Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate

NCT ID: NCT04331977

Last Updated: 2023-02-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2022-12-30

Brief Summary

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This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

Detailed Description

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Conditions

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Cleft Lip and Palate Maxillary Expansion

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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Quadhelix Group

Group Type EXPERIMENTAL

Maxillary Expansion

Intervention Type DEVICE

2 appliances to expand the maxillary arch

Hyrax Group

Group Type ACTIVE_COMPARATOR

Maxillary Expansion

Intervention Type DEVICE

2 appliances to expand the maxillary arch

Interventions

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Maxillary Expansion

2 appliances to expand the maxillary arch

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mixed dentition stage;
* Both males and females;
* Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
* Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
* Permanent first maxillary molars present;
* Good periodontal health;
* No previous orthodontic treatment; and

Exclusion Criteria

* Presence of a syndrome in companion with the present cleft defect.
* Previous secondary alveolar bone grafting.
* Taking medications affecting growth.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 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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Mohamed Abd El-Ghafour

Lecturer of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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121

Identifier Type: -

Identifier Source: org_study_id

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