Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner TherapyNCT06276985
Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy
A study testing low intensity pulsed ultrasound and iPRF in people with Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy, run by Al-Azhar University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
- What is being tested?
- low intensity pulsed ultrasound and iPRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2024to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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. -
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
- Being tested
- low intensity pulsed ultrasound and iPRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity pulsed ultrasound and iPRFDevice
Also called injectaleplatelets rich fibrin
iPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Lipus side: closure of premolar extraction space | Experimental | application of LIPUS with translation of closure of premolar extraction space that will be performed on intervention sides according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| No Intervention: LIPUS side control side | No intervention | LIPUS side:closure of premolar extraction space control side |
| Experimental:iPRF side closure of premolar extraction space | Experimental | closure ofpremolar extraction space that will be performed with iPRFapplication according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| iPRF side closure of premolar extraction spacecontrol side | No intervention | iPRF side canine retraction control side wihout intervention |
| Experimental: LIPUS groupMolar distalization group inrervention side | Experimental | distalization assisted with LIPUS according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| No Intervention: LIPUS groupMolar distalization group control side | No intervention | distalization without LIPUS intervention |
| Experimental: iPRFgroup: distalization intervntion side | Experimental | distalization will be commenced with application of iPRF according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| No Intervention: iPRF group: distalization control side | No intervention | distalization will be commenced without application of LLLT according to a standardized protocol |
| Experimental: LIPUS group: leveling and alignment | Experimental | leveling and alignment assisted with LIPUS according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| Experimental: iPRF group: leveling and alignment | Experimental | leveling and alignment be commenced with application of iPRF according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| No Intervention: leveling and alignment without intervention | No intervention | leveling and alignment without intervention |
| Experimental: LIPUS group: Intrusion | Experimental | intrusion assisted with LIPUS according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| Experimental: iPRF group: Intrusion | Experimental | intrusion assisted with application of iPRF according to a standardized protocol Receives: Device: low intensity pulsed ultrasound and iPRF |
| No Intervention: intrusion control group | No intervention | intrusion without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post interventionalal at 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start25 Feb 2024 (estimated)
- Primary completion25 Jun 2024 (estimated)
- Study completion25 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner TherapyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, farouk ahmed hussein, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276985
- Sponsor's protocol ID
- 977/91
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsedultrasound on Different Orthodontic Tooth Movements During Clearaligner Therapy: A Comparative Clinical Investigation
- ClinicalTrials.gov ID
- NCT06276985
- Acronym / sponsor ID
- 977/91
- Conditions
- Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 25 Jul 2024 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lipus side: closure of premolar extraction space | Experimental | Device: low intensity pulsed ultrasound and iPRFapplication of LIPUS with translation of closure of premolar extraction space that will be performed on intervention sides according to a standardized protocol |
| No Intervention: LIPUS side control side | No intervention | –LIPUS side:closure of premolar extraction space control side |
| Experimental:iPRF side closure of premolar extraction space | Experimental | Device: low intensity pulsed ultrasound and iPRFclosure ofpremolar extraction space that will be performed with iPRFapplication according to a standardized protocol |
| iPRF side closure of premolar extraction spacecontrol side | No intervention | –iPRF side canine retraction control side wihout intervention |
| Experimental: LIPUS groupMolar distalization group inrervention side | Experimental | Device: low intensity pulsed ultrasound and iPRFdistalization assisted with LIPUS according to a standardized protocol |
| No Intervention: LIPUS groupMolar distalization group control side | No intervention | –distalization without LIPUS intervention |
| Experimental: iPRFgroup: distalization intervntion side | Experimental | Device: low intensity pulsed ultrasound and iPRFdistalization will be commenced with application of iPRF according to a standardized protocol |
| No Intervention: iPRF group: distalization control side | No intervention | –distalization will be commenced without application of LLLT according to a standardized protocol |
| Experimental: LIPUS group: leveling and alignment | Experimental | Device: low intensity pulsed ultrasound and iPRFleveling and alignment assisted with LIPUS according to a standardized protocol |
| Experimental: iPRF group: leveling and alignment | Experimental | Device: low intensity pulsed ultrasound and iPRFleveling and alignment be commenced with application of iPRF according to a standardized protocol |
| No Intervention: leveling and alignment without intervention | No intervention | –leveling and alignment without intervention |
| Experimental: LIPUS group: Intrusion | Experimental | Device: low intensity pulsed ultrasound and iPRFintrusion assisted with LIPUS according to a standardized protocol |
| Experimental: iPRF group: Intrusion | Experimental | Device: low intensity pulsed ultrasound and iPRFintrusion assisted with application of iPRF according to a standardized protocol |
| No Intervention: intrusion control group | No intervention | –intrusion without intervention |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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 -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low intensity pulsed ultrasound and iPRFAlso: injectaleplatelets rich fibriniPRF and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation. | Device | Experimental: LIPUS group: Intrusion, Experimental: LIPUS group: leveling and alignment, Experimental: LIPUS groupMolar distalization group inrervention side, Experimental: Lipus side: closure of premolar extraction space, Experimental: iPRF group: Intrusion, Experimental: iPRF group: leveling and alignment, Experimental: iPRFgroup: distalization intervntion side, Experimental:iPRF side closure of premolar extraction space |
Primary outcome
Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter
Time frame: post interventionalal at 6months
rate of orthodontic tooth movement by millimeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity pulsed ultrasound and iPRF in people with Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter (time frame: post interventionalal at 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.