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

NCT ID: NCT05692817

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-01

Brief 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.

Conditions

Orthodontic Appliance Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

one- weeks group

Group Type: EXPERIMENTAL

Low-Intensity Pulsed Ultrasound

Intervention Type: DEVICE

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.

three-weeks group

Group Type: EXPERIMENTAL

Low-Intensity Pulsed Ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ammar Kasem Alzoubi

OTHER

Sponsor Role: lead

Responsible Party

Ammar Kasem Alzoubi

Dentist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alazhar University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ammar Alzoubi

Role: CONTACT

ammar.alzoubi91@gmail.com

01200726270

Facility Contacts

Ammar Elzoubi

Role: primary

01008420220

Other Identifiers

891/2786

Identifier Type: -

Identifier Source: org_study_id