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

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06020183

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using Four Mini-screws Supported Hyrax in compare with untreated control group.

Condition or Disease	Intervention/Treatment	Phase
Transverse Maxillary Deficiency	Device: Hybrid hyrax	N/A

Detailed Description

Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Methodology:

Essential record for orthodontic treatment will be taken.
impression with bands on upper first molars will be taken.
Four 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.
The appliance will be cemented 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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial

Actual Study Start Date :

Apr 2, 2023

Anticipated Primary Completion Date :

Dec 2, 2023

Anticipated Study Completion Date :

Jun 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid Hyrax these patents will be treated using Four mini-screws supported hyrax	Device: Hybrid hyrax these patents will be treated using Four mini-screws supported hybrid hyrax Other Names: MARPE(miniscrews-assisted rapid palatal expander)
No Intervention: untreated control group Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

Arm

Intervention/Treatment

Experimental: Hybrid Hyrax

these patents will be treated using Four mini-screws supported hyrax

Device: Hybrid hyrax

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

Other Names:

MARPE(miniscrews-assisted rapid palatal expander)

No Intervention: untreated control group

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

Outcome Measures

Primary Outcome Measures

Skeletal maxillary expansion [5 months interval between pre and post-expansion]
To compare the amount of skeletal expansion pre and post expansion

Secondary Outcome Measures

Dento-alaveolar expansion [5 months interval between pre and post-expansion]
To compare the amount of Dento-alaveolar expansion pre and post expansion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Cairo university	Cairo	Giza	Egypt	23646375

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Elzubair Osman, Master Degree student ,Faculty of Dentistry, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

alzubair osman salih, Master Degree student ,Faculty of Dentistry ,Cairo university., Cairo University

ClinicalTrials.gov Identifier:

NCT06020183

Other Study ID Numbers:

14623

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by alzubair osman salih, Master Degree student ,Faculty of Dentistry ,Cairo university., Cairo University

maxillary expasnion

Study Results

No Results Posted as of Aug 31, 2023