Six Months Follow-up of Two and Four Mini Screws Supporte... | NCT06851624

Studies
Six Months Follow-up of Two and Four Mini Screws Supported Hyrax in Adults

NCT06851624

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Transverse Maxillary Deficiency

Interventions

MARPE

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2023Actual

Primary Completion Date

Dec 5, 2024Actual

Completion Date

Jan 5, 2025Actual

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Feb 27, 2025

First Posted Date

Feb 28, 2025Actual

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

Feb 27, 2025

Last Update Posted Date

Feb 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

abdullah mohammed ali al-thalabi, MSc candidate, Cairo university, department of Orthodontics, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

six months follow-up of two and four mini-screw supported hyrax for maxillary expansion in non-growing patients: A randomized controlled clinical trial

Detailed Description

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group one	Experimental	two mini screws supported hyrax was used	Device: MARPE
Group two	Experimental	four minis crews supported hyrax was used	Device: MARPE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MARPE	Device	treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax	Group one Group two

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal effects	To compare the amount of skeletal expansion using linear (mm) measurement extracted from cone beam computed tomography pre and post-expansion	6-8 months

Secondary Outcomes

Measure	Description	Time Frame
Dento-alveolar effects	To compare the amount of dento-alveolar expansion using linear (mm) measurement extracted from cone beam computed tomography pre and post-expansion	6-8 months
Dento-alveolar effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults male or female aged from 18-30 years with skeletal Maxillary constriction.
unilateral or bilateral Dental posterior cross-bite.
mid-palatal suture maturation (Grade C, D) according to F Angileri classification.
good oral hygiene,

Exclusion Criteria:

no functional crossbite due to premature contacts.
no previous orthodontic treatment.
no buccal crossbite.
no craniofacial anomalies or syndromes

Accepts Healthy Volunteers

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
fady hussein fahim, PhD	Associate proff	Study Director
nada omar elzawahry, PhD	lecturer	Study Director
elzubair osman salih, MSc	MSc candidates	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided