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

Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsedultrasound on Different Orthodontic Tooth Movements During Clearaligner Therapy: A Comparative Clinical Investigation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
• Intervention / Treatment: Device: low intensity pulsed ultrasound and iPRF

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

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Alazhar University

Participation Criteria

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. -

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
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; iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.; Other Names: injectaleplatelets rich fibrin
Experimental: Experimental: iPRF group: Intrusion; intrusion assisted with application of iPRF according to a standardized protocol	Device: low 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.; Other Names: injectaleplatelets rich fibrin
No Intervention: No Intervention: intrusion control group; intrusion without intervention

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	rate of orthodontic tooth movement by millimeter	post interventionalal at 6months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2024
• Primary Completion (Estimated): June 25, 2024
• Study Completion (Estimated): July 25, 2024

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 977/91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No