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Pain, Discomfort, and Functional Impairments During Maxillary Expansion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05248087
Enrollment
52
Registered
2022-02-21
Start date
2020-02-20
Completion date
2021-07-25
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constriction

Keywords

Pain, Discomfort, Crossbite, Maxillary expansion

Brief summary

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

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?

Interventions

DEVICEThe bonded McNamara-type appliance

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.

DEVICEThe removable palatal expansion appliance

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.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

1. Adolescents between 12 and 16 years. 2. Early permanent dentition. 3. Skeletal bilateral maxillary constriction. 4. There is no loss or absence of any permanent teeth except for the third molar. 5. Dental and skeletal class I/II malocclusion. 6. Normal/mild vertical growth pattern.

Exclusion criteria

1. Previous orthodontic treatment. 2. A severe horizontal growth pattern. 3. Any periodontal diseases. 4. Any general diseases or syndromes.

Design outcomes

Primary

MeasureTime frameDescription
Change in the levels of discomfort or painT1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 monthsThe 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.
Change in the levels of mastication difficultiesT1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 monthsThe 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.
Change in the levels of swallowing difficultiesT1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 monthsThe 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.
Change in the levels of sensation of pressure on soft tissueT1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 monthsThe 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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026