Effectiveness of Two Maxillary Expanders in Improving the... | NCT04331977

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

NCT04331977

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Cleft Lip and Palate
Maxillary Expansion

Interventions

Maxillary Expansion

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 2023

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

Jul 2, 2020Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Mar 30, 2020

First Submission Date that Met QC Criteria

Apr 1, 2020

First Posted Date

Apr 2, 2020Actual

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 11, 2023

Last Update Posted Date

Feb 14, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

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
Quadhelix Group	Experimental		Device: Maxillary Expansion
Hyrax Group	Active Comparator		Device: Maxillary Expansion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Maxillary Expansion	Device	2 appliances to expand the maxillary arch	Hyrax Group Quadhelix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maxillary Expansion	Amount of Maxillary Expansion to be measured as distances (mm) on CBCTs and dental models.	6 months
Maxillary Expansion	mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Cairo	Giza Governorate	00202	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

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010155	Palatal Expansion Technique

Ancestor Terms

ID	Term
D009971	Orthodontics, Corrective
D009970	Orthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided