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Completed

NCT Number: NCT07056296

Efficiency of Two Maxillary Expanders for Maxillary Arch Expansion in Bilateral Cleft Lip and Palate Patients

This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft

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Key information

Conditions

Bilateral Cleft Lip and Palate Maxillary Expansion

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abbaseya, 11566, Egypt

About this study

The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with age ranging from 8 to 15 years old.
  • Patients with bilateral cleft lip and palate.
  • Patients with repaired cleft lip and / or palate.
  • Patients with fully erupted upper permanent 1st molars.
  • Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment.
  • Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4).

Exclusion criteria

  • Patients with syndromic cleft lip and palate.
  • Patients with very bad oral hygiene and active periodontal disease.
  • Vulnerable groups

Treatment and study plan

3D Maxillary Expansion with 3 expansion screws

Device

In patients requiring maxillary expansion, after randomization and allocation for each to receive which expander, appliance will be cemented. In the 3-way group (A), 3 screw activations will be delivered by the care giver to expand the maxillary arch in 3D manner correcting the collapsed arch anteriorly.

Other names: 3-way expander, Group (A)

3D Maxillary Expansion using modified Fan expander with springs

Device

For the fan expander with palatal springs (B) , spring activation will be done by the operator after cemenation intraorally, then the care giver too will just activate one fan screw. Also 3D expansion evaluation was done.

Other names: Fan expander, Group (B)

Primary outcomes

  1. Maxillary arch development in Anteroposterior dimension

    Time frame: [Time Frame: 6 - 12 months]

    Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms

Secondary outcomes

  1. Inter-canine width expansion in the transverse plane

    Time frame: [Time Frame: 6- 12 months]

    Inter-canine width expansion in the transverse plane measured on Digital dental models.

  2. Dental changes with expansion

    Time frame: [Time Frame: 6- 12 months]

    Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficiency of a New Versatile Three-Way Maxillary Expander Versus Modified Fan Expander for Maxillary Arch Expansion in Cleft Lip and Palate Patients: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

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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