Effects of; Movement of Teeth Assiste Wit MOPS and I-prfPhase 2NCT05960825

Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin

A Phase 2 study testing injectable platelet rich fibrin versus microosteoperforation in people with Effects of; Movement of Teeth Assiste Wit MOPS and I-prf, run by Al-Azhar University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The present clinical comparative study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with microosteoperforations versus injectable platelet rich fibrin. Read more about this study

Who is it for?: Ages 15 to 22 yearsHealthy volunteers can take part
Conditions the study is for: Effects of; Movement of Teeth Assiste Wit MOPS and I-prf
What is being tested?: injectable platelet rich fibrin versus microosteoperforation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteEgypt
Study dates: Dec 2023to Aug 2024
Phase: Phase 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

Who may be able to join

An age ranges 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 OTM.
No previous orthodontic treatment.

Who cannot join

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.
Previous orthodontic treatment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

AlAzhar university
Cairo

Other trials in Egypt

About this study

Official title: Assessment of Two Different Modalities of Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin: A Comparative Clinical Study

Read the detailed description

Group I: will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.

▪ Group II: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol.

Conditions: Effects of; Movement of Teeth Assiste Wit MOPS and I-prf
Being tested: injectable platelet rich fibrin versus microosteoperforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

injectable platelet rich fibrin versus microosteoperforationCombination product
injectable platelet rich fibrin which is second product of blood versus microosteoperforation which is surgical procedure

Study groups in NCT05960825
Study group	Role	What they receive
Group MOPs	Experimental	Group MOPs : will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol. Receives: Combination Product: injectable platelet rich fibrin versus microosteoperforation
Group IMOPS	No intervention	other side in group which is control group
Group i-PRF	Experimental	group i-PRF: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol Receives: Combination Product: injectable platelet rich fibrin versus microosteoperforation
group i-PRF2	No intervention	other side in group which is control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation period and on every 28 days observation period according to standardized method
Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation and every 28 days period and on every 28 days observation period according to standardized method. 2. Study cast assessment:
- The amount of maxillary canine retraction on both sides will be measured immediately before starting canine retraction and at each observation interval by using a software for the scanned models according to standardized method
Measured: 4months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2023Aug 2024

First posted27 Jul 2023
Study startDec 2023 (estimated)
Primary completionMar 2024 (estimated)
Study completionAug 2024 (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 Effects of; Movement of Teeth Assiste Wit MOPS and I-prfStudies 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05960825
Sponsor's protocol ID: 857/140
Status last verified: Jul 2023
First submitted: 15 Jul 2023
Last updated: 27 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PubMed 24182579
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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Two Different Modalities of Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin: A Comparative Clinical Study
ClinicalTrials.gov ID: NCT05960825
Acronym / sponsor ID: 857/140
Conditions: Effects of; Movement of Teeth Assiste Wit MOPS and I-prf
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 18 participants (estimated)
Lead sponsor: Al-Azhar UniversityUniversity, hospital or other
Study start: Dec 2023 (estimated)
Primary completion: Mar 2024 (estimated)
Study completion: Aug 2024 (estimated)
First posted: 27 Jul 2023 (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.

Detailed description

Group I: will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.

▪ Group II: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group MOPs	Experimental	Combination Product: injectable platelet rich fibrin versus microosteoperforationGroup MOPs : will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.
Group IMOPS	No intervention	–other side in group which is control group
Group i-PRF	Experimental	Combination Product: injectable platelet rich fibrin versus microosteoperforationgroup i-PRF: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol
group i-PRF2	No intervention	–other side in group which is control group

Who may qualify

Ages: 15 to 22 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

An age ranges 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 OTM.

Key exclusion criteria (4 listed)

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.
Previous orthodontic treatment.

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 fibrin versus microosteoperforationinjectable platelet rich fibrin which is second product of blood versus microosteoperforation which is surgical procedure	Combination product	Group MOPs, Group i-PRF

Primary outcome

Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation period and on every 28 days observation period according to standardized method
Time frame: 4months
Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation and every 28 days period and on every 28 days observation period according to standardized method. 2. Study cast assessment: • The amount of maxillary canine retraction on both sides will be measured immediately before starting canine retraction and at each observation interval by using a software for the scanned models according to standardized method

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Results publication: PubMed 24182579Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
Results publication: 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.
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?

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 6 inclusion and 4 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 27 Jul 2023. 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 phase mean?

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?

Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation period and on every 28 days observation period according to standardized method (time frame: 4months). 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 NCT05960825, 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 27 Jul 2023.