Maxillary DeficiencyPilotNCT06994754
Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage
A study testing clear aligners in people with Maxillary Deficiency and Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Maxillary Deficiency, Cleft Lip and Palate
- What is being tested?
- clear aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mixed dentition.
- Both males and females.
- Bilateral cleft lip and palate.
- Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.
- Presence of maxillary constriction that needs maxillary expansion.
- Good periodontal health.
- No previous orthodontic treatment.
Who cannot join
- Syndromic cleft lip and palate patients.
- Taking medications that influence growth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry - Cairo University
Cairo, Select, 11511
mahmoud abdelsalam, 01112052622, mahmoud.abdelsalam@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study
The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. The main questions it aims to answer are:
Does aligners can achieve transverse dento-skeletal changes? Does aligners can achieve anteroposterior and vertical dento-skeletal changes?
Participants will:
Wear sequence of aligners (each for 10 days). Visit the clinic every month for checkups. 3D x-ray and intraoral scan will be taken after completion of the aligners set to evaluate the intervention.
Read the detailed description
Cleft lip and palate (CLP) is the most prevalent among all craniofacial anomalies, affecting one in every 700 births and disturbing the quality of life of more than 7 million people around the world.
Cleft lip and palate are defined as malformations characterized by the non-union of the upper lip and/or palate, either separately or in conjunction with another syndrome. Its etiology is rather complex and definitely multifactorial, where complex interplay between genetic and environmental factors play a significant role in the incidence and cause of cleft.
Cleft lips can be unilateral or bilateral, and may involve the alveolus or palate. Unilateral cleft lip shows a 2:1 left predominance.
Lip and palate surgical repairs are performed in the first months and years of life respectively. As a consequence, the growth and development of the maxillary segments are compromised by scar tissues, presenting a significant maxillary transverse deficiency with medially collapsed cleft segments accompanied with anterior crossbite or both anterior and posterior crossbites. Most CLP patients present a narrower anterior than posterior maxillary arch frequently showing a crossbite in both canine and premolar areas and a normal occlusal transverse molar relationship.
Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites.
Variable appliances have been used for maxillary arch expansion in cleft patients for example Quad-helix, Hyrax and Haas expanders with its modifications with or without teeth alignment.
The investigators will conducted this clinical trial to evaluate if clear aligners (the new substitute to the conventional metal orthodontics) can achieve true dentoskeletal expansion in the three dimensions.
After clinical examination, intraoral scan taken also intra-oral and extra-oral photos. Requesting full skull CBCT.
Segmentation of teeth and palate using 3-shape software. Using aligner module to plan around 8-12 aligners with maximum velocity of 0.3 mm translation and 3 degree of rotation.
Exporting the models and fabrication of aligners using 1 mm thickness sheets. Delivery of aligners to the patient. Follow up every month. Full face CBCT and intraoral scan will be taken after completion of the intervention.
Measuring and superimpose the data before and after to extract the results.
- Conditions
- Maxillary Deficiency, Cleft Lip and Palate
- Being tested
- clear aligners
- Keywords
- Maxillary Expansion by Aligners
- Medical subject headings
- Retrognathia, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear alignersDevice
aligners made with 1mm thickness sheet and covering the whole palate
| Study group | Role | What they receive |
|---|---|---|
| Bilateral cleft lip and palate patients | Experimental | Not described Receives: Device: clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transverse dento-skeletal changes
Using pre and post treatment cone beam computed tomography (CBCT), 3D point identification and landmark development will be done. On the CBCT, skeletal transvers maxillary width, anterior, middle and posterior cleft width, intermolar, inter premolar and inter-canine widths will be measured.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start6 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmoud abdelsalam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994754
- Sponsor's protocol ID
- ORTH 3-3-7
- Acronym
- Pilot
- Status last verified
- May 2025
- First submitted
- 29 Mar 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study
- ClinicalTrials.gov ID
- NCT06994754
- Acronym / sponsor ID
- Pilot / ORTH 3-3-7
- Conditions
- Maxillary Deficiency, Cleft Lip and Palate
- Keywords
- Maxillary Expansion by Aligners
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 May 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.
The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. The main questions it aims to answer are:
Does aligners can achieve transverse dento-skeletal changes? Does aligners can achieve anteroposterior and vertical dento-skeletal changes?
Participants will:
Wear sequence of aligners (each for 10 days). Visit the clinic every month for checkups. 3D x-ray and intraoral scan will be taken after completion of the aligners set to evaluate the intervention.
Detailed description
Cleft lip and palate (CLP) is the most prevalent among all craniofacial anomalies, affecting one in every 700 births and disturbing the quality of life of more than 7 million people around the world.
Cleft lip and palate are defined as malformations characterized by the non-union of the upper lip and/or palate, either separately or in conjunction with another syndrome. Its etiology is rather complex and definitely multifactorial, where complex interplay between genetic and environmental factors play a significant role in the incidence and cause of cleft.
Cleft lips can be unilateral or bilateral, and may involve the alveolus or palate. Unilateral cleft lip shows a 2:1 left predominance.
Lip and palate surgical repairs are performed in the first months and years of life respectively. As a consequence, the growth and development of the maxillary segments are compromised by scar tissues, presenting a significant maxillary transverse deficiency with medially collapsed cleft segments accompanied with anterior crossbite or both anterior and posterior crossbites. Most CLP patients present a narrower anterior than posterior maxillary arch frequently showing a crossbite in both canine and premolar areas and a normal occlusal transverse molar relationship.
Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites.
Variable appliances have been used for maxillary arch expansion in cleft patients for example Quad-helix, Hyrax and Haas expanders with its modifications with or without teeth alignment.
The investigators will conducted this clinical trial to evaluate if clear aligners (the new substitute to the conventional metal orthodontics) can achieve true dentoskeletal expansion in the three dimensions.
After clinical examination, intraoral scan taken also intra-oral and extra-oral photos. Requesting full skull CBCT.
Segmentation of teeth and palate using 3-shape software. Using aligner module to plan around 8-12 aligners with maximum velocity of 0.3 mm translation and 3 degree of rotation.
Exporting the models and fabrication of aligners using 1 mm thickness sheets. Delivery of aligners to the patient. Follow up every month. Full face CBCT and intraoral scan will be taken after completion of the intervention.
Measuring and superimpose the data before and after to extract the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral cleft lip and palate patients | Experimental | Device: clear aligners |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Mixed dentition.
- Both males and females.
- Bilateral cleft lip and palate.
- Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.
- Presence of maxillary constriction that needs maxillary expansion.
Key exclusion criteria (2 listed)
- Syndromic cleft lip and palate patients.
- Taking medications that influence growth.
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 |
|---|---|---|
| clear alignersaligners made with 1mm thickness sheet and covering the whole palate | Device | Bilateral cleft lip and palate patients |
Primary outcome
Transverse dento-skeletal changes
Time frame: six months
Using pre and post treatment cone beam computed tomography (CBCT), 3D point identification and landmark development will be done. On the CBCT, skeletal transvers maxillary width, anterior, middle and posterior cleft width, intermolar, inter premolar and inter-canine widths will be measured.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
Related trials for Maxillary Deficiency
Active, not recruitingObservational study
Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Implant Placement in Maxillary Esthetic Zone
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clear aligners in people with Maxillary Deficiency and Cleft Lip and Palate, run by Cairo 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mahmoud Abo-Salem, M.SC (+201112052622, mahmoud.abdelsalam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transverse dento-skeletal changes (time frame: six 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 12 Jun 2025.