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Completed

NCT Number: NCT04225637

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

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.

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Key information

Conditions

Palatal Expansion Technique Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Malocclusion Mandibular Diseases Maxillary Hypoplasia Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Posterior Crossbite Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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