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

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451276
• Other study ID #: NAM in unilateral cleft
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2024
• Est. completion date: August 20, 2025

Study information

• Verified date: June 2024
• Source: Al-Azhar University
• Contact: Ahmed F Ahmed, Master
• Phone: 00201009050985
• Email: Ahmedfarghly0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 20, 2025
• Est. primary completion date: July 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of dental medicine	Cairo
Egypt	Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior ends of alveolar crest	width between the most posterior ends of the alveolar crest in the greater segment and lesser segment	3 months
Primary	Middle ends of alveolar crest	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	3 months
Primary	Anterior ends of alveolar crest	The widths of the cleft gap (The anterior endpoint of the alveolar crest in the greater and lesser segment)	3 months
Primary	Mid line of maxilla	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)	3 months
Primary	Angulation of maxilla	Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line	3 months
Secondary	Alar base width	Total width correction of alar base width.	3 months
Secondary	Columella length.	Columella length correction	3 months
Secondary	Columella angle deviation.	Columella angle deviation correction	3 months
Secondary	Nostril height and width on the cleft side.	Nostril height and width on the cleft side correction	3 months
Secondary	Nostril height and width on the non-cleft side	Nostril height and width on the non-cleft side correction	3 months
Secondary	Nasal ridge deviation.	Nasal ridge deviation correction	3 months