Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements

September 5, 2023 updated by: farouk ahmed hussein, Al-Azhar University

Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation

The aim of this prospective clinical project will be to compare the effect of low-level laser therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth movements

Study Overview

Detailed Description

The aim of this prospective clinical project will be to compare the effect of low-level laser therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth movements, specifically; canine retraction, incisors' leveling and alignment, maxillary molar distalization, and incisors' intrusion

Study Type

Interventional

Enrollment (Estimated)

82

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 Locations

      • Cairo, Egypt
        • Alazhar University

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- A- leveling and alignment Eligibility criteria

1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement

Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third molars not included); Moderate mandibular anterior crowding (with little's irregularity index score greater than 4 mm) who required non-extraction approach in the mandibular arch; No tooth size, shape or root abnormalities visible on the patient's radiographic records; No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of the bracket at the

initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria

Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss

Exclusion Criteria:

- Patients who required surgery to correct skeletal discrepancies. Patients with congenital dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor oral hygiene and/or periodontally compromised patients Severe dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LLLT side canine retraction
translation of maxillary canine that will be performed with LLLT application according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: LLLT side canine retraction control side
LLLT side canine retraction control side wihout intervention
Experimental: LLLT group: distalization intervntion side
distalization will be commenced with application of LLLT according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: LLLT group: distalization control side
distalization will be commenced without application of LLLT according to a standardized protocol
Experimental: LLLT group: leveling and alignment
leveling and alignment be commenced with application of LLLT according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: leveling and alignment without intervention
Experimental: LLLT group: Intrusion
intrusion assisted with application of LLLT according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: intrusion control group
intrusion without intervention
Experimental: Lipus side: canine retraction
application of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: LIPUS side control side
LIPUS side:canine retraction control side
Experimental: LIPUS groupMolar distalization group inrervention side
distalization assisted with LIPUS according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
No Intervention: LIPUS groupMolar distalization group control side
distalization without LIPUS intervention
Experimental: LIPUS group: leveling and alignment
leveling and alignment assisted with LIPUS according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound
Experimental: LIPUS group: Intrusion
intrusion assisted with LIPUS according to a standardized protocol
LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
Other Names:
  • low intensity pulsed ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter
Time Frame: post interventionalal at 6months
rate of orthodontic tooth movement by millimeter
post interventionalal at 6months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 19, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 926/91

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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