Effect of Platelet Rich Fibrin With Different Tooth MovementsPhase 1/2NCT05616936
Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin
A Phase 1/2 study testing injectable platelet rich fibrin in people with Effect of Platelet Rich Fibrin With Different Tooth Movements, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases 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 With Different Tooth Movements
- What is being tested?
- injectable platelet rich fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Apr 2023
- Phase
- Phase 1/2
- 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
Inclusion Criteria:An age range from 15-22 years. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
All permanent teeth present, 3rd molars are excluded. Good oral and general health. No systemic disease/medication that could interfere with orthodontic tooth movement. No previous orthodontic treatment.
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Exclusion Criteria:Patient diagnosed to have an indication for non-extraction approach.
Poor oral hygiene or periodontally compromised patient. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study
The present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases
Read the detailed description
Assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases
- Being tested
- injectable platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectable platelet rich fibrinBiological
injectable platelet rich fibrin
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Intervention side: application of i-PRF with distalization of maxillary first molar that will be performed on intervention sides according to a standardized protocol. Receives: Biological: injectable platelet rich fibrin |
| Group II | No intervention | Control side: distalization of maxillary first molar that will be performed without any intervention |
| Group A | Experimental | levelling and alignment assisted with Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol. Receives: Biological: injectable platelet rich fibrin |
| Group B | No intervention | leveling and alignment will be commenced without Injection of Injectable platelet-rich fibrin (i-PRF) |
| Group a | Experimental | Will includes 9 patients who will receive intrusive arch after leveling and alignment assisted Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol. Receives: Biological: injectable platelet rich fibrin |
| Group b | No intervention | Will includes 9 patients who will receive intrusive utility arches after leveling and alignment without Injection of Injectable platelet-rich fibrin (i-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of injectable platelet rich fibrin on different tooth movements
rate of tooth movement
Measured: post interventional at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effect of Platelet Rich Fibrin With Different Tooth MovementsStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial Assignment
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT05616936
- Sponsor's protocol ID
- 837/140
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
PubMed 33481053Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
PubMed 33459765
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05616936
- Acronym / sponsor ID
- 837/140
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 15 Nov 2022 (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 present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases
Detailed description
Assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Factorial Assignment
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Biological: injectable platelet rich fibrinIntervention side: application of i-PRF with distalization of maxillary first molar that will be performed on intervention sides according to a standardized protocol. |
| Group II | No intervention | –Control side: distalization of maxillary first molar that will be performed without any intervention |
| Group A | Experimental | Biological: injectable platelet rich fibrinlevelling and alignment assisted with Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol. |
| Group B | No intervention | –leveling and alignment will be commenced without Injection of Injectable platelet-rich fibrin (i-PRF) |
| Group a | Experimental | Biological: injectable platelet rich fibrinWill includes 9 patients who will receive intrusive arch after leveling and alignment assisted Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol. |
| Group b | No intervention | –Will includes 9 patients who will receive intrusive utility arches after leveling and alignment without Injection of Injectable platelet-rich fibrin (i-PRF) |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| injectable platelet rich fibrininjectable platelet rich fibrin | Biological | Group A, Group I, Group a |
Primary outcome
effect of injectable platelet rich fibrin on different tooth movements
Time frame: post interventional at 4 months
rate of tooth movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 33481053Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.
- Background: PubMed 33459765Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.
- Individual participant dataSharing planned: No
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 Phase 1/2 study testing injectable platelet rich fibrin in people with Effect of Platelet Rich Fibrin With Different Tooth Movements, 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?
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 15 Nov 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
effect of injectable platelet rich fibrin on different tooth movements (time frame: post interventional at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616936, which also lists 2 linked publications.
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 15 Nov 2022.