NCT06026930

Brief Summary

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

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
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

August 19, 2023

Last Update Submit

September 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter

    rate of orthodontic tooth movement by millimeter

    post interventionalal at 6months

Study Arms (14)

Lipus side: canine retraction

EXPERIMENTAL

application of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol

Device: low-level laser therapy

LIPUS side control side

NO INTERVENTION

LIPUS side:canine retraction control side

LLLT side canine retraction

EXPERIMENTAL

translation of maxillary canine that will be performed with LLLT application according to a standardized protocol

Device: low-level laser therapy

LLLT side canine retraction control side

NO INTERVENTION

LLLT side canine retraction control side wihout intervention

LIPUS groupMolar distalization group inrervention side

EXPERIMENTAL

distalization assisted with LIPUS according to a standardized protocol

Device: low-level laser therapy

LIPUS groupMolar distalization group control side

NO INTERVENTION

distalization without LIPUS intervention

LLLT group: distalization intervntion side

EXPERIMENTAL

distalization will be commenced with application of LLLT according to a standardized protocol

Device: low-level laser therapy

LLLT group: distalization control side

NO INTERVENTION

distalization will be commenced without application of LLLT according to a standardized protocol

LIPUS group: leveling and alignment

EXPERIMENTAL

leveling and alignment assisted with LIPUS according to a standardized protocol

Device: low-level laser therapy

LLLT group: leveling and alignment

EXPERIMENTAL

leveling and alignment be commenced with application of LLLT according to a standardized protocol

Device: low-level laser therapy

leveling and alignment without intervention

NO INTERVENTION

leveling and alignment without intervention

LIPUS group: Intrusion

EXPERIMENTAL

intrusion assisted with LIPUS according to a standardized protocol

Device: low-level laser therapy

LLLT group: Intrusion

EXPERIMENTAL

intrusion assisted with application of LLLT according to a standardized protocol

Device: low-level laser therapy

intrusion control group

NO INTERVENTION

intrusion without intervention

Interventions

LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.

Also known as: low intensity pulsed ultrasound
LIPUS group: IntrusionLIPUS group: leveling and alignmentLIPUS groupMolar distalization group inrervention sideLLLT group: IntrusionLLLT group: distalization intervntion sideLLLT group: leveling and alignmentLLLT side canine retractionLipus side: canine retraction

Eligibility Criteria

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

You may qualify if:

  • \- A- leveling and alignment Eligibility criteria
  • \. 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
  • 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

You may not qualify if:

  • \- 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university

Cairo, Egypt

Location

Related Publications (3)

  • Maurya RK, Singh H, Kapoor P, Jain U, Mitra R. Effects of low-level laser and low-intensity pulsed ultrasound therapy on treatment duration and pain perception. J Clin Orthod. 2019 Mar;53(3):154-162. No abstract available.

  • El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.

  • Qamruddin I, Alam MK, Mahroof V, Karim M, Fida M, Khamis MF, Husein A. Biostimulatory Effects of Low-Intensity Pulsed Ultrasound on Rate of Orthodontic Tooth Movement and Associated Pain, Applied at 3-Week Intervals: A Split-Mouth Study. Pain Res Manag. 2021 May 5;2021:6624723. doi: 10.1155/2021/6624723. eCollection 2021.

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2023

First Posted

September 7, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Locations