Evaluating the Impact of Prefabricated Acrylic Splints on Premaxillary Stability in Alveolar Cleft Bone Graft Repairs: a Randomized Controlled Trial

Launched by CAIRO UNIVERSITY · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether prefabricated acrylic splints can improve healing and stability for children with bilateral alveolar clefts, a condition where there is a gap in the upper lip and jaw. The goal is to see if these splints can provide better support than traditional treatment methods, which often involve bone grafts but can sometimes lead to complications or instability within a year. The researchers hope that using these splints might help make the healing process more effective, leading to better outcomes in terms of speech, feeding, and overall quality of life.

To participate in this study, children aged 8 to 12 with a diagnosis of bilateral alveolar clefts can be eligible, as long as they do not have allergies to acrylic materials or other serious medical conditions. Parents can expect their children to undergo surgery under general anesthesia, where the team will carefully perform the necessary repairs and provide pain management afterward. The trial is being held at Abu El-Reesh El-Mounira Children University Hospital in Cairo, and the results could help improve treatment practices for this condition in the future.

Gender

ALL

Eligibility criteria

• Eligibility criteria:
• • A suitable and representative sample will be selected by setting trial participant eligibility criteria. Mesa et al (2016) claimed that, the inclusion and exclusion criteria will consider demographics, disease severity, prior treatment, diagnostics, and other factors. This trial must balance accurately representing the target population with avoiding overly restrictive selection criteria.
• • Inclusion Criteria
• • 1. Patients diagnosed with bilateral alveolar clefts.
• • 2. Age 8- 12 within the specified range.
• • 3. Willingness to comply with trial requirements.
• • Exclusion Criteria
• • 1. Patients with allergy use acrylic splints.
• • 2. Severe medical conditions such as mental retardation.
• • 3. Inability to provide informed consent or assent.
• • Operator-dependent interventions will have clear eligibility criteria for care providers and centers to ensure consistency in administration. To improve external validity and clinical applicability, the trial will avoid overly restrictive participant selection (Sessler \& Imrey 2015; Aggarwal \& Ranganathan 2019). To ensure generalizability, trial participants must reflect the diversity of the target population.