Evaluation of Platelet-rich Fibrin for Revascularization of Immature Permanent Teeth Versus Standard Apexification

Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study

The goal of this clinical trial is to evaluate the effect of platelet-rich fibrin for revascularization of immature permanent teeth in comparison to standard apexification using calcium hydroxide (as a 12 months follow up for previous study) through using clinical outcomes and radiographically using cone beam computed tomography the main questions it aims to answer are

• is the platelet-rich fibrin an effective mean for management of necrotic immature permanent teeth
• is the platelet-rich fibrin has a superior clinical and radiographic effects than calcium hydroxide apexification participants were treated either by platelet-rich fibrin revascularisation or calcium hydroxide apexification

Study Overview

• Status: Completed
• Conditions: To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices
• Intervention / Treatment: Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth; Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth

Detailed Description

This study is an extension of a previous study [12], encompassing a 12-month fol-low-up period. The protocol for this study received approval from the ethical committee of the Faculty of Dentistry at Mansoura University (11111218) as a randomized con-trolled-clinical trial with a 1:1 allocation ratio for groups and subgroups. The sample size for this study was calculated based on Nagy et al.'s study [13], which determined a re-quired sample size of 28 teeth.

Inclusion and diagnostic criteria:

A total of 28 children, including both boys and girls, were recruited through daily pa-tient screenings in the Clinics of Pediatric Dentistry and dental public health department, Faculty of Dentistry at Mansoura University, following specific inclusion and diagnostic criteria:

• Patients were free of chronic systemic diseases.
• Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
• Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
• Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).

Patients' allocation:

The included 28 children were divided into two main groups, each consisting of 14 children: Group I (contaminated teeth) and Group II (uncontaminated teeth). Within each group, children were further divided into two subgroups based on the treatment tech-nique. The allocation was determined through simple randomization, resulting in a Platelet-Rich Fibrin subgroup (n=7 for each) and a Calcium Hydroxide (CH) apexification subgroups (control) (n=7 for each),

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Patients were free of chronic systemic diseases.

  • Clinically, a negative response to electric pulp sensibility testing confirmed the pres-ence of immature necrotic permanent teeth.
  • Teeth were categorized as uncontaminated if, during the examination, there were no signs of pain, no tenderness during apical percussion, no tenderness of adjacent soft tissues, and no history of open sinus, fistula or swelling.
  • Radiographically, teeth were with roots exhibiting thin dentin walls and open apical foramina larger than 1 mm, along with apical periodontitis (considered as contami-nated) or without apical periodontitis (considered as uncontaminated).

Exclusion Criteria:

• other than inclusion criteria

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Contaminated immature permanent teeth; treatment of contaminated immature permanent teeth through either revascularization or apexification procedures	Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth; this procedure was anticipated to give superior effects than other procedure used in this study; Other Names: platelet-rich fibrin revascularization; Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth; this procedure was anticipated to be replaced by other procedure be used in this study; Other Names: calcium hydroxide apexification
Active Comparator: uncontaminated immature permanent teeth; treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures	Drug: the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth; this procedure was anticipated to give superior effects than other procedure used in this study; Other Names: platelet-rich fibrin revascularization; Drug: the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth; this procedure was anticipated to be replaced by other procedure be used in this study; Other Names: calcium hydroxide apexification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic measurements of the change in the canal space	Radiographic measurements of the change in the canal space, including an increase in root length and thickness, and reduction in a diameter of the apical foramen, were conducted using the CBCT	16 months

Collaborators and Investigators

• Sponsor: Mohammed Nasser Alhajj
• Collaborators: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: platelet-rich fibrin, revascularization, apexification
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Calcium
• Other Study ID Numbers: 11111218

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
• product manufactured in and exported from the U.S.: No