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

NCT06807645 | Not Yet Recruiting DMC

• 2 other identifiers: OMFS3-3-8CairoU
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary outcome should be: Premaxillary stability vertical and horizontal assessed by (Lateral Cephalometric Analysis (Radiographically) at 6 months: Perform lateral cephalometric analysis using images generated from Cone Beam Computed Tomography (

  Primary Outcome Measure: Outcome Measure Name: Premaxillary Stability Description: Assess the stability of the premaxilla both vertically and horizontally. Assessment Method: Lateral Cephalometric Analysis using images from Cone Beam Computed Tomography (CBCT). Time Frame: 6 months post-procedure. Units of Measure: Stability will be quantified in millimeters (mm) for both vertical and horizontal displacements.

  6 MONTHS

Secondary Outcomes (1)

• Secondary Outcome Measures: Outcome Measure Name: 1) Soft Tissue Healing 2) Outcome Measure Name: Graft Stability

  6 MONTHS

Other Outcomes (1)

• Stability will be quantified in millimeters (mm) for both vertical and horizontal displacements.

  6 MONTHS

Study Arms (1)

Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of us

EXPERIMENTAL

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 Bowder et al. (2021). 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 care

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

Interventions

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 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 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

Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of us

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Patients diagnosed with bilateral alveolar clefts.
• Age 8- 12 within the specified range.
• Willingness to comply with trial requirements.
• Patients with allergy use acrylic splints.
• Severe medical conditions such as mental retardation.
• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

alhussain, master

CONTACT

00201099624384; Majidah.abdullah@dentisry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: I have 2 group, partipant will have the intervention another no.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Bowder et al. (2021). 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

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 4, 2025
• Study Start: February 20, 2025
• Primary Completion: May 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02