Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

August 11, 2021 updated by: Taghreed riyadh saleh alazzawi, Faculty of Dental Medicine for Girls

Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT

maxillary expansion in cleft palate patient with expander and using face mask.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible.

rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening).

with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ● Patients of both sexes.

    • Cleft lip and palate patients.
    • All patient age range 8-12 years.
    • All the case showed maxillary arch constriction and deficiency.
    • All patients had maxillary permanent first molars.
    • Primary lip adhesion and palatal closure.

Exclusion Criteria:

  • • Absent maxillary permanent first molars.

    • Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before.
    • Less than two dental unit beside maxillary first molar.
    • Uncooperative patients/parents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cleft Lip and Palate Patient
Cleft patient with transverse maxillary constriction and anteroposterior deficiency
Device: expander with deferential opening and petit face mask
bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in 3 dimensions of skull before and after expansion
Time Frame: Six months
Full skull Cone Beam Computerized Tomography
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Director: dr. mohsena ahmad, phd, Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO-109-2-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

treatment cleft lip and palate patient with EDO with rapid protocol and face mask

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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