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| Name | Class |
|---|---|
| Mansoura University | OTHER |
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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
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' 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),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contaminated immature permanent teeth | Active Comparator | treatment of contaminated immature permanent teeth through either revascularization or apexification procedures |
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| uncontaminated immature permanent teeth | Active Comparator | treatment of uncontaminated immature permanent teeth through either revascularization or apexification procedures |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
• Patients were free of chronic systemic diseases.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | Mansoura | 35516 | Egypt |
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| 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 |
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