Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite

August 28, 2023 updated by: Asmaa Salah, Mansoura University
the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

the study *include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.

Study Type

Interventional

Enrollment (Estimated)

24

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 Locations

  • Egypt
      • El Mansura, Egypt, 35511
        • Recruiting
        • Faculty of Dentistry
        • 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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal range i.e. (The crossbite will be diagnosed as functional or dental)

-

Exclusion Criteria:

  1. Systemic conditions that may interfere with the treatment.
  2. Bad habits that might jeopardize the appliance.
  3. Transverse discrepancy.
  4. Previous orthodontic treatment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inclined plane
group treated with inclined plane
Other: inclined plane
2 parallel groups one treated with clear aligner and other treated using inclined plane
Experimental: clear aligner
group treated with clear aligner
Other: clear aligner
2 parallel groups one treated with clear aligner and other treated using inclined plane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(OHRQoL (Oral Health-related Quality of Life)
Time Frame: 4 month
CPQ8-10 scores at two different points in time.
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cephalometric analysis of data
Time Frame: 4 month
compare cephalometric variables between two groups
4 month
3D model measurements
Time Frame: 4 month
compare 3D model measurements variable between 2 group
4 month

Collaborators and Investigators

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

Sponsor

Mansoura University

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 22, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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