Pain, Discomfort, and Functional Impairments During Maxillary Expansion

Damascus University

Status: Completed

Conditions: Constriction

Treatments: Device: The bonded McNamara-type appliance; Device: The removable palatal expansion appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT05248087

UDDS-Ortho-02-2022

Details and patient eligibility

About

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.

Full 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?

Enrollment: 52 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

52 participants in 2 patient groups

The rapid maxillary expansion

Experimental group

Description:

The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.

Treatment:

Device: The bonded McNamara-type appliance

The slow maxillary expansion

Active Comparator group

Description:

The slow maxillary expansion will be applied using a removable palatal expansion appliance.

Treatment:

Device: The removable palatal expansion appliance