Evaluation of Maxillary Canine Retraction Assisted With Two Different Methods of Low-Intensity Pulsed Ultrasound

January 12, 2023 updated by: Ammar Kasem Alzoubi

Evaluation of Maxillary Canine Retraction Assisted With Two Different Methods of Low-Intensity Pulsed Ultrasound: A Controlled Clinical Study

The current clinical study will be done for evaluation of maxillary canine retraction assisted with application of two different methods of low-intensity pulsed ultrasound.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

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
      • Cairo, Egypt, 99988
        • Recruiting
        • Alazhar University
        • Contact:
          • Ammar Elzoubi
          • Phone Number: 01008420220

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

15 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

All patients should satisfy the following criteria:

  1. An age ranges from 15-22 years.
  2. Severe crowding or protrusion requiring 1st premolar extractions followed by symmetrical canine retraction.
  3. All permanent teeth present, 3rd molars are excluded.
  4. Good oral hygiene.
  5. No systemic disease/medication that could interfere with orthodontic tooth Movement (OTM).
  6. No previous orthodontic treatment.

Exclusion Criteria:

  • 1. Patient diagnosed to have an indication for non-extraction approach. 2. Poor oral hygiene or periodontally compromised patient. 5 3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions. 4. Previous orthodontic treatment. 5. Any implanted assistive devices (e.g., pacemakers, cochlear implants, etc.) 6. Pregnant females.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: one- weeks group
Device: Low-Intensity Pulsed Ultrasound

The total sample will be randomly divided into two equal groups (according to method of application of the lipus on the intervention side)as follows: ■ Group I: will include 8 patients who will receive lipus with maxillary canine retraction that will be performed every (3 weeks) on intervention 6 sides according to a standardized protocol.

▪ Group II: will include 8 patients who will receive lipus that will be performed every (1 week) on intervention sides according to a standardized protocol.
Experimental: three-weeks group
Device: Low-Intensity Pulsed Ultrasound

The total sample will be randomly divided into two equal groups (according to method of application of the lipus on the intervention side)as follows: ■ Group I: will include 8 patients who will receive lipus with maxillary canine retraction that will be performed every (3 weeks) on intervention 6 sides according to a standardized protocol.

▪ Group II: will include 8 patients who will receive lipus that will be performed every (1 week) on intervention sides according to a standardized protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of canine retraction
Time Frame: four months
distance
four months

Collaborators and Investigators

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

Sponsor

Ammar Kasem Alzoubi

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)

January 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 891/2786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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