Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial

Conditions
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Palatal Expansion Technique, Malocclusion, Posterior Crossbite, Maxillary Hypoplasia

Intervention / Treatment
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* Device: Miniscrew-Supported Maxillary Expander- Slow activation
* Device: Miniscrew-Supported Maxillary Expander- Rapid activation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow maxillary expansion<br>The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day. | Device: Miniscrew-Supported Maxillary Expander- Slow activation<br>* 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.<br>|
| Experimental: Rapid maxillary expansion<br>The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily. | Device: Miniscrew-Supported Maxillary Expander- Rapid activation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Palatal Expansion, Slow Palatal Expansion, Miniscrew, Bone-borne Expander