Evaluation Of Different Rapid Orthodontic Expansion Devices

NCT ID: NCT03258411

Last Updated: 2020-04-07

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

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-10

Study Completion Date

2019-04-01

Brief Summary

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Evaluating and comparing the short term effects of different palatal expanders on the amount of palatal expansion and buccal tipping of posterior teeth.

Hypothesis:

H0: There is no difference in the short term effects between the different palatal expanders.

H1: There is a significant difference in the short term effects between the different palatal expanders.

Detailed Description

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Conditions

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Cross Bite

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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Haas group (H)

Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).

Group Type ACTIVE_COMPARATOR

Rapid Expansion of palatal suture

Intervention Type DEVICE

Hyrax (Hx)

Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).

Group Type ACTIVE_COMPARATOR

Rapid Expansion of palatal suture

Intervention Type DEVICE

Miniscrew-supported (MHx)

Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))

Group Type ACTIVE_COMPARATOR

Rapid Expansion of palatal suture

Intervention Type DEVICE

Interventions

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Rapid Expansion of palatal suture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Non-syndromic adolescent patients.
* Patients in need for palatal expansion treatment.
* Average face height.
* No previous orthodontic treatment.

Exclusion Criteria

* Syndromic adolescent patients.
* Patients not in need for palatal expansion treatment.
* Non-average face height.
* Previous orthodontic treatment.
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Najla Alhamdani

Master degree student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.

Reference Type BACKGROUND
PMID: 26432315 (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)

Other Identifiers

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BBRPE

Identifier Type: -

Identifier Source: org_study_id

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