NCT05692817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 12, 2023

Last Update Submit

January 12, 2023

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • Rate of canine retraction

    distance

    four months

Study Arms (2)

one- weeks group

EXPERIMENTAL
Device: Low-Intensity Pulsed Ultrasound

three-weeks group

EXPERIMENTAL
Device: Low-Intensity Pulsed Ultrasound

Interventions

Low-Intensity Pulsed UltrasoundDEVICE

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.

one- weeks groupthree-weeks group

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar University

Cairo, 99988, Egypt

RECRUITING

Central Study Contacts

Ammar Alzoubi

CONTACT

01200726270ammar.alzoubi91@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 20, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

EG(1)