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

Not Applicable

Completed

• Conditions: Posterior Crossbite; Malocclusion; Maxillary Hypoplasia; Palatal Expansion Technique
• Interventions: Device: Miniscrew-Supported Maxillary Expander- Slow activation; Device: Miniscrew-Supported Maxillary Expander- Rapid activation

• Registration Number: NCT04225637
• Lead Sponsor: Alexandria University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Primary Completion: 2021-04-28
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow maxillary expansion	Miniscrew-Supported Maxillary Expander- Slow activation	The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.
Rapid maxillary expansion	Miniscrew-Supported Maxillary Expander- Rapid activation	The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt