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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.
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.
I this study we are comparing the dentoskeletal effects of quadhelix versus mini-hyrax utilizing CBCT and digital models performed before and after expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadhelix Group | Experimental | CLP pts with quadhelix expander |
|
| Minihyrax Group | Active Comparator | CLP pts with minihyrax expander |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadhelix Expander | Device | Maxillary Expander |
| |
| Minihyrax Expander |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary and mandibular anteroposterior measurements measured by linear distance tool and angle measurement tool on CBCT and digital models (sagittal view) | Digital models & CBCT | 6 months |
| Vertical skeletal measurements measured by angle measurement tool (y-axis angle - SnMp) on CBCT (sagittal view) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry Cairo university | Giza | Manial | 11553 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24975001 | Background | 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. | |
| 31469593 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | May 27, 2025 |
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Complete unilateral cleft lip and palate pts with anterior and/or posterior crossbite at mixed dentition stage prepared for secondary alveolar bone grafting.
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| Device |
Maxillary Expander |
|
CBCT |
| 6 months |
| Dentoskeletal Effects measured by angle measurement tool on CBCT (Coronal view) | Molar inclination | 6 months |
| Pugliese 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. |
| 25347603 | Background | Oliveira 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. |
| 27683832 | Background | Figueiredo 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. |
| 20507242 | Background | IPDTOC 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. |
| 21490237 | Background | Mossey 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. |
| Feb 28, 2026 |
| Prot_000.pdf |