Effectiveness of Four Mini-screws Supported Hyrax for Max... | NCT06020183

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

NCT06020183

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 21, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Transverse Maxillary Deficiency

Interventions

Hybrid hyrax

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2023Actual

Primary Completion Date

Jul 2, 2024Estimated

Completion Date

Aug 6, 2024Estimated

First Submitted Date

Aug 25, 2023

First Submission Date that Met QC Criteria

Aug 30, 2023

First Posted Date

Aug 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2024

Last Update Posted Date

Jun 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hybrid Hyrax	Experimental	these patents will be treated using Four mini-screws supported hyrax	Device: Hybrid hyrax
untreated control group	No Intervention	Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hybrid hyrax	Device	these patents will be treated using Four mini-screws supported hybrid hyrax	Hybrid Hyrax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal maxillary expansion	To compare the amount of skeletal expansion pre and post expansion	5 months interval between pre and post-expansion

Secondary Outcomes

Measure	Description	Time Frame
Dento-alaveolar expansion	To compare the amount of Dento-alaveolar expansion pre and post expansion	5 months interval between pre and post-expansion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elzubair Osman	Master Degree student ,Faculty of Dentistry, Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry, Cairo university		Cairo	Giza Governorate	23646375	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided