Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
NCT ID: NCT04734054
Last Updated: 2021-02-02
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
32 participants
INTERVENTIONAL
2018-03-19
2019-09-22
Brief Summary
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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.
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Detailed Description
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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?.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rapid maxillary expansion
The rapid maxillary expansion will be conducted using bonded modified Hyrax palatal expander. The expander will be activated twice daily (0.4 mm) until an overcorrection of 2-3 mm will be gained.
Modified Hyrax Palatal Expander
The rapid maxillary expansion will be performed. The expansion should be accomplished between 10 to 15 days at most. The screw is going to be turned in a rapid manner.
Slow maxillary expansion
The slow maxillary expansion using a removable plate with a midline screw will be accomplished. The expander will be activated twice weekly until an overcorrection of 2-3 mm will be gained.
Removable Palatal Expander
The slow maxillary expansion will be performed. The expansion will be performed in a slow manner. Patients may need between 6 to 8 months to achieve the required expansion.
Interventions
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Modified Hyrax Palatal Expander
The rapid maxillary expansion will be performed. The expansion should be accomplished between 10 to 15 days at most. The screw is going to be turned in a rapid manner.
Removable Palatal Expander
The slow maxillary expansion will be performed. The expansion will be performed in a slow manner. Patients may need between 6 to 8 months to achieve the required expansion.
Eligibility Criteria
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Inclusion Criteria
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
2. Presence of general diseases, syndromes or cleft lip and palate
3. Patients with previous orthodontic treatment
4. Patients with severe horizontal growth pattern
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
Role: PRINCIPAL_INVESTIGATOR
MSc student in Orthodontics, University of Damascus, Dental School, Damascus, Syria
Mohammad Y Hajeer, DDS,MSc,PhD
Role: STUDY_CHAIR
Associate Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria
Locations
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Department of Orthodontics, University of Damascus Dental School
Damascus, , Syria
Countries
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References
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Martina R, Cioffi I, Farella M, Leone P, Manzo P, Matarese G, Portelli M, Nucera R, Cordasco G. Transverse changes determined by rapid and slow maxillary expansion--a low-dose CT-based randomized controlled trial. Orthod Craniofac Res. 2012 Aug;15(3):159-68. doi: 10.1111/j.1601-6343.2012.01543.x. Epub 2012 Mar 27.
Gecgelen M, Aksoy A, Kirdemir P, Doguc DK, Cesur G, Koskan O, Ozorak O. Evaluation of stress and pain during rapid maxillary expansion treatments. J Oral Rehabil. 2012 Oct;39(10):767-75. doi: 10.1111/j.1365-2842.2012.02330.x. Epub 2012 Jul 11.
Cossellu G, Lanteri V, Lione R, Ugolini A, Gaffuri F, Cozza P, Farronato M. Efficacy of ketoprofen lysine salt and paracetamol/acetaminophen to reduce pain during rapid maxillary expansion: A randomized controlled clinical trial. Int J Paediatr Dent. 2019 Jan;29(1):58-65. doi: 10.1111/ipd.12428. Epub 2018 Oct 9.
Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Almallah MM, Almahdi WH, Hajeer MY. Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):ZC23-ZC28. doi: 10.7860/JCDR/2016/22813.8804. Epub 2016 Nov 1.
Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
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.
Baldini A, Nota A, Santariello C, Assi V, Ballanti F, Cozza P. Influence of activation protocol on perceived pain during rapid maxillary expansion. Angle Orthod. 2015 Nov;85(6):1015-20. doi: 10.2319/112114-833.1. Epub 2015 Mar 10.
Bucci R, D'Anto V, Rongo R, Valletta R, Martina R, Michelotti A. Dental and skeletal effects of palatal expansion techniques: a systematic review of the current evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2016 Jul;43(7):543-64. doi: 10.1111/joor.12393. Epub 2016 Mar 23.
Other Identifiers
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UDDS-Ortho-02-2021
Identifier Type: -
Identifier Source: org_study_id
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