Effects of Asymmetric Rapid Maxillary Expansion on Dentoskeletal Structures in Mixed Dentition

NCT ID: NCT06486324

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-01-31

Brief Summary

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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

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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, i.e. 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 bite.The 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 groups.In 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 detected.Therefore, the purpose of this study was to evaluate specific dentoskeletal changes induced by treatment with true UPCB in mixed dentition with asymmetric RME.

Conditions

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Maxillary Anomaly Asymmetric Maxillary Arch (Disorder) Cross Bite

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Split-mouth model. The crossbite side of the patients was assigned as the treatment group, while the normal bite or non-crossbite side of the same patients was assigned as the positive control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment Group

Crossbite Side

Group Type EXPERIMENTAL

A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

Intervention Type DEVICE

asymmetric maxillary expansion

Positive Control Group

Non-cossbite Side

Group Type EXPERIMENTAL

A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

Intervention Type DEVICE

asymmetric maxillary expansion

Interventions

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A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

asymmetric maxillary expansion

Intervention Type DEVICE

A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

asymmetric maxillary expansion

Intervention Type DEVICE

Other Intervention Names

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Narrow maxillary half intended for expansion or crossbite side Normal maxillary half or non-crossbite side

Eligibility Criteria

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Inclusion Criteria

* mixed dentition
* true unilateral posterior crossbite
* erupted first permanent molars and incisors
* all deciduous canines and molars or no more than one missing deciduous molar
* no history of orthodontic treatment
* no systemic disease
* no pathological periodontal status
* no excessive gagging reflex.

Exclusion Criteria

* poor oral hygiene
* caries
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University Scientific Research Projects Unit

UNKNOWN

Sponsor Role collaborator

Celal Irgin

OTHER

Sponsor Role lead

Responsible Party

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Celal Irgin

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Celal Irgın, Asst.Prof.

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

References

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Sari Z, Uysal T, Usumez S, Basciftci FA. Rapid maxillary expansion. Is it better in the mixed or in the permanent dentition? Angle Orthod. 2003 Dec;73(6):654-61. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

Reference Type RESULT
PMID: 14719729 (View on PubMed)

Toroglu MS, Uzel E, Kayalioglu M, Uzel I. Asymmetric maxillary expansion (AMEX) appliance for treatment of true unilateral posterior crossbite. Am J Orthod Dentofacial Orthop. 2002 Aug;122(2):164-73. doi: 10.1067/mod.2002.125563.

Reference Type RESULT
PMID: 12165770 (View on PubMed)

da Silva Filho OG, Boas MC, Capelozza Filho L. Rapid maxillary expansion in the primary and mixed dentitions: a cephalometric evaluation. Am J Orthod Dentofacial Orthop. 1991 Aug;100(2):171-9. doi: 10.1016/s0889-5406(05)81524-0.

Reference Type RESULT
PMID: 1867168 (View on PubMed)

Other Identifiers

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08102026

Identifier Type: -

Identifier Source: org_study_id

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