- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06026930
Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements
Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Alazhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
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
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.