Clinical trial NCT04225637: Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents
Official title: Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palatal Expansion Technique
Malocclusion
Posterior Crossbite
Maxillary Hypoplasia
Keywords: Rapid Palatal Expansion
Slow Palatal Expansion
Miniscrew
Bone-borne Expander
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Permanent dentition.
* Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
* Good oral hygiene

Exclusion Criteria:

* History of previous orthodontic or orthopedic treatment
* History of maxillary trauma
* Patients with congenital craniofacial malformations
* Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response

Primary outcomes:
measure: Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
timeFrame: At baseline and an average of 5 months after the initial activation
measure: Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
timeFrame: At baseline and an average of 5 months after the initial activation
Secondary outcomes:
measure: Pain score on Numeric Rating Scale (NRS) at baseline
timeFrame: Baseline
measure: Pain score on NRS after the first activation of the maxillary expander
timeFrame: On day 1 after the first activation of the maxillary expander
measure: Pain score on NRS after 1 week of activation of the maxillary expander
timeFrame: After 1 week of activation of the maxillary expander
measure: Pain score on NRS after the last activation of the maxillary expander
timeFrame: 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)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Yomna M Yacout, BDS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Nadia M El Harouni, BDS,MSc,PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Essam M Abdallah, BDS,MSc,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.