Mansoura University
Al Mansurah, Mansoura, 35516, Egypt
NCT Number: NCT06693349
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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Notify Me7 year–13 year
All sexes
Interventional
Phase 3
Al Mansurah, Mansoura, 35516, Egypt
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),
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
this procedure was anticipated to give superior effects than other procedure used in this study
Other names: platelet-rich fibrin revascularization
this procedure was anticipated to be replaced by other procedure be used in this study
Other names: calcium hydroxide apexification
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
Mohammed Nasser Alhajj
Other
Evaluation of Platelet-rich Fibrin for Revascularization of Im-mature Permanent Teeth Versus Standard Apexification: a 12-month Clinical Follow-up Study
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