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

Summary

Rationale for conducting the research:

Bilateral alveolar clefts pose significant management challenges, with current treatments like autogenous bone grafting showing instability in up to 40% of cases within a year, risking graft failure and aesthetic issues . Prefabricated acrylic splints may offer a minimally invasive alternative, potentially improving bone graft outcomes and premaxillary stability, crucial for speech, feeding, and respiration. This study evaluates the efficacy of acrylic splinting versus traditional open healing, aiming to enhance patient outcomes and reduce healthcare costs associated with this congenital condition . This research underscores the need for evidence-based, minimally invasive treatments that can improve quality of life and guide clinical practices for managing bilateral alveolar clefts.

Review of literature:

The existing body of literature on bilateral alveolar clefts and their management reflects several inadequacies and gaps in the evidence base. Bilateral alveolar clefts present unique challenges that have not been fully addressed in the literature on cleft lip and palate management. Limited evidence suggests more focused research in this area. The prevailing treatment options for bilateral alveolar clefts predominantly involve surgical bone grafting procedures. These grafting techniques have shown varying success rates, with factors such as graft quality, surgical technique, and premaxillary stability influencing outcomes. However, the specific challenges posed by bilateral alveolar clefts have not been addressed comprehensively in the existing literature. While grafting procedures have undoubtedly improved the lives of countless patients, there remains a need for more targeted interventions that can enhance premaxillary stability and graft success, particularly in the context of bilateral alveolar clefts. The proposed use of prefabricated acrylic splints represents a novel and innovative approach to address these inadequacies. These splints are designed to provide consistent and reliable support to the premaxilla during the critical early phases of healing following grafting procedures. By minimizing premaxillary mobility, they have the potential to enhance graft success rates, improve premaxillary stability, and enhance the overall outcomes of bilateral alveolar cleft repairs.

Explanation for choice of comparators:

standard bone grafting without acrylic splints is considered the 'gold standard' for treating alveolar clefts. Using normal repair as the comparator allows for a clear assessment of the possible advantages and challenges of incorporating acrylic splints into existing best practices.

7\. Objectives:

Aim of the Study The primary aim of this study is to assess the impact of prefabricated acrylic splints on premaxillary stability, soft tissue healing, and graft stability in patients with bilateral alveolar clefts.

Hypothesis:

Null Hypothesis (H0): Bilateral alveolar cleft patients who receive prefabricated acrylic splints have similar premaxillary stability, soft tissue healing, and graft stability.

Alternative Hypothesis (H1): Prefabricated acrylic splints improve premaxillary stability, soft tissue healing, and graft stability in bilateral alveolar cleft patients.

The above hypotheses are neutral and not biased. The study tests these hypotheses to obtain objective and evidence-based conclusions about prefabricated acrylic splints for bilateral alveolar cleft repairs.

This randomized controlled trial will be conducted in Cairo hospital (Abu El-Reesh El-Mounira Children University Hospital). To ensure clinical facilities, medical expertise, and target patient access, this study will be conducted in a hospital. The population density of Cairo and prevalence of bilateral alveolar clefts make it ideal for this research . Cairo study sites will be available upon request and documented in the trial.

Interventions All surgical procedures will be conducted under general anesthesia with nasotracheal intubation, and a first-generation cephalosporin will be administered as antibiotic prophylaxis prior to incision. Autogenous bone grafts will be harvested from the anterior iliac crest using a pediatric minimally invasive technique, involving a 2 cm skin incision made 1 cm lateral to the iliac crest, meticulously dissected to preserve soft tissue. pain management strategies will be employed postoperatively to ensure comprehensive pain control and enhance patient comfort throughout the recovery period.

For the alveolar cleft repair, a sulcular incision will be made to develop full thickness mucoperiosteal advancement flaps extending into the cleft, with careful elevation of buccal flaps above the piriform rim. The bone graft will be contoured to fill the defect, ensuring cortical bone contacts the nasal lining and cancellous bone chips fill remaining spaces. Closure will be performed using interrupted sutures, starting with the nasal floor

Conditions

• Bilateral Complete Cleft Lip And/or Alveolus and Acrylic Splint, and
• Maxillary Deficiency
• Stability

Interventions

DEVICE

Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of using a custom-made prefabricated acrylic splint versus no splint in maintaining premaxillary stabilit

Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of using a custom-made prefabricated acrylic splint versus no splint in maintaining premaxillary stability post-alveolar cleft repair. Primary Outcome: Premaxillary stability. Secondary Outcomes: Wound healing and complications. Intervention Details 1\. Common Procedures for Both Arms: Surgical Procedure: All surgical procedures will be conducted under general anesthesia with nasotracheal intubation. Antibiotic Prophylaxis: A first-generation cephalosporin will be administered prior to incision as per . Bone Graft Harvesting: Autogenous bone grafts will be harvested from the anterior iliac crest using a pediatric minimally invasive technique with a 2 cm skin incision 1 cm lateral to the iliac crest. Alveolar Cleft Repair: Incision and Flap Design: A sulcular incision will be made to develop full thickness mucoperiosteal advancement flaps extending into the cleft with caref

Sponsors & Collaborators

• Cairo University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

9 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-20

Primary Completion

2025-05-30

Completion

2026-12-30