Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents
Study Details
Study Description
Brief Summary
Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported expanders. However, there is no consensus in the literature regarding their activation protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow and rapid activation rates of miniscrew-supported expanders on the skeletal changes, dento-alveolar changes and the pain experience.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Transverse maxillary deficiency is one of the problems that are commonly encountered in the orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality for the treatment of transverse maxillary deficiency. However, controversies still exist regarding the activation protocol. One of these controversies is whether using a slow activation protocol would be more beneficial to the patients compared to a rapid activation protocol. Another question that consequently ensues is whether such activation protocol would result in less pain compared to the rapid activation protocol.
The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Slow maxillary expansion The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day. |
Device: Miniscrew-Supported Maxillary Expander- Slow activation
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.
|
| Experimental: Rapid maxillary expansion The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily. |
Device: Miniscrew-Supported Maxillary Expander- Rapid activation
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.
|
Outcome Measures
Primary Outcome Measures
- Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT) [At baseline and an average of 5 months after the initial activation]
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
- Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT [At baseline and an average of 5 months after the initial activation]
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.
Secondary Outcome Measures
- Pain score on Numeric Rating Scale (NRS) at baseline [Baseline]
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
- Pain score on NRS after the first activation of the maxillary expander [On day 1 after the first activation of the maxillary expander]
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
- Pain score on NRS after 1 week of activation of the maxillary expander [After 1 week of activation of the maxillary expander]
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
- Pain score on NRS after the last activation of the maxillary expander [At the end of active expansion (an estimated average of 2 to 3 weeks in the rapid expansion group, and 7 to 12 weeks in the slow expansion group)]
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Permanent dentition.
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Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
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Good oral hygiene
Exclusion Criteria:
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History of previous orthodontic or orthopedic treatment
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History of maxillary trauma
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Patients with congenital craniofacial malformations
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Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
Sponsors and Collaborators
- Alexandria University
Investigators
- Principal Investigator: Yomna M Yacout, BDS, MSc, Alexandria University
- Study Chair: Nadia M El Harouni, BDS,MSc,PhD, Alexandria University
- Study Chair: Essam M Abdallah, BDS,MSc,PhD, Alexandria University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Institutional Review Board (IORG0008839/IRB00010556- Faculty of Dentistry - Alexandria University )
- Faculty of Dentistry, Alexandria University
Publications
- Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod. 2018 Jan 23;40(1):97-106. doi: 10.1093/ejo/cjx035.
- Carvalho Trojan L, Andrés González-Torres L, Claudia Moreira Melo A, Barbosa de Las Casas E. Stresses and Strains Analysis Using Different Palatal Expander Appliances in Upper Jaw and Midpalatal Suture. Artif Organs. 2017 Jun;41(6):E41-E51. doi: 10.1111/aor.12817. Epub 2016 Dec 7.
- Lagravère MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
- Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
- Yılmaz A, Arman-Özçırpıcı A, Erken S, Polat-Özsoy Ö. Comparison of short-term effects of mini-implant-supported maxillary expansion appliance with two conventional expansion protocols. Eur J Orthod. 2015 Oct;37(5):556-64. doi: 10.1093/ejo/cju094. Epub 2015 Jan 6.
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