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NCT05692817 Clinical Trial

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

Orthodontic Appliance Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05692817
Other study ID # 891/2786
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date July 1, 2025

Study information
Verified date January 2023
Source Al-Azhar University
Contact Ammar Alzoubi
Phone 01200726270
Email ammar.alzoubi91@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 16
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 22 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

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.

Locations
Country Name City State
Egypt Alazhar University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ammar Kasem Alzoubi

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of canine retraction distance four months
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