Maxillary Expansion in Cleft Lip and Palate PatientsRCTNCT07465939
Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial
A study testing Quadhelix Expander and Minihyrax Expander in people with Maxillary Expansion in Cleft Lip and Palate Patients and Dentoskeletal Effects After Expansion Using Two Different Expanders, run by Cairo University at 1 site in Egypt.
Trial summary
Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Maxillary Expansion in Cleft Lip and Palate Patients, Dentoskeletal Effects After Expansion Using Two Different Expanders
- What is being tested?
- Quadhelix Expander and Minihyrax Expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2025to May 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.
- Unilateral cleft lip and palate
- Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
- Erupted first permanent maxillary molars.
- Good periodontal health.
- No previous orthodontic treatment
Who cannot join
- Syndromic cleft lip and palate patients.
- Previous secondary alveolar bone grafting.
- Taking medications that influence growth.
- Absence of teeth to support the expansion appliance
Trial locations and contacts
1 site in 1 country.
About this study
Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.
To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.
Read the detailed description
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. An important treatment objective in cleft cases is to achieve greater anterior than posterior maxillary expansion since there is a greater anterior than posterior maxillary constriction in most of those patients. Variable appliances have been used for maxillary arch expansion in cleft patients.
- Hyrax expanders exert parallel forces to the alveolar bones and the maxillary complex, generating similar amounts of anterior as well as posterior expansion and might be indicated for patients with overall maxillary transverse deficiency. While with patients of greater anterior constriction, Hyrax expander must be frequently interrupted before the full correction of the anterior transverse deficiency in order to avoid the occurrence of a posterior buccal crossbite.
- Fan-shape expanders and mini-hyrax (supported on the first premolars and associated to a transpalatal arch cemented to the first molars) enhanced expansion in the maxillary anterior region and restricted posterior expansion.
- Mini-hyrax (supported on the first permanent molars) can expand anteriorly as well as posteriorly and was found comparable to hyrax.
I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.
- Conditions
- Maxillary Expansion in Cleft Lip and Palate Patients, Dentoskeletal Effects After Expansion Using Two Different Expanders
- Being tested
- Quadhelix Expander, Minihyrax Expander
- Keywords
- Maxillary Expansion, Cleft, Anterior constriction, Quadhelix, Mini-hyarx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadhelix ExpanderDevice
Maxillary Expander
Minihyrax ExpanderDevice
Maxillary Expander
| Study group | Role | What they receive |
|---|---|---|
| Quadhelix Group | Experimental | CLP pts with quadhelix expander Receives: Device: Quadhelix Expander |
| Minihyrax Group | Active comparator | CLP pts with minihyrax expander Receives: Device: Minihyrax Expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)
Digital models and CBCTs are used to compare dentoskeletal effects before and after expansion
Measured: 6 months
Secondary outcomes (3)
Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)
Digital models \& CBCT
Measured: 6 months
Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)
CBCT
Measured: 6 months
Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)
Molar inclination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start29 May 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Maxillary Expansion in Cleft Lip and Palate PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Complete unilateral cleft lip and palate pts with anterior and/or posterior crossbite at mixed dentition stage prepared for secondary alveolar bone grafting.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465939
- Sponsor's protocol ID
- 27-05-2025
- Acronym
- RCT
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Figueiredo DS, Bartolomeo FU, Romualdo CR, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Dentoskeletal effects of 3 maxillary expanders in patients with clefts: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2014 Jul;146(1):73-81. doi: 10.1016/j.ajodo.2014.04.013.
PubMed 24975001Pugliese F, Palomo JM, Calil LR, de Medeiros Alves A, Lauris JRP, Garib D. Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs. Angle Orthod. 2020 Mar;90(2):233-238. doi: 10.2319/020219-74.1. Epub 2019 Aug 30.
PubMed 31469593Oliveira DD, Bartolomeo FU, Cardinal L, Figueiredo DS, Palomo JM, Andrade I Jr. An alternative clinical approach to achieve greater anterior than posterior maxillary expansion in cleft lip and palate patients. J Craniofac Surg. 2014 Nov;25(6):e523-6. doi: 10.1097/SCS.0000000000001037.
PubMed 25347603Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.
PubMed 27683832IPDTOC Working Group. Prevalence at birth of cleft lip with or without cleft palate: data from the International Perinatal Database of Typical Oral Clefts (IPDTOC). Cleft Palate Craniofac J. 2011 Jan;48(1):66-81. doi: 10.1597/09-217. Epub 2010 Apr 6.
PubMed 20507242Mossey PA, Shaw WC, Munger RG, Murray JC, Murthy J, Little J. Global oral health inequalities: challenges in the prevention and management of orofacial clefts and potential solutions. Adv Dent Res. 2011 May;23(2):247-58. doi: 10.1177/0022034511402083.
PubMed 21490237
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dento-skeletal Effects of Quadhelix Versus Mini-hyrax Expanders in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07465939
- Acronym / sponsor ID
- RCT / 27-05-2025
- Conditions
- Maxillary Expansion in Cleft Lip and Palate Patients, Dentoskeletal Effects After Expansion Using Two Different Expanders
- Keywords
- Maxillary Expansion, Cleft, Anterior constriction, Quadhelix, Mini-hyarx
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Mar 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.
Regarding expansion in cleft lip and palate patients, very few clinical trials were found after searching literature and fewer randomized trials. This means that no enough evidence in literature is tackling expansion in cleft lip and palate patients.
To the best of our knowledge, this study will represent the first RCT to compare the dentoskeletal effects of mini-hyrax vs quadhelix. Since cleft cases usually need greater anterior than posterior expansion, both appliances are capable of anterior expansion. Nevertheless, no other study compared how much anterior expansion could be accomplished by either appliance.
Detailed description
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. An important treatment objective in cleft cases is to achieve greater anterior than posterior maxillary expansion since there is a greater anterior than posterior maxillary constriction in most of those patients. Variable appliances have been used for maxillary arch expansion in cleft patients.
- Hyrax expanders exert parallel forces to the alveolar bones and the maxillary complex, generating similar amounts of anterior as well as posterior expansion and might be indicated for patients with overall maxillary transverse deficiency. While with patients of greater anterior constriction, Hyrax expander must be frequently interrupted before the full correction of the anterior transverse deficiency in order to avoid the occurrence of a posterior buccal crossbite.
- Fan-shape expanders and mini-hyrax (supported on the first premolars and associated to a transpalatal arch cemented to the first molars) enhanced expansion in the maxillary anterior region and restricted posterior expansion.
- Mini-hyrax (supported on the first permanent molars) can expand anteriorly as well as posteriorly and was found comparable to hyrax.
I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Complete unilateral cleft lip and palate pts with anterior and/or posterior crossbite at mixed dentition stage prepared for secondary alveolar bone grafting.
| Arm | Type | Receives |
|---|---|---|
| Quadhelix Group | Experimental | Device: Quadhelix ExpanderCLP pts with quadhelix expander |
| Minihyrax Group | Active comparator | Device: Minihyrax ExpanderCLP pts with minihyrax expander |
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.
- Unilateral cleft lip and palate
- Presence of maxillary constriction that needs maxillary expansion prior to secondary alveolar bone grafting.
- Erupted first permanent maxillary molars.
Key exclusion criteria (4 listed)
- Syndromic cleft lip and palate patients.
- Previous secondary alveolar bone grafting.
- Taking medications that influence growth.
- Absence of teeth to support the expansion appliance
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 |
|---|---|---|
| Quadhelix ExpanderMaxillary Expander | Device | Quadhelix Group |
| Minihyrax ExpanderMaxillary Expander | Device | Minihyrax Group |
Primary outcome
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view)
Time frame: 6 months
Digital models and CBCTs are used to compare dentoskeletal effects before and after expansion
3 secondary outcomes
Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view)
Time frame: 6 months
Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view)
Time frame: 6 months
Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view)
Time frame: 6 months
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 Mar 2026.
- Background: PubMed 24975001Figueiredo DS, Bartolomeo FU, Romualdo CR, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Dentoskeletal effects of 3 maxillary expanders in patients with clefts: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2014 Jul;146(1):73-81. doi: 10.1016/j.ajodo.2014.04.013.
- Background: PubMed 31469593Pugliese F, Palomo JM, Calil LR, de Medeiros Alves A, Lauris JRP, Garib D. Dental arch size and shape after maxillary expansion in bilateral complete cleft palate: A comparison of three expander designs. Angle Orthod. 2020 Mar;90(2):233-238. doi: 10.2319/020219-74.1. Epub 2019 Aug 30.
- Background: PubMed 25347603Oliveira DD, Bartolomeo FU, Cardinal L, Figueiredo DS, Palomo JM, Andrade I Jr. An alternative clinical approach to achieve greater anterior than posterior maxillary expansion in cleft lip and palate patients. J Craniofac Surg. 2014 Nov;25(6):e523-6. doi: 10.1097/SCS.0000000000001037.
- Background: PubMed 27683832Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.
- Background: PubMed 20507242IPDTOC Working Group. Prevalence at birth of cleft lip with or without cleft palate: data from the International Perinatal Database of Typical Oral Clefts (IPDTOC). Cleft Palate Craniofac J. 2011 Jan;48(1):66-81. doi: 10.1597/09-217. Epub 2010 Apr 6.
- Background: PubMed 21490237Mossey PA, Shaw WC, Munger RG, Murray JC, Murthy J, Little J. Global oral health inequalities: challenges in the prevention and management of orofacial clefts and potential solutions. Adv Dent Res. 2011 May;23(2):247-58. doi: 10.1177/0022034511402083.
- Individual participant dataSharing planned: Undecided
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 Quadhelix Expander and Minihyrax Expander in people with Maxillary Expansion in Cleft Lip and Palate Patients and Dentoskeletal Effects After Expansion Using Two Different Expanders, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 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?
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?
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?
Anterior transverse dento-skeletal effects measured by linear distance tool between deciduous upper canines on CBCT and digital models (axial view) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465939, which also lists 6 linked publications.
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 Mar 2026.