Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486324
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Effects of Asymmetric Rapid Maxillary Expansion on Dentoskeletal Structures in Mixed Dentition
Sponsor:
Celal Irgin
Organization:
TC Erciyes University
Study Overview
Official Title:
Investigation of the Effects of Rapid Maxillary Expansion With Locked Modified Acrylic Bonded Appliance on Dentofacial Structures in Mixed Dentition
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARME
Brief Summary:
The aim of this clinical trial was to determine the efficacy of a locked modified bonded acrylic rapid maxillary expansion appliance also known as an asymmetric rapid maxillary expansion appliance ARME in patients with a true unilateral posterior crossbite resulting from transversal maxillary deficiency in the mixed dentition
Detailed Description:
A posterior crossbite PCB is defined as an abnormal transverse or inverse relationship between the posterior teeth and dentition of the upper and lower jaws A full buccal segment PCB involves multiple teeth in the posterior dentition and usually represents a transverse size discrepancy between the maxillary and mandibular relationships This discrepancy is often caused by narrow or underdeveloped transverse dimensions of the maxillary halves The underlying etiology of PCBs includes congenital developmental traumatic or iatrogenic causes Since spontaneous correction of this malocclusion is not possible even if the etiological factors are eliminated it should be treated with maxillary expansion as early as possible
The PCBs may be seen a unilateral posterior crossbite UPCB or bilateral posterior crossbite during all periods of dentition A UPCB can be described as a functional UPCB or true UPCB A functional UPCB is usually associated with a lateral shift of the mandible toward the crossbite side during the transition of the mandible On the other hand true UPCB is less common than functional UPCB and is caused by the narrowing of one of the maxillary halves Increasing the maxillary arch transverse dimension is the main goal in the treatment of PCB Although bilateral maxillary expansion is usually used to symmetrically widen the maxillary arch and eliminate mandibular shift as a standard treatment model in functional PCB asymmetrical or unilateral maxillary expansion is recommended to expand narrowed sections of the maxillary halves and prevent overexpansion of the non-crossbite side in the treatment of true UPCB Therefore several removable or fixed maxillary expansion appliances that are slowly or rapidly activated were modified to produce differential effects on posterior teeth
This clinical trial was designed to expand the upper jaw asymmetrically ie to prevent the normal side of the bite from expanding while expanding the narrow part of the upper jaw For this purpose a locking mechanism was added to a bonded rapid maxillary expansion RME appliance to support the lower posterior teeth on the normal side of the biteThe hypothesis tested in the study was whether the true unilateral posterior cross-bite in the mixed dentition period could be corrected with a locked modified bonded rapid maxillary expansion appliance used for asymmetric expansion
Children aged between 7 and 10 years old with true unilateral posterior crossbite were enrolled in the study The efficacy of the appliance was compared between the crossbite and non-crossbite sides in the patients included in the study The crossbite side of the patients was assigned as the treatment group while the normal bite or noncrossbite side was assigned as the positive control group Thus two groups were formed for the study and the trial was conducted on these groupsIn other words the study was planned as a self-controlled study A negative control group could not be formed due to ethical reason The reason for this is that the transversal problem may negatively affect both the anterioposterior and vertical development of the jaws in patients of this age during the developmental period and therefore it was deemed necessary to correct the cross-bite problem as soon as possible after it was detectedTherefore the purpose of this study was to evaluate specific dentoskeletal changes induced by treatment with true UPCB in mixed dentition with asymmetric RME
The PCBs may be seen a unilateral posterior crossbite UPCB or bilateral posterior crossbite during all periods of dentition A UPCB can be described as a functional UPCB or true UPCB A functional UPCB is usually associated with a lateral shift of the mandible toward the crossbite side during the transition of the mandible On the other hand true UPCB is less common than functional UPCB and is caused by the narrowing of one of the maxillary halves Increasing the maxillary arch transverse dimension is the main goal in the treatment of PCB Although bilateral maxillary expansion is usually used to symmetrically widen the maxillary arch and eliminate mandibular shift as a standard treatment model in functional PCB asymmetrical or unilateral maxillary expansion is recommended to expand narrowed sections of the maxillary halves and prevent overexpansion of the non-crossbite side in the treatment of true UPCB Therefore several removable or fixed maxillary expansion appliances that are slowly or rapidly activated were modified to produce differential effects on posterior teeth
This clinical trial was designed to expand the upper jaw asymmetrically ie to prevent the normal side of the bite from expanding while expanding the narrow part of the upper jaw For this purpose a locking mechanism was added to a bonded rapid maxillary expansion RME appliance to support the lower posterior teeth on the normal side of the biteThe hypothesis tested in the study was whether the true unilateral posterior cross-bite in the mixed dentition period could be corrected with a locked modified bonded rapid maxillary expansion appliance used for asymmetric expansion
Children aged between 7 and 10 years old with true unilateral posterior crossbite were enrolled in the study The efficacy of the appliance was compared between the crossbite and non-crossbite sides in the patients included in the study The crossbite side of the patients was assigned as the treatment group while the normal bite or noncrossbite side was assigned as the positive control group Thus two groups were formed for the study and the trial was conducted on these groupsIn other words the study was planned as a self-controlled study A negative control group could not be formed due to ethical reason The reason for this is that the transversal problem may negatively affect both the anterioposterior and vertical development of the jaws in patients of this age during the developmental period and therefore it was deemed necessary to correct the cross-bite problem as soon as possible after it was detectedTherefore the purpose of this study was to evaluate specific dentoskeletal changes induced by treatment with true UPCB in mixed dentition with asymmetric RME
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None