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

NCT04225637 | Completed

• 1 other identifier: 01012019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Palatal Expansion Technique; Malocclusion; Posterior Crossbite; Maxillary Hypoplasia

Keywords

Rapid Palatal Expansion; Slow Palatal Expansion; Miniscrew; Bone-borne Expander

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pain score on Numeric Rating Scale (NRS) at baseline

  Baseline

• Pain score on NRS after the first activation of the maxillary expander

  On day 1 after the first activation of the maxillary expander

• Pain score on NRS after 1 week of activation of the maxillary expander

  After 1 week of activation of the maxillary expander

• 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)

Study Arms (2)

Slow maxillary expansion

EXPERIMENTAL

The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.

Device: Miniscrew-Supported Maxillary Expander- Slow activation

Rapid maxillary expansion

EXPERIMENTAL

The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.

Device: Miniscrew-Supported Maxillary Expander- Rapid activation

Interventions

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.

Slow maxillary expansion

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.

Rapid maxillary expansion

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (6)

• 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.

  PMID: 25490552 BACKGROUND

• 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.

  PMID: 25564504 BACKGROUND

• 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.

  PMID: 20197161 BACKGROUND

• 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.

  PMID: 28486682 BACKGROUND

• 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.

  PMID: 27925236 BACKGROUND

• ElNaghy R, Al-Qawasmi R, Hasanin M. Do patient-reported outcomes of miniscrew-supported maxillary expansion in adolescent patients differ between slow and rapid activation protocol? Evid Based Dent. 2023 Mar;24(1):28-29. doi: 10.1038/s41432-023-00858-8. Epub 2023 Mar 8.

  PMID: 36890253 DERIVED

Related Links

• Institutional Review Board (IORG0008839/IRB00010556- Faculty of Dentistry - Alexandria University )

MeSH Terms

Conditions

Malocclusion; Retrognathia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yomna M Yacout, BDS, MSc

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Nadia M El Harouni, BDS,MSc,PhD

  Alexandria University

  STUDY CHAIR

• Essam M Abdallah, BDS,MSc,PhD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 13, 2020
• Study Start: March 1, 2019
• Primary Completion: April 28, 2021
• Study Completion: June 1, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)