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

NCT ID: NCT04225637

Last Updated: 2021-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-06-01

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.

Conditions

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Palatal Expansion Technique Malocclusion Posterior Crossbite Maxillary Hypoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Slow maxillary expansion

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

Group Type EXPERIMENTAL

Miniscrew-Supported Maxillary Expander- Slow activation

Intervention Type 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.

Rapid maxillary expansion

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

Group Type EXPERIMENTAL

Miniscrew-Supported Maxillary Expander- Rapid activation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Yomna Mohamed Mohamed Yacout

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yomna M Yacout, BDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Nadia M El Harouni, BDS,MSc,PhD

Role: STUDY_CHAIR

Alexandria University

Essam M Abdallah, BDS,MSc,PhD

Role: STUDY_CHAIR

Alexandria University

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 25490552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25564504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20197161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28486682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27925236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36890253 (View on PubMed)

Related Links

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https://ohrp.cit.nih.gov/search/IrbDtl.aspx

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

Other Identifiers

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01012019

Identifier Type: -

Identifier Source: org_study_id

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