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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow maxillary expansion | Experimental | The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day. |
|
| Rapid maxillary expansion | Experimental | The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miniscrew-Supported Maxillary Expander- Slow activation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT) | 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. | At baseline and an average of 5 months after the initial activation |
| Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT | 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. | At baseline and an average of 5 months after the initial activation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score on Numeric Rating Scale (NRS) at 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. | Baseline |
| Pain score on NRS after the first activation of the maxillary expander |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yomna M Yacout, BDS, MSc | Alexandria University | Principal Investigator |
| Nadia M El Harouni, BDS,MSc,PhD | Alexandria University | Study Chair |
| Essam M Abdallah, BDS,MSc,PhD | Alexandria University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25490552 | Background | 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. | |
| 25564504 | Background | Yilmaz A, Arman-Ozcirpici A, Erken S, Polat-Ozsoy O. 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. |
| Label | URL |
|---|---|
| Institutional Review Board (IORG0008839/IRB00010556- Faculty of Dentistry - Alexandria University ) | View source |
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| Miniscrew-Supported Maxillary Expander- Rapid activation | Device | 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. |
|
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. |
| On day 1 after the first activation of the maxillary expander |
| Pain score on NRS 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. | After 1 week of activation of the maxillary expander |
| Pain score on NRS after the last 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. | 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) |
| 20197161 | Background | Lagravere 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. |
| 28486682 | Background | 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. |
| 27925236 | Background | Carvalho Trojan L, Andres Gonzalez-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. |
| 36890253 | Derived | ElNaghy R, Al-Qawasmi R, Hasanin M. Do patient-reported outcomes of miniscrew-supported maxillary expansion in adolescent patients differ between slow and rapid activation protocol? Evid Based Dent. 2023 Mar;24(1):28-29. doi: 10.1038/s41432-023-00858-8. Epub 2023 Mar 8. |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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