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

Not Applicable

• Conditions: Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
• Interventions: Device: low intensity pulsed ultrasound and iPRF

• Registration Number: NCT06276985
• Lead Sponsor: Al-Azhar University

Brief 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.

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Last Update Submitted: 2024-02-18
• Study Start: 2024-02-25
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-06-25
• Study Completion: 2024-07-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental: LIPUS group: Intrusion	low intensity pulsed ultrasound and iPRF	intrusion assisted with LIPUS according to a standardized protocol
Experimental: LIPUS group: leveling and alignment	low intensity pulsed ultrasound and iPRF	leveling and alignment assisted with LIPUS according to a standardized protocol
Experimental: iPRFgroup: distalization intervntion side	low intensity pulsed ultrasound and iPRF	distalization will be commenced with application of iPRF according to a standardized protocol
Experimental: LIPUS groupMolar distalization group inrervention side	low intensity pulsed ultrasound and iPRF	distalization assisted with LIPUS according to a standardized protocol
Experimental: iPRF group: Intrusion	low intensity pulsed ultrasound and iPRF	intrusion assisted with application of iPRF according to a standardized protocol
Experimental: Lipus side: closure of premolar extraction space	low intensity pulsed ultrasound and iPRF	application of LIPUS with translation of closure of premolar extraction space that will be performed on intervention sides according to a standardized protocol
Experimental:iPRF side closure of premolar extraction space	low intensity pulsed ultrasound and iPRF	closure ofpremolar extraction space that will be performed with iPRFapplication according to a standardized protocol
Experimental: iPRF group: leveling and alignment	low intensity pulsed ultrasound and iPRF	leveling and alignment be commenced with application of iPRF according to a standardized protocol

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AlAzhar university; 🇪🇬 Cairo, Egypt