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

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: Orthodontic Appliance Complication
• Intervention / Treatment: Device: Low-Intensity Pulsed Ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ammar Alzoubi; Phone Number: 01200726270; Email: ammar.alzoubi91@gmail.com

Study Locations

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

Participation Criteria

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:

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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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	distance	four months

Collaborators and Investigators

• Sponsor: Ammar Kasem Alzoubi

Study record dates

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