An interventional study of The bonded McNamara-type appliance and The removable palatal expansion appliance in Constriction, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 12 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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?
1,117 studies on the registry are indexed under Constriction, Pathologic; 229 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 671 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Damascus University is the lead sponsor of 210 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.
Device: The bonded McNamara-type appliance
The slow maxillary expansion will be applied using a removable palatal expansion appliance.
Device: The removable palatal expansion appliance
The patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.
The slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.
Change in the levels of discomfort or pain
The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): 'What is the degree of discomfort/pain?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of discomfort/pain.
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of mastication difficulties
The degree of mastication difficulties that patients feel will be determined using their answers to the following question (question 02): 'What is the degree of mastication difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of mastication difficulties.
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of swallowing difficulties
The degree of swallowing difficulties that patients feel will be determined using their answers to the following question (question 03): ' What is the degree of swallowing difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of swallowing difficulties.
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of sensation of pressure on soft tissue
The degree of any sense of pressure in soft tissue that patients feel will be determined using their answers to the following question (question 04): ' What is the degree of any sense of pressure in soft tissue? ' The Visual Analogue Scale (VAS) will be adopted to measure the degree of any sense of pressure in soft tissue.
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Plan to share: No
Ran from Feb 2020 to primary completion in Mar 2021, 13 months.
Of 201 non-industry interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's 13 months is below that.
Counting every sponsor, half of 287 studies reached it within 36 months; a quarter within 19 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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