NCT06451276

The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate

The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Alveolar Ridge, Nasal and Labial Growths in Children With Unilateral Cleft Lip and Palate

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 7 Days – 12 Weeks
• Healthy volunteers: Accepted

Summary

The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate. objectives: - 1. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point. 2. Evaluation of the nasal symmetry.

Detailed description

cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. Unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. Additionally, it predominantly affects males, with a male-to-female ratio of 2:1. Common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. Peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. Additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side. Conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. However, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. Therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. The introduction of the presurgical Nasoalveolar molding (NAM) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . These interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
DEVICE	Nasoalveolar molding in unilateral cleft lip and palate	compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-07-20
• Completion: 2025-08-20
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

2 sites across 1 country: Egypt