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

NCT06451276 | Not Yet Recruiting DMC

• 1 other identifier: NAM in unilateral cleft
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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. 1.Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.
2. 2.Evaluation of the nasal symmetry.

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Alar base width

  3 months

• Columella length.

  3 months

• Columella angle deviation.

  3 months

• Nostril height and width on the cleft side.

  3 months

• Nostril height and width on the non-cleft side

  3 months

Study Arms (3)

Adhesive nasoalveolar molding (GS-NAM)

ACTIVE COMPARATOR

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

Conventional nasoalveolar molding

EXPERIMENTAL

(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

normal children

NO INTERVENTION

normal children which will be compared with groups 1 and 2 for results evaluation

Interventions

Nasoalveolar molding in unilateral cleft lip and palate DEVICE

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

Also known as: NAM

Adhesive nasoalveolar molding (GS-NAM); Conventional nasoalveolar molding

Eligibility Criteria

• Age: 7 Days - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Faculty of dental medicine

Cairo, 4050113, Egypt

Location

Faculty of Dental Medicine (Boys, Cairo), Al- Azhar University

Cairo, 4450113, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Interventions

Nasoalveolar Molding

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Preoperative Care; Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Adel F Hassan, Phd

  Fucalty of dental medicine

  STUDY DIRECTOR

Central Study Contacts

Ahmed F Ahmed, Master

CONTACT

00201009050985; Ahmedfarghly0@gmail.com

Adel F Hassan, Phd

CONTACT

00201124591323; Adelfathy@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 11, 2024
• Study Start: July 20, 2024
• Primary Completion: July 20, 2025
• Study Completion: August 20, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 4 months
• Access Criteria: all IPD that underlie results in a publication

Locations

EG (2)