Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients

NCT07384338 | Completed

• 1 other identifier: P-OR-23-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the dento-alveolar changes after maxillary expansion in cleft lip and palate patients by Leaf Self Expander, as compared to conventional Rapid Maxillary Expander using digital cast analysis and three-dimensional cone-beam computed tomography.

Conditions

Dento-Skeletal; Three Dimensional; Leaf Self Expander; Cleft Lip; Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Measurement of linear skeletal change

  Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.

  6 months post-expansion

Secondary Outcomes (3)

• Measurement of angular skeletal change

  6 months post-expansion

• Measurement of linear dental change

  6 months post-expansion

• Measurement of angular dental change

  6 months post-expansion

Study Arms (2)

Group A (Control group)

ACTIVE COMPARATOR

Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. Patients were treated with Leaf Self Expander for maxillary expansion.

Other: Rapid maxillary expansion

Group B (Tested group)

EXPERIMENTAL

Patients were treated with Leaf Self Expander for maxillary expansion.

Other: Leaf Self Expander

Interventions

Rapid maxillary expansion OTHER

Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.

Group A (Control group)

Leaf Self Expander OTHER

Patients were treated with Leaf Self Expander for maxillary expansion.

Group B (Tested group)

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with unilateral or bilateral cleft lip and palate in mixed dentition.
• Lip and palate repair was performed from 3 to 24 months of age.
• Presence of maxillary constriction and need of maxillary expansion prior to secondary alveolar bone grafting.
• Good periodontal health.

You may not qualify if:

• Previous orthodontic treatments.
• Any systemic diseases.
• Multiple carious lesions.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, Orthodontic Department, Faculty of Oral and Dental Medicine, MUST University.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 3, 2026
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)