Comparative Results of Maxillary Deficiency Treatment by... | NCT00916084

Studies
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients

NCT00916084

Sponsor

Shahid Beheshti University

Status

Unknown status

Last Update Posted

Jul 27, 2010Estimated

Enrollment

20Estimated

Phase

Phase 3

Conditions

Maxillary Deficiency

Interventions

Fixed Tongue Appliance
Fixed Face Mask

Countries

Iran

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

Aug 2010Estimated

First Submitted Date

Jun 8, 2009

First Submission Date that Met QC Criteria

Jun 8, 2009

First Posted Date

Jun 9, 2009Estimated

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

Jul 26, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

Detailed Description

The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental		Device: Fixed Tongue Appliance
Group B	Experimental		Device: Fixed Face Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fixed Tongue Appliance	Device	A functional appliance used for maxillary protraction. It has two bands on first molars, expansion screw and long palatal plate in the canine area which cages the tongue and transfers the force of the tongue during physiological activity to the upper arch.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cephalometric angles and clinical features		At least 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Growing patients
Class III with maxillary deficiency

Exclusion Criteria:

Previous orthodontic treatment
Uncooperative patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Behnaz, Orthodontist	Contact	09123278021		behnaz1357@yahoo.com

Overall Officials

Name	Affiliation	Role
Rahman Showkatbakhsh, Professor	Shaheed Beheshti dental school	Study Chair
Mohammad Behnaz	Shahid Beheshti Dental school	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Beheshti Medical University	Recruiting	Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D063173	Retrognathia

Ancestor Terms

ID	Term
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D019767	Maxillofacial Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008397	Masks

Ancestor Terms

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D011482	Protective Devices

Browse Leaves

Not provided

Browse Branches

Not provided