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Enrolling by invitationNCT05958498Updated Jul 24, 2023

Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforation on Root Resorption During Orthodontic Intrusion of Incisor Teeth

A Phase 1 interventional study of injectable platelet rich fibrin and microosteoperforation in Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors, sponsored by Al-Azhar University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 15 Years to 22 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Al-Azhar University · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
15 Years to 22 Years
Sex
All
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Study summary

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

Read the detailed description

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth: A comparative clinical study

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Conditions studied

  • Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors

Browse trials for

03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

This study's planned enrollment of 18 is below the median of 29 across 36 interventional studies indexed under Root Resorption.

Browse Root Resorption studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Al-Azhar University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Patients with age range between 12-16 years. 2. Overbite > 40% indicated for maxillary intrusion. 3. Mild to moderate crowding of upper incisors. 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.

Exclusion criteria

Exclusion Criteria:

    • Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.
  1. Patients with root resorption, impacted canines, or dental anomalies. 4. Poor oral hygiene 5. Present or history of periodontal diseases. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
  1. History of trauma affecting the maxillary incisors. 8. Endodontically treated upper anterior teeth.
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    Group I

    who will receive intrusive arches after leveling and alignment assisted with i-PRF according to standardized protocol

    Combination Product: injectable platelet rich fibrin and microosteoperforation

  • Active comparator
    Group II

    Will includes 9 patients who will receive intrusive utility arches after leveling and alignment assisted with (MOPs) according to standardized protocol.

    Combination Product: injectable platelet rich fibrin and microosteoperforation

Interventions

  • Combination productinjectable platelet rich fibrin and microosteoperforation

    i-PRF which second product of blood versus mops which is surgical procedure

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What researchers measure

Primary outcomes

  1. to compare the effect of injectable platelets rich fibrin and micro-osteoperforations on root resorption during orthodontic intrusion of incisors.

    amount of root resorption

    Time frame: post interventionalal at 6months

07

Study locations

1 site
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References and documents

Publications

  • Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9. PubMed 33653326 ↗
  • Dos Santos CCO, Mecenas P, de Castro Aragon MLS, Normando D. Effects of micro-osteoperforations performed with Propel system on tooth movement, pain/quality of life, anchorage loss, and root resorption: a systematic review and meta-analysis. Prog Orthod. 2020 Jul 27;21(1):27. doi: 10.1186/s40510-020-00326-4. PubMed 32715352 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for Jun 2024, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2023
First posted
Jul 24, 2023
StartEst.
Dec 2023
Primary completionEst.
Jun 2024
CompletionEst.
Aug 2024
Last update
Jul 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05958498
Lead sponsor
Al-Azhar University
Responsible party
farouk ahmed hussein (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Jul 24, 2023
Start date
Dec 2023 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jul 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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