Pain, Discomfort, and Functional Impairments During Maxillary Expansion (NCT05248087) | Clinical Trial Compass
CompletedNot Applicable
Pain, Discomfort, and Functional Impairments During Maxillary Expansion
Syria52 participantsStarted 2020-02-20
Plain-language 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.
Who can participate
Age range
12 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the levels of discomfort or pain
Timeframe: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
2
Change in the levels of mastication difficulties
Timeframe: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
3
Change in the levels of swallowing difficulties
Timeframe: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
4
Change in the levels of sensation of pressure on soft tissue
Timeframe: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months