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

NCT ID: NCT06693349

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2021-04-12

Brief Summary

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

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),

Conditions

To Evaluate the Clinical and Radiographic Effect of Platelet-rich Fibrin in Treatment of Necrotic Permanent Teeth with Open Apices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Contaminated immature permanent teeth

treatment of contaminated immature permanent teeth through either revascularization or apexification procedures

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

uncontaminated immature permanent teeth

treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

platelet-rich fibrin revascularization; calcium hydroxide apexification

Eligibility Criteria

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).

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: collaborator

Mohammed Nasser Alhajj

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Nasser Alhajj

Assistant Professor Dr. Mohammed Nasser Alhajj

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mansoura University

Al Mansurah, Mansoura, Egypt

Countries

Egypt

Other Identifiers

11111218

Identifier Type: -

Identifier Source: org_study_id