Bilateral Cleft Lip and PalateNCT07056296
Efficiency of Two Maxillary Expanders for Maxillary Arch Expansion in Bilateral Cleft Lip and Palate Patients
A study testing 3D Maxillary Expansion with 3 expansion screws and 3D Maxillary Expansion using modified Fan expander with springs in people with Bilateral Cleft Lip and Palate and Maxillary Expansion, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Cleft Lip and Palate, Maxillary Expansion
- What is being tested?
- 3D Maxillary Expansion with 3 expansion screws and 3D Maxillary Expansion using modified Fan expander with springs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2023to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene and active periodontal disease.
- Vulnerable groups
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Orthodontics, Faculty of Dentistry, Ain Shams University
Cairo, Abbaseya, 11566
About this study
Official 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
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
Read the detailed description
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.
- Being tested
- 3D Maxillary Expansion with 3 expansion screws, 3D Maxillary Expansion using modified Fan expander with springs
- Keywords
- Bilateral cleft lip and palate, Expansion, Premaxilla, Three-dimensional expansion, Fan expander, Three- way expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Maxillary Expansion with 3 expansion screwsDevice
Also called 3-way expander, Group (A)
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.
3D Maxillary Expansion using modified Fan expander with springsDevice
Also called Fan expander, Group (B)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 3D Maxillary Expansion using modified Fan expander with springs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary arch development in Anteroposterior dimension
Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms
Measured: [Time Frame: 6 - 12 months]
Secondary outcomes (2)
Inter-canine width expansion in the transverse plane
Inter-canine width expansion in the transverse plane measured on Digital dental models.
Measured: [Time Frame: 6- 12 months]
Dental changes with expansion
Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars
Measured: [Time Frame: 6- 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 May 2023
- Primary completion26 Feb 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056296
- Sponsor's protocol ID
- FDASU-Rec ID 052316
- Status last verified
- May 2023
- First submitted
- 15 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07056296
- Acronym / sponsor ID
- FDASU-Rec ID 052316
- Keywords
- Bilateral cleft lip and palate, Expansion, Premaxilla, Three-dimensional expansion, Fan expander, Three- way expander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Three-way iMini Hyrax group | Experimental | Device: 3D Maxillary Expansion with 3 expansion screwsFor 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. |
| Fan Expander group | Active comparator | Device: 3D Maxillary Expansion using modified Fan expander with springsFor 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene and active periodontal disease.
- Vulnerable groups
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Maxillary Expansion with 3 expansion screwsAlso: 3-way expander, Group (A)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. | Device | Three-way iMini Hyrax group |
| 3D Maxillary Expansion using modified Fan expander with springsAlso: Fan expander, Group (B)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. | Device | Fan Expander group |
Primary outcome
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
2 secondary outcomes
Inter-canine width expansion in the transverse plane
Time frame: [Time Frame: 6- 12 months]
Dental changes with expansion
Time frame: [Time Frame: 6- 12 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Maxillary Expansion with 3 expansion screws and 3D Maxillary Expansion using modified Fan expander with springs in people with Bilateral Cleft Lip and Palate and Maxillary Expansion, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary arch development in Anteroposterior dimension (time frame: [Time Frame: 6 - 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.