NCT07056296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

June 15, 2025

Last Update Submit

June 29, 2025

Conditions

Bilateral Cleft Lip and PalateMaxillary Expansion

Keywords

Bilateral cleft lip and palateExpansionPremaxillaThree-dimensional expansionFan expanderThree- way expander

Outcome Measures

Primary Outcomes (1)

  • Maxillary arch development in Anteroposterior dimension

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

    [Time Frame: 6 - 12 months]

Secondary Outcomes (2)

  • Inter-canine width expansion in the transverse plane

    [Time Frame: 6- 12 months]

  • Dental changes with expansion

    [Time Frame: 6- 12 months]

Study Arms (2)

Three-way iMini Hyrax group

EXPERIMENTAL

For group (A) cases, a custom-made Three-way palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. Three mini-expansion screws with two break resistant retention legs, oriented as follows: a transverse screw and bilateral sagittal screws.

Device: 3D Maxillary Expansion with 3 expansion screws

Fan Expander group

ACTIVE COMPARATOR

For group (B) cases, a custom-made modified Fan palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. A fan expansion screw with break resistant retention legs with soldered finger springs just palatal to the premaxilla.

Device: 3D Maxillary Expansion using modified Fan expander with springs

Interventions

3D Maxillary Expansion with 3 expansion screwsDEVICE

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.

Also known as: 3-way expander, Group (A)
Three-way iMini Hyrax group
3D Maxillary Expansion using modified Fan expander with springsDEVICE

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.

Also known as: Fan expander, Group (B)
Fan Expander group

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abbaseya, 11566, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 9, 2025

Study Start

May 30, 2023

Primary Completion

February 26, 2025

Study Completion

March 27, 2025

Last Updated

July 9, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)