Clinical trial NCT04734054: Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
Official title: Evaluation of Pain, Discomfort, and Functional Impairments During the Orthodontic Treatment of Skeletal Maxillary Constriction Using Rapid Versus Slow Maxillary Expansion in the Early Permeant Dentition: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Constriction
Keywords: posterior crossbite
rapid maxillary expansion
slow maxillary expansion
pain
discomfort
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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?.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the levels of pain and discomfort
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
measure: Change in the difficulty in mastication
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
measure: Change in the difficulty in swallowing
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
measure: Change in the sensation of tension or pressure on soft tissue
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
measure: Change in the degree of swelling in soft tissues
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
measure: Change in patient's perception of treatment ease
timeFrame: T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
name: Nancy Rabah, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: MSc student in Orthodontics, University of Damascus, Dental School, Damascus, Syria
name: Heba M Al-Ibrahim, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_CHAIR
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