Comparison Between Aesthetic Functional Appliances and Tw... | NCT06631235

Studies
Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II

NCT06631235

Sponsor

Mansoura University

Status

Not yet recruiting

Last Update Posted

Oct 21, 2024Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Skeletal Malocclusion

Interventions

orthopedic appliance
aesthetic orthopedic appliance

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Estimated

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Sep 16, 2024

First Submission Date that Met QC Criteria

Oct 6, 2024

First Posted Date

Oct 8, 2024Actual

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

Oct 18, 2024

Last Update Posted Date

Oct 21, 2024Actual

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

The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)

Detailed Description

The sample will be randomly divided into 2 equal groups according to the appliance will be used:

Group 1: Aesthetic Functional appliance Group 2: Twin block

Methods:

*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.

appliances.

Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.
CBCT will be used to evaluate root resorption and bony changes in the condyle .

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

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
twin block group	Other	patient treated with twin block appliance	Other: orthopedic appliance
aesthetic functional group	Experimental	patient treated with aesthetic functional appliance	Other: aesthetic orthopedic appliance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
orthopedic appliance	Other	appliances are used to correct skeletal class II due to mandibular deficiency	twin block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
skeletal effects	cephalometric linear and angular measurements	one year
dental effects	cephalometric linear and angular measurements	one year
soft tissue effects	cephalometric linear and angular measurements	one year

Secondary Outcomes

Measure	Description	Time Frame
root resorption	root resorption measured from CBCT	one year

Other Outcomes

Measure	Description	Time Frame
CBCT evaluation of TMJ	adverse effects of aesthetic functional appliance on the condylar head	one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
Mandibular deficiency (SNB angle less than 77°).
Growing patients.
No prior orthodontic intervention.
The vertical skeletal classification shows a horizontal or neutral growth pattern.
Overjet ≥ 8mm.

Exclusion Criteria:

Developmental abnormalities with atypical or irregular patterns of growth and maturation.
Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rana ka Abuzaid, orthodontist	Contact	1009389116		ranaabuzaid52@gmail.com
khaled Ah Awad, surgon	Contact	1009297331		khaled_awd2013@yahoo.com

Overall Officials

Name	Affiliation	Role
rana ka Abuzaid, orthodontist	Egyption orthodontic socity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Al Mansurah	Dakahlia Governorate	35516	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

skeletal and dental results

Types

Clinical Study Report (CSR)

Time Frame

2 years

Access Criteria

mandibular advancement

URL

Not provided