CompletedNot Applicable

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

Syria32 participantsStarted 2018-03-19

Plain-language 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.

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

. Patients in the early permanent dentition
. Chronological age between 12 and 16 years
. The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
. Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
. Dental and skeletal class I and II malocclusion
. Normal and mild vertical growth pattern
. The presence of upper first premolars and molars

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

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

Change in the difficulty in mastication

Change in the difficulty in swallowing

Change in the sensation of tension or pressure on soft tissue

Change in the degree of swelling in soft tissues

Trial details

NCT IDNCT04734054

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-15

View on ClinicalTrials.gov More Maxillary Constriction trials

Plain-language summary

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

. Patients in the early permanent dentition
. Chronological age between 12 and 16 years
. The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
. Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
. Dental and skeletal class I and II malocclusion
. Normal and mild vertical growth pattern
. The presence of upper first premolars and molars

What they're measuring

Change in the levels of pain and discomfort

Change in the difficulty in mastication

Change in the difficulty in swallowing

Change in the sensation of tension or pressure on soft tissue

Change in the degree of swelling in soft tissues

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria