Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group ToothmovementNCT06498609
Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors
A study testing iprf and MOPs with leveling and alignment in people with Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
- What is being tested?
- iprf and MOPs with leveling and alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- An age range from 15 to 25 years.
- Participants who had a full set of permanent dentitions excluding the third molar.
- Participants who had moderate crowding in the mandibular arch according to Little's irregularity index that necessitates non-extraction treatment in the mandibular arch.
- Normal vertical facial proportions.
- Participants who had good oral hygiene and no periodontal disease.
- No systemic diseases or regular medication that could interfere and/or affect orthodontic teeth movement.
- No evidence of craniofacial anomalies, such as clef lip and palate or previous history of trauma, bruxism, or parafunction.
- No tooth size, shape, or root abnormalities visible on patient's radiographic records.
Who cannot join
- Previous orthodontic treatment.
- Any skeletal dysplasia or craniofacial malformation.
- Retained primary or missing permanent teeth in the anterior area, and any kind of tooth/root shape anomaly or history of trauma affecting the incisors.
- Systemic diseases or regular use of medications that could interfere with OTM.
- Patients with root resorption, impacted canines, or dental anomalies.
- Poor oral hygiene and uncontrolled periodontal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors: A Comparative Clinical Trial
The aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors.
- Conditions
- Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
- Being tested
- iprf, MOPs with leveling and alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iprfBiological
i-PRF with leveling and alignment
MOPs with leveling and alignmentProcedure or surgery
mop
| Study group | Role | What they receive |
|---|---|---|
| Microosteoperforation | Experimental | MOPs with leveling and alignment that will be performed tow time according to standardized protocol Receives: Procedure: MOPs with leveling and alignment |
| Injectable platelet rich fibrin | Experimental | i-PRF with leveling and alignment that will be performed tow time according to standardized protocol Receives: Biological: iprf |
| control group | No intervention | leveling and alignment that will be performed without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of acceleration of leveling and alignment of mandibular incisors
rate of leveling and alignment
Measured: post interventional at 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Nov 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.
- Other trials for Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group ToothmovementStudies 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
- 24 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
- Investigators
- Hasan Fares, Student, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498609
- Sponsor's protocol ID
- 1001/3560
- Status last verified
- May 2024
- First submitted
- 7 Jul 2024
- Last updated
- 12 Jul 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors: A Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06498609
- Acronym / sponsor ID
- 1001/3560
- Conditions
- Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 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 aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microosteoperforation | Experimental | Procedure: MOPs with leveling and alignmentMOPs with leveling and alignment that will be performed tow time according to standardized protocol |
| Injectable platelet rich fibrin | Experimental | Biological: iprfi-PRF with leveling and alignment that will be performed tow time according to standardized protocol |
| control group | No intervention | –leveling and alignment that will be performed without any intervention |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- An age range from 15 to 25 years.
- Participants who had a full set of permanent dentitions excluding the third molar.
- Participants who had moderate crowding in the mandibular arch according to Little's irregularity index that necessitates non-extraction treatment in the mandibular arch.
- Normal vertical facial proportions.
- Participants who had good oral hygiene and no periodontal disease.
Key exclusion criteria (6 listed)
- Previous orthodontic treatment.
- Any skeletal dysplasia or craniofacial malformation.
- Retained primary or missing permanent teeth in the anterior area, and any kind of tooth/root shape anomaly or history of trauma affecting the incisors.
- Systemic diseases or regular use of medications that could interfere with OTM.
- Patients with root resorption, impacted canines, or dental anomalies.
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 |
|---|---|---|
| iprfi-PRF with leveling and alignment | Biological | Injectable platelet rich fibrin |
| MOPs with leveling and alignmentmop | Procedure or surgery | Microosteoperforation |
Primary outcome
assessment of acceleration of leveling and alignment of mandibular incisors
Time frame: post interventional at 4months
rate of leveling and alignment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Hasan Fares, Student principal investigator
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 iprf and MOPs with leveling and alignment in people with Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement, 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 8 inclusion and 6 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 12 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?
assessment of acceleration of leveling and alignment of mandibular incisors (time frame: post interventional at 4months). 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 12 Jul 2024.