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OpenTrials
Completed

NCT Number: NCT07384338

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapid maxillary expansion

Other

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

Leaf Self Expander

Other

Patients were treated with Leaf Self Expander for maxillary expansion.

Primary outcomes

  1. Measurement of linear skeletal change

    Time frame: 6 months post-expansion

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

Secondary outcomes

  1. Measurement of angular skeletal change

    Time frame: 6 months post-expansion

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

  2. Measurement of linear dental change

    Time frame: 6 months post-expansion

    Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.

  3. Measurement of angular dental change

    Time frame: 6 months post-expansion

    Angular dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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