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

Sponsor
Al-Azhar University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06026930
Collaborator
(none)
82
1
14
7
11.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: low-level laser therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Device: low-level laser therapy
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: LLLT side canine retraction

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

    Device: low-level laser therapy
    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: LIPUS groupMolar distalization group inrervention side

    distalization assisted with LIPUS according to a standardized protocol

    Device: low-level laser therapy
    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: LLLT group: distalization intervntion side

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

    Device: low-level laser therapy
    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: LIPUS group: leveling and alignment

    leveling and alignment assisted with LIPUS according to a standardized protocol

    Device: low-level laser therapy
    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: LLLT group: leveling and alignment

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

    Device: low-level laser therapy
    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

    leveling and alignment without intervention

    Experimental: LIPUS group: Intrusion

    intrusion assisted with LIPUS according to a standardized protocol

    Device: low-level laser therapy
    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: LLLT group: Intrusion

    intrusion assisted with application of LLLT according to a standardized protocol

    Device: low-level laser therapy
    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

    Outcome Measures

    Primary Outcome Measures

    1. Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter [post interventionalal at 6months]

      rate of orthodontic tooth movement by millimeter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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;
    1. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that could interfere with otm. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AlAzhar university Cairo Egypt

    Sponsors and Collaborators

    • Al-Azhar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    farouk ahmed hussein, Principal Investigator, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT06026930
    Other Study ID Numbers:
    • 926/91
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 7, 2023