Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

NCT ID: NCT06130748

Last Updated: 2023-11-14

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-02

Study Completion Date

2024-06-02

Brief Summary

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The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Detailed Description

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Methodology:

* Basic orthodontic record will be taken.
* impression with bands on upper first molars will be taken.
* Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
* CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
* Delivery, check the retention and fitness of the appliance.
* Cementation of the appliance using band cement(compomer).
* Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
* Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
* Closure of the device, and leave the appliance in-situ for five months as a retention.
* Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated

Conditions

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Transverse Maxillary Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Hybrid Hyrax

Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax

Other Names:

• MARPE(miniscrews-assisted rapid palatal expander)

Group Type EXPERIMENTAL

Hybrid Hyrax

Intervention Type DEVICE

these patents will be treated using Two mini-screws supported hybrid hyrax

Untreated control group

Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hybrid Hyrax

these patents will be treated using Two mini-screws supported hybrid hyrax

Intervention Type DEVICE

Other Intervention Names

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MARPE(miniscrews-assisted rapid palatal expander)

Eligibility Criteria

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Inclusion Criteria

* Unilateral or bilateral Dental posterior cross-bite
* Skeletal Maxillary constriction
* Male and female patients.
* Chronological age (18-30 years).
* Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
* Good oral hygiene.
* No craniofacial anomalies or syndromes

Exclusion Criteria

* Scissor-bite
* Orthodontically-treated
* functional cross bite due to premature occlusal contact
* patients with a syndrome
* cleft patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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abdullah mohammed ali al-thalabi

Master Degree student ,Faculty of Dentistry ,Cairo university.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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abdullah mo ali al-thalabi, Msc candidate

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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faculty of dentistry, Cairo university

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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15623

Identifier Type: -

Identifier Source: org_study_id

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