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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Device: Nasoalveolar molding in unilateral cleft lip and palate

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed F Ahmed, Master; Phone Number: 00201009050985; Email: Ahmedfarghly0@gmail.com
• Study Contact Backup: Name: Adel F Hassan, Phd; Phone Number: 00201124591323; Email: Adelfathy@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 4050113
    • Faculty of Dental Medicine
    • Contact: Ahmed Ahmed, Master; Phone Number: 00201009050985; Email: Ahmedfarghly0@gmail.com
    • Contact: Adel F Hassan, Phd
  • Cairo, Egypt, 4450113
    • Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University
    • Contact: Ahmed Ahmed, Master; Phone Number: +1917-528-5809; Email: Ahmedfarghly0@gmail.com
    • Contact: Adel Hassan, Phd; Phone Number: +201124591323; Email: Adelfathy@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adhesive nasoalveolar molding (GS-NAM); 3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D (3 dimensional ) printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm	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; Other Names: NAM
Experimental: Conventional nasoalveolar molding; (positive control group) comprises 10 cases of unilateral cleft lip and palate that will be scheduled for construction of 3D (3 dimensional ) printed conventional NAM in thickness of 2 mm. The cleft area will be blocked in software, and NAM will be fabricated using a 3D printer. Soft acrylic resin will be added to make pressure area and reduction in opposing for relief. The appliance will be evaluated and adjusted monthly. A nasal stent will be fabricated when the cleft is 5mm	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; Other Names: NAM
No Intervention: normal children; normal children which will be compared with groups 1 and 2 for results evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior ends of alveolar crest	width between the most posterior ends of the alveolar crest in the greater segment and lesser segment	3 months
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
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
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
Angulation of maxilla	Mid-Inc)-Sagittal: - Angle among Inc point, midpoint in PG -PL, and sagittal line	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Adel F Hassan, Phd, Fucalty of dental medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2024
• Primary Completion (Estimated): July 20, 2025
• Study Completion (Estimated): August 20, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: NAM in unilateral cleft

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 4 months
• IPD Sharing Access Criteria: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No