Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion

Damascus University

Status: Completed

Conditions: Maxillary Constriction

Treatments: Device: Removable Palatal Expander; Device: Modified Hyrax Palatal Expander

Study type: Interventional

Funder types: Other

Identifiers

NCT04734054

UDDS-Ortho-02-2021

Details and patient eligibility

About

This study will assess and compare the levels of pain, discomfort, and functional impairments between rapid and slow maxillary expansion in treating skeletal maxillary constriction in the early adolescence period (i.e. between 12 and 16 years).

The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. The sample will be allocated randomly into two groups: RME group and SME group.

The patients will be asked to fill out the attached questionnaires at three assessment times.

Full description

Skeletal maxillary constriction is a popular orthodontic malocclusion that can be seen at any age. The maxillary expansion is the most important treatment choice of this skeletal problem in the upper jaw. There are many types of maxillary expansion regarding the force amount and the number of expansion times: slow maxillary expansion (SME) rapid maxillary expansion (RME), and semi-rapid maxillary expansion (SRME).

Practitioners are conscious that complaints submitted by children and adolescents during the active phase of expansion, such as pain, discomfort and oral ulcers are common symptoms. This trial of two parallel groups will compare the pain, discomfort and functional impairments accompanying the rapid and slow maxillary expansion in early adolescent patients.

RME group: A bonded modified Hyrax palatal expander will be applied. SME group: A removable palatal expansion appliance with a midline screw will be applied.

To assess the pain, discomfort and functional impairments, patients will be asked to fill out questionnaires of six questions: 1) What is the degree of pain/discomfort you have experienced?; 2) Do you have difficulty in mastication?; 3) Do you have difficulty in swallowing?; 4) Do you have a sense of tension or pressure in soft tissue?; 5) Do you have swelling in soft tissue?; and 6) How easy is the treatment procedure?.

Enrollment: 32 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients in the early permanent dentition
2. Chronological age between 12 and 16 years
3. The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
4. Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
5. Dental and skeletal class I and II malocclusion
6. Normal and mild vertical growth pattern
7. The presence of upper first premolars and molars
8. No general problems
9. Good oral health
10. No previous orthodontic treatment.

Exclusion criteria

1. Presence of periodontal diseases
2. Presence of general diseases, syndromes or cleft lip and palate
3. Patients with previous orthodontic treatment
4. Patients with severe horizontal growth pattern

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Rapid maxillary expansion

Experimental group

Description:

The rapid maxillary expansion will be conducted using bonded modified Hyrax palatal expander. The expander will be activated twice daily (0.4 mm) until an overcorrection of 2-3 mm will be gained.

Treatment:

Device: Modified Hyrax Palatal Expander

Slow maxillary expansion

Active Comparator group

Description:

The slow maxillary expansion using a removable plate with a midline screw will be accomplished. The expander will be activated twice weekly until an overcorrection of 2-3 mm will be gained.

Treatment:

Device: Removable Palatal Expander