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

NCT ID: NCT06276985

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-25

Study Completion Date

2024-07-25

Brief Summary

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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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

No Intervention: LIPUS side control side

LIPUS side:closure of premolar extraction space control side

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental:iPRF side closure of premolar extraction space

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

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

iPRF side closure of premolar extraction spacecontrol side

iPRF side canine retraction control side wihout intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental: LIPUS groupMolar distalization group inrervention side

distalization assisted with LIPUS according to a standardized protocol

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

No Intervention: LIPUS groupMolar distalization group control side

distalization without LIPUS intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental: iPRFgroup: distalization intervntion side

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

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

No Intervention: iPRF group: distalization control side

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental: LIPUS group: leveling and alignment

leveling and alignment assisted with LIPUS according to a standardized protocol

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

Experimental: iPRF group: leveling and alignment

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

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

No Intervention: leveling and alignment without intervention

leveling and alignment without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental: LIPUS group: Intrusion

intrusion assisted with LIPUS according to a standardized protocol

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

Experimental: iPRF group: Intrusion

intrusion assisted with application of iPRF according to a standardized protocol

Group Type EXPERIMENTAL

low intensity pulsed ultrasound and iPRF

Intervention Type DEVICE

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

No Intervention: intrusion control group

intrusion without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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injectaleplatelets rich fibrin

Eligibility Criteria

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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


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

\-
Minimum Eligible Age

15 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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farouk ahmed hussein

prinicpaI Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AlAzhar university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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977/91

Identifier Type: -

Identifier Source: org_study_id

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