA gel will be used as a lubricating paste during canal preparation with rotary files.

Sodium hypochlorite (1.5%) and saline irrigation using a side vented needle into the apical third of the canal to remove debris with copious irrigation using ultrasonic irrigation.

Dryness will be done using paper points size 30. The root canal will be filled homogeneously to the working length with Calcium Hydroxide paste (Metapaste), then, a small Teflon will be applied above the orifices and the tooth will be temporarily restored with Glass Ionomer restorative material till the next appointment.

Second appointment:

All the patients will be recalled after 3 weeks, if the symptoms are suggestive of persistent infection, the root canals will be re-irrigated with sodium hypochlorite followed by saline, and reinjected with calcium hydroxide paste. If the symptoms are relieved, patients will proceed to the next step.

  • A 1.8-mL of articaine 4% with epinephrine 1:100000 will be administered as inferior alveolar nerve block. The rubber dam will be placed, and the glass ionomer cement and Teflon will be removed. The root canals will be agitated with master apical K-file and re-irrigated using 17% EDTA solution followed by saline irrigation, then the canals will be dried using a paper point.
  • For the intervention group, I-PRF Regeneration will be applied.
  • For the control group, root canal treatment will be applied.

C) Follow up:

Clinical evaluation will be performed on 1, 3, 6, 9, and 12 months post-operatively.

Radiographic evaluation will be performed pre-operatively (baseline), and postoperative following the second appointment at 6, and 12 months using the individualized XCP (Extension Cone Paralleling) index and the Digital X-ray machine.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children aged between 10-15 years.
  2. First Permanent molar diagnosed with apical periodontitis.
  3. A cooperative and compliant patient/ parent.
  4. Patients not allergic to medicaments necessary to complete the procedure.
  5. Patients with no history of chronic systemic diseases.

Exclusion Criteria:

  1. Teeth indicated for post and core.
  2. Non-restorable tooth.
  3. Previous root canal treatment.
  4. Curved canal of more than 25°.
  5. Periodontal pocket larger than 3 mm.
  6. Teeth with developmental anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regeneration using Injectable platelet-rich fibrin
A 10-mL sample of whole venous blood will be drawn from the patient's forearm (median cubital vein). It will be centrifuged immediately by a tabletop centrifuge at 700 rpm for 3 minutes at room temperature. Injectable platelet-rich fibrin (I-PRF) will be collected. After that, the I-PRF will be injected inside the canals using a plastic syringe needle that will be placed 1mm short of the working length and withdrawn gradually while injecting till reaching the orifices of the canals. After that, a Collagen membrane matrix will be placed above the canal orifice and will left for 5 minutes to partially harden, then a 3 mm thick layer of MTA will be placed directly over it. The cavity will be sealed with composite and covered with a stainless steel crown.
Procedure: Regeneration using Injectable platelet-rich fibrin
root canals of affected molars will be cleaned and shaped chemo-mechanically, after two weeks I-PRF will be applied.
Active Comparator: Root canal treatment
The root canal will be obturated with gutta-percha by the cold lateral condensation technique with epoxy resin-based root canal sealer, the cavity will be sealed with composite and covered with a stainless steel crown.
Procedure: Root canal treatment
Conventional root canal treatment using gutta-percha obturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 1, 3, 6, 9 and 12 months

Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria:

Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.

Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success
Time Frame: 6 and 12 months

The scores will be follow:

  1. Absence of the periapical lesion; if the postoperative radiographic periodontal space is smaller than 0.5 mm.
  2. Reduction of the periapical lesion; if the postoperative radiographic lesion is smaller than approximately 20% of the preoperative radiographic lesion.
  3. Enlargement of the periapical lesion; if the postoperative radiographic lesion is bigger than approximately 20% of the preoperative radiographic lesion.
  4. Uncertain: if the case cannot be defined as absence, reduction, or enlargement of the periapical lesion, periapical rarefaction 1 mm or less, extraction of tooth before recall because of reasons not related to outcome of endodontic treatment.
6 and 12 months
Overall success
Time Frame: 6 and 12 months
The treatment will be scored as Success in case there is absence or reduction of the radiolucency (score 1 or 2), in addition to being clinically asymptomatic with no sinus tract, swelling, with no spontaneous, palpation, or percussions pain. On the other side, if the case showed a score of 3 or 4 radiographically or a symptomatic tooth, the case was recorded as Failure.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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