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Enrolling by invitationNCT06276985Updated Feb 26, 2024

Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy

An interventional study of low intensity pulsed ultrasound and iPRF in Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy, sponsored by Al-Azhar University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 15 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
15 Years to 22 Years
Sex
All
01

Study summary

The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy.

Read the detailed description

The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy.specifically canine retraction,incsiors levellingand aliggnment,maxillary molar distalizationand incisors intrusion

02

Conditions studied

  • Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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. -

-

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Experimental: Lipus side: closure of premolar extraction space

    application of LIPUS with translation of closure of premolar extraction space that will be performed on intervention sides according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    No Intervention: LIPUS side control side

    LIPUS side:closure of premolar extraction space control side

  • Experimental
    Experimental:iPRF side closure of premolar extraction space

    closure ofpremolar extraction space that will be performed with iPRFapplication according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    iPRF side closure of premolar extraction spacecontrol side

    iPRF side canine retraction control side wihout intervention

  • Experimental
    Experimental: LIPUS groupMolar distalization group inrervention side

    distalization assisted with LIPUS according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    No Intervention: LIPUS groupMolar distalization group control side

    distalization without LIPUS intervention

  • Experimental
    Experimental: iPRFgroup: distalization intervntion side

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

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    No Intervention: iPRF group: distalization control side

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

  • Experimental
    Experimental: LIPUS group: leveling and alignment

    leveling and alignment assisted with LIPUS according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • Experimental
    Experimental: iPRF group: leveling and alignment

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

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    No Intervention: leveling and alignment without intervention

    leveling and alignment without intervention

  • Experimental
    Experimental: LIPUS group: Intrusion

    intrusion assisted with LIPUS according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • Experimental
    Experimental: iPRF group: Intrusion

    intrusion assisted with application of iPRF according to a standardized protocol

    Device: low intensity pulsed ultrasound and iPRF

  • No intervention
    No Intervention: intrusion control group

    intrusion without intervention

Interventions

  • Devicelow intensity pulsed ultrasound and iPRF

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

    Also known as: injectaleplatelets rich fibrin

06

What researchers measure

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

    Time frame: post interventionalal at 6months

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Study locations

1 site
  • AlAzhar university
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06276985
Lead sponsor
Al-Azhar University
Responsible party
farouk ahmed hussein (prinicpaI Investigator, Al-Azhar University) — Principal investigator
First posted
Feb 26, 2024
Start date
Feb 25, 2024 (estimated)
Primary completion
Jun 25, 2024 (estimated)
Completion
Jul 25, 2024 (estimated)
Last update
Feb 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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