Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient

July 20, 2021 updated by: sarah salah khalil Abdelaal, Faculty of Dental Medicine for Girls

Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cleft lip and palate are among the most common deformities in children.Clefts patient are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty . Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth The upper jaw of patients with cleft palate will be expanded by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .

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

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 0000
        • Recruiting
        • faculty of dental medicine for Girls, Al- Azhar University
        • Contact:

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 ranges from 8 to 12 years.
  • All the cases showed maxillary arch constriction and deficiently
  • All patients had maxillary permanent first molars.
  • Primary lip adhesion and palatal closure.

Exclusion Criteria:

  • Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.

    2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .

    3. Absent maxillary permanent first molars. 4. 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
Clefts patient with transverse maxillary constriction and anteroposterior deficiency
Device: Maxillary Expander with Differential Opening (EDO)
The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
Device: Petit Face Mask

The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion.

consist of forehead cap chin cap cross bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in 3D dimension of skull after and before expansion
Time Frame: six month
Full skull Cone Beam Computerized Tomography
six month

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: maha m. mohamed, phd, Lecturer of Orthodontics Department Faculty of Dental Medicine for Girls Al-Azhar University

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.

General Publications

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)

July 15, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO-109-2-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Evaluation of EDO ,Alt-RAMEC With Facemask in Patients With Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

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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