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

Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate; Cleft Lip; Three Dimensional; Dento-Skeletal; Leaf Self Expander
• Intervention / Treatment: Other: Rapid maxillary expansion; Other: Leaf Self Expander

Detailed Description

Orofacial clefts are the most prevalent among congenital malformations, which can involve the upper lip, alveolar ridge or/and the palate and, in general, cause esthetic, functional, and psychosocial impairments in different magnitudes, depending on its location and extension.

The Leaf Self Expander (LSE) is a new technology that similar to LE in design except absence of the reactivation screw and respects the principle of producing predetermined light, constant forces, without any intervention by the patient, parents or orthodontist. Where it is composed of three leaf springs compressed by the laboratory before delivery, it is deactivated spontaneously until the programmed expansion is achieved.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Control group); 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; Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Experimental: Group B (Tested group); Patients were treated with Leaf Self Expander for maxillary expansion.	Other: Leaf Self Expander; Patients were treated with Leaf Self Expander for maxillary expansion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of angular skeletal change	Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.	6 months post-expansion
Measurement of linear dental change	Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.	6 months post-expansion
Measurement of angular dental change	Angular dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.	6 months post-expansion

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Lip; Cleft Palate
• Other Study ID Numbers: P-OR-23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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