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Completed

NCT Number: NCT06693349

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

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

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Key information

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mansoura University

Al Mansurah, Mansoura, 35516, Egypt

About this study

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),

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the effect of platelet-rich fibrin in treatment of contaminated and uncontaminated immature permanent teeth

Drug

this procedure was anticipated to give superior effects than other procedure used in this study

Other names: platelet-rich fibrin revascularization

the effect of apexification in treatment of contaminated and uncontaminated immature permanent teeth

Drug

this procedure was anticipated to be replaced by other procedure be used in this study

Other names: calcium hydroxide apexification

Primary outcomes

  1. Radiographic measurements of the change in the canal space

    Time frame: 16 months

    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

Sponsors and collaborators

Lead sponsor

Mohammed Nasser Alhajj

Other

Collaborators

  • Mansoura University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.