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

June 18, 2021 updated by: Yomna Mohamed Mohamed Yacout, Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
Time Frame: 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.
On day 1 after the first activation of the maxillary expander
Pain score on NRS after 1 week of activation of the maxillary expander
Time Frame: 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
Time Frame: 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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

April 28, 2021

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

January 5, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01012019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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