Pain, Discomfort, and Functional Impairments During Maxillary Expansion

Study Overview
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Brief Summary
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Maxillary expansion is associated with varying degrees of pain and functional impairments. The current study aims to compare rapid maxillary expansion using a McNamara-type (bonded) appliance and slow maxillary expansion using a removable palatal expansion appliance concerning patient-centered outcomes. Those outcomes will include pain and discomfort, mastication difficulties, swallowing difficulties, and pressure on the soft tissues.

Detailed Description
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Skeletal maxillary constriction is one of the common orthodontic problems of all ages, which could be unilateral or bilateral. If it is neglected and not treated, it may result in later orthodontic problems such as skeletal deviation of the lower jaw. The current study aims to use two types of expanders to treat skeletal maxillary constriction in adolescents aged between 12 and 16 years. The study sample will include 52 patients who will be equally divided into two groups: the slow and the rapid maxillary expansion groups. Patients will be asked to answer a questionnaire within five assessment times during the expansion procedure. The questionnaire will contain four questions: 1) What is the degree of discomfort/pain? 2) What is the degree of mastication difficulties? 3) What is the degree of swallowing difficulties? 4) What is the degree of any sense of pressure in soft tissue?

Official Title
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Assessment of Patient-centered Outcomes Associated With the Expansion of Skeletally Constricted Upper Jaw in the Adolescents Using Two Types of Expanders: A Randomized Controlled Trial

Conditions
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Constriction

Intervention / Treatment
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* Device: The bonded McNamara-type appliance
* Device: The removable palatal expansion appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents between 12 and 16 years. Early permanent dentition. Skeletal bilateral maxillary constriction. There is no loss or absence of any permanent teeth except for the third molar. Dental and skeletal class I/II malocclusion. Normal/mild vertical growth pattern. Exclusion Criteria: Previous orthodontic treatment. A severe horizontal growth pattern. Any periodontal diseases. Any general diseases or syndromes.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The rapid maxillary expansion<br>The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance. | Device: The bonded McNamara-type appliance<br>* The patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.<br>|
| Active Comparator: The slow maxillary expansion<br>The slow maxillary expansion will be applied using a removable palatal expansion appliance. | Device: The removable palatal expansion appliance<br>* The slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the levels of discomfort or pain | The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): 'What is the degree of discomfort/pain?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of discomfort/pain. | T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months | 
| Change in the levels of mastication difficulties | The degree of mastication difficulties that patients feel will be determined using their answers to the following question (question 02): 'What is the degree of mastication difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of mastication difficulties. | T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months | 
| Change in the levels of swallowing difficulties | The degree of swallowing difficulties that patients feel will be determined using their answers to the following question (question 03): ' What is the degree of swallowing difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of swallowing difficulties. | T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months | 
| Change in the levels of sensation of pressure on soft tissue | The degree of any sense of pressure in soft tissue that patients feel will be determined using their answers to the following question (question 04): ' What is the degree of any sense of pressure in soft tissue? ' The Visual Analogue Scale (VAS) will be adopted to measure the degree of any sense of pressure in soft tissue. | T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Discomfort, Crossbite, Maxillary expansion