Pain, Discomfort, and Functional Impairments During Maxillary Expansion
NCT ID: NCT05248087
Last Updated: 2022-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2020-02-20
2021-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The rapid maxillary expansion
The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.
The bonded McNamara-type 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
The slow maxillary expansion will be applied using a removable palatal expansion appliance.
The removable palatal expansion appliance
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.
Interventions
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The bonded McNamara-type 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 removable palatal expansion appliance
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.
Eligibility Criteria
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Inclusion Criteria
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
2. A severe horizontal growth pattern.
3. Any periodontal diseases.
4. Any general diseases or syndromes.
12 Years
16 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Nancy Rabah, DDS,MSc
Role: PRINCIPAL_INVESTIGATOR
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Heba M Al-Ibrahim, DDS,MSc
Role: PRINCIPAL_INVESTIGATOR
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Mohammad Y Hajeer, DDS,MSc,PhD
Role: STUDY_CHAIR
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Rashad M.T. Murad, DDS,MSc,PhD
Role: STUDY_CHAIR
Professor of Pharmaceutics, University of Damascus, Faculty of Pharmacology, Damascus, Syria.
Locations
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University of Damascus
Damascus, , Syria
Countries
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References
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Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
Halicioglu K, Kiki A, Yavuz I. Subjective symptoms of RME patients treated with three different screw activation protocols: a randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):225-31.
Feldmann I, Bazargani F. Pain and discomfort during the first week of rapid maxillary expansion (RME) using two different RME appliances: A randomized controlled trial. Angle Orthod. 2017 May;87(3):391-396. doi: 10.2319/091216-686.1. Epub 2016 Dec 28.
Ugolini A, Cossellu G, Farronato M, Silvestrini-Biavati A, Lanteri V. A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander. Int J Paediatr Dent. 2020 Jul;30(4):421-428. doi: 10.1111/ipd.12612. Epub 2020 Jan 20.
De Felippe NL, Da Silveira AC, Viana G, Smith B. Influence of palatal expanders on oral comfort, speech, and mastication. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):48-53. doi: 10.1016/j.ajodo.2008.01.023.
Other Identifiers
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UDDS-Ortho-02-2022
Identifier Type: -
Identifier Source: org_study_id
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