Rate of Canine RetractionNCT06520761
The Effect of Injectable PRF Vs LLL on Orthodontic Tooth Movement
A study testing Injectable platelet rich fibrin and Low Level LASER in people with Rate of Canine Retraction and Root Resorption, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
The purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rate of Canine Retraction, Root Resorption
- What is being tested?
- Injectable platelet rich fibrin and Low Level LASER
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Dec 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with age 18 years or older.
- Presence of all permanent teeth except for the third molar.
- Presence of malocclusion requiring maxillary first premolar extraction such as (class II division 1 or bimaxillary dentoalveolar protrusion).
Who cannot join
- Patient with a history of previous orthodontic treatment.
- Medical problems may interfere with orthodontic treatment.
- Bad oral hygiene.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls Al Azhar university
Cairo, Naser City, 02
About this study
Official title: The Effect of Injectable Platelet Rich Fibrin Versus Low-Level LASER Therapy on The Rate of Orthodontic Tooth Movement
The purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine
Read the detailed description
the study involves two groups the first group received low level laser at the upper right canine, while the upper left canine act as a control. The second group received injectable platelet rich fibrin at the upper right canine, while the upper left canine act as a control. in each group we will compare rate of canine retraction between both sides, and amount of root resorption also we will compare both groups regarding rate of canine retraction and amount of root resorption
- Conditions
- Rate of Canine Retraction, Root Resorption
- Being tested
- Injectable platelet rich fibrin, Low Level LASER
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable platelet rich fibrinProcedure or surgery
blood sample obtained from the participant, centrifuged at 700 rpm to produce injectable platelet rich fibrin, this will be injected around the upper canine
Low Level LASERDevice
Diode LASER device is used to apply Low Level LASER around the upper canine
| Study group | Role | What they receive |
|---|---|---|
| injectable platelet rich fibrin | Experimental | blood sample is collected from the patient, centrifuged at 700rpm for 3 minutes then the resulted injectable platelet rich fibrin is injected around the upper right canine while the upper left canine act as a control Receives: Procedure: Injectable platelet rich fibrin |
| Low Level LASER | Experimental | low level laser from diode laser machine is applied around the upper right canine and the upper left canine acts as a control Receives: Device: Low Level LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
measure the rate of distal movement of the upper canine
Measured: 4 month
Secondary outcomes (1)
Root resorption of upper canine
measure root resorption of upper canine
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rate of Canine RetractionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samir A Ebrahim, Professor, Principal investigator, Head of orthodontic department at faculty of Dental Medicine for Girls Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520761
- Sponsor's protocol ID
- ORTHO-108-5-b
- Status last verified
- Oct 2023
- First submitted
- 20 Jul 2024
- Last updated
- 25 Jul 2024
- 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 33481053
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injectable Platelet Rich Fibrin Versus Low-Level LASER Therapy on The Rate of Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT06520761
- Acronym / sponsor ID
- ORTHO-108-5-b
- Conditions
- Rate of Canine Retraction, Root Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Jul 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 purpose of the present study is to compare the effect of injectable platelet fibrin and Low Level LASER therapy on the rate of upper canine retraction, and on root resorption of the canine
Detailed description
the study involves two groups the first group received low level laser at the upper right canine, while the upper left canine act as a control. The second group received injectable platelet rich fibrin at the upper right canine, while the upper left canine act as a control. in each group we will compare rate of canine retraction between both sides, and amount of root resorption also we will compare both groups regarding rate of canine retraction and amount of root resorption
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable platelet rich fibrin | Experimental | Procedure: Injectable platelet rich fibrinblood sample is collected from the patient, centrifuged at 700rpm for 3 minutes then the resulted injectable platelet rich fibrin is injected around the upper right canine while the upper left canine act as a control |
| Low Level LASER | Experimental | Device: Low Level LASERlow level laser from diode laser machine is applied around the upper right canine and the upper left canine acts as a control |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with age 18 years or older.
- Presence of all permanent teeth except for the third molar.
- Presence of malocclusion requiring maxillary first premolar extraction such as (class II division 1 or bimaxillary dentoalveolar protrusion).
Key exclusion criteria (3 listed)
- Patient with a history of previous orthodontic treatment.
- Medical problems may interfere with orthodontic treatment.
- Bad oral hygiene.
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 fibrinblood sample obtained from the participant, centrifuged at 700 rpm to produce injectable platelet rich fibrin, this will be injected around the upper canine | Procedure or surgery | injectable platelet rich fibrin |
| Low Level LASERDiode LASER device is used to apply Low Level LASER around the upper canine | Device | Low Level LASER |
Primary outcome
Rate of canine retraction
Time frame: 4 month
measure the rate of distal movement of the upper canine
1 secondary outcome
Root resorption of upper canine
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- 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.
- The role of platelet-rich fibrin (PRF) in accelerating orthodontic tooth movement has been controversially discussed in available clinical studies. Objective: To investigate the effectiveness of i-PRF in accelerating maxillary canine retraction.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Samir A Ebrahim, Professor principal investigator
Head of orthodontic department at faculty of Dental Medicine for Girls Al-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable platelet rich fibrin and Low Level LASER in people with Rate of Canine Retraction and Root Resorption, run by Faculty of Dental Medicine for Girls 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 3 inclusion and 3 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 25 Jul 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?
Rate of canine retraction (time frame: 4 month). 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 NCT06520761, which also lists 1 linked publication.
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 25 Jul 2024.