Three DimensionalNCT07384338
Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients
A study testing Rapid maxillary expansion and Leaf Self Expander in people with Three Dimensional and Dento-Skeletal, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Three Dimensional, Dento-Skeletal, Leaf Self Expander
- What is being tested?
- Rapid maxillary expansion and Leaf Self Expander
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 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 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Previous orthodontic treatments.
- Any systemic diseases.
- Multiple carious lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Three Dimensional, Dento-Skeletal, Leaf Self Expander, Cleft Lip, Cleft Palate
- Being tested
- Rapid maxillary expansion, Leaf Self Expander
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid maxillary expansionOther
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Leaf Self ExpanderOther
Patients were treated with Leaf Self Expander for maxillary expansion.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control group) | Active comparator | Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Patients were treated with Leaf Self Expander for maxillary expansion. Receives: Other: Rapid maxillary expansion |
| Group B (Tested group) | Experimental | Patients were treated with Leaf Self Expander for maxillary expansion. Receives: Other: Leaf Self Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of linear skeletal change
Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Measured: 6 months post-expansion
Secondary outcomes (3)
Measurement of angular skeletal change
Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Measured: 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.
Measured: 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.
Measured: 6 months post-expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Sep 2023
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three DimensionalStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Ahmed Almohamady Khalil, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384338
- Sponsor's protocol ID
- P-OR-23-03
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)
- ClinicalTrials.gov ID
- NCT07384338
- Acronym / sponsor ID
- P-OR-23-03
- Conditions
- Three Dimensional, Dento-Skeletal, Leaf Self Expander, Cleft Lip, Cleft Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Feb 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control group) | Active comparator | Other: Rapid maxillary expansionPatients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. Patients were treated with Leaf Self Expander for maxillary expansion. |
| Group B (Tested group) | Experimental | Other: Leaf Self ExpanderPatients were treated with Leaf Self Expander for maxillary expansion. |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous orthodontic treatments.
- Any systemic diseases.
- Multiple carious lesions.
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 |
|---|---|---|
| Rapid maxillary expansionPatients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. | Other | Group A (Control group) |
| Leaf Self ExpanderPatients were treated with Leaf Self Expander for maxillary expansion. | Other | Group B (Tested group) |
Primary outcome
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.
3 secondary outcomes
Measurement of angular skeletal change
Time frame: 6 months post-expansion
Measurement of linear dental change
Time frame: 6 months post-expansion
Measurement of angular dental change
Time frame: 6 months post-expansion
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 3 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Rapid maxillary expansion and Leaf Self Expander in people with Three Dimensional and Dento-Skeletal, run by Al-Azhar 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 4 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 3 Feb 2026. 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?
Measurement of linear skeletal change (time frame: 6 months post-expansion). 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 3 Feb 2026.