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

Not Applicable

Not yet recruiting

• Conditions: Cleft Lip and Palate

• Registration Number: NCT06451276
• Lead Sponsor: Al-Azhar University

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-31
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-07-20
• Primary Completion: 2025-07-20
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age: 1- 8 weeks.
• Gender: male and female.
• Patients with a unilateral cleft alveolus and lip.
• No developmental syndromes or atypical cleft pathology in medical history.
• No previous history of unilateral CLP correction.
• Motivated parents toward the treatment.

Exclusion Criteria

• Patients with a bilateral cleft alveolus and lip
• Syndromic patient
• Uncooperative caregiver

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Posterior ends of alveolar crest	3 months	width between the most posterior ends of the alveolar crest in the greater segment and lesser segment
Mid line of maxilla	3 months	Inc-Sagittal: - Perpendicular distance from Inc point (The intersection points between the labial frenum-incisive papilla point line and the alveolar crest of the premaxilla in the greater segment) to sagittal line (The perpendicular line to the PG-PL line)
Middle ends of alveolar crest	3 months	width between the middle parts of the cleft palate (The intersection points between the palatally extended buccal frenum sulcus line and the palatal gingival groove in the greater and lesser segment
Angulation of maxilla	3 months	Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line
Anterior ends of alveolar crest	3 months	The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)

Secondary Outcome Measures

Name	Time	Method
Alar base width	3 months	Total width correction of alar base width.
Columella angle deviation.	3 months	Columella angle deviation correction
Columella length.	3 months	Columella length correction
Nostril height and width on the cleft side.	3 months	Nostril height and width on the cleft side correction
Nostril height and width on the non-cleft side	3 months	Nostril height and width on the non-cleft side correction
Nasal ridge deviation.	3 months	Nasal ridge deviation correction

Trial Locations

Locations (2)

Faculty of dental medicine; 🇪🇬 Cairo, Egypt

Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University; 🇪🇬 Cairo, Egypt