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Status unknownNCT05232318Updated Jan 10, 2023

Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance

An interventional study of Leveling and alignment in Root Resorption, sponsored by Al-Azhar University. Status unknown at 2 sites in Egypt. Open to participants aged 12 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Study summary

The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

Read the detailed description

by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.

02

Conditions studied

  • Root Resorption

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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 30 is close to 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.

04

Who can participate

Ages eligible
12 Years to 19 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

  • Healthy systemic condition/no systemic illness, as reported by patients.
  • No use any form of anti - inflammatory drugs the at beginning of study.
  • Good oral hygiene.
  • Cooperative and motivated.
  • In the permanent dentition with all teeth present ( except third molars).
  • Minimum to moderate anterior crowding.
  • No previous orthodontic treatment.

Exclusion criteria

Exclusion Criteria:

  • Previous upper removable orthodontic treatment.
  • Patients who required surgery to correct skeletal discrepancies.
  • Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
  • Uncooperative patients.
  • Patients with poor oral hygiene.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    leveling and alignment using fixed orthodontic appliance

    leveling and alignment using fixed orthodontic appliance

    Other: Leveling and alignment

  • Experimental
    leveling and alignment using clear aligner

    leveling and alignment using clear aligner

    Other: Leveling and alignment

  • Experimental
    leveling and alignment using clear aligner with low level laser therapy

    leveling and alignment using clear aligner with low level laser therapy

    Other: Leveling and alignment

Interventions

  • OtherLeveling and alignment

    Root resorption comparison through the use of CBCT

06

What researchers measure

Primary outcomes

  1. Amount of Root resorption

    Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software

    Time frame: 8 months

07

Study locations

1 of 2 sites recruiting
  • AlAzhar Azhar University
    Cairo, Or, Egypt
    Recruiting
  • Al Azhar university
    Cairo, Egypt
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Mar 2023, 11 months after the start.

Of 25 interventional studies with no phase under Root Resorption, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 11 months is below that.

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

Registered
Dec 18, 2021
First posted
Feb 9, 2022
StartActual
Apr 1, 2022
Primary completionEst.
Mar 1, 2023
CompletionEst.
Apr 1, 2023
Last update
Jan 10, 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 Jan 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05232318
Lead sponsor
Al-Azhar University
Responsible party
Obaida Khaleel Ibrahim (Principal Investigator, Al-Azhar University) — Principal investigator
First posted
Feb 9, 2022
Start date
Apr 1, 2022
Primary completion
Mar 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Jan 10, 2023

Study contacts

Obaida K Eldlemy
Contact
ObaidaKhalil.209@azhar.edu.eg
+201111488819
Obaida K Eldlemy
Contact
obaida.khalil91@gmail.com
+201111488819
Ahmed M Abouelnour, Lecturer
study director · Lecturer, Department of Orthodontics
Ramadan Y Aboushahba, Associate professor
study chair · Associate professor, Department of Orthodontics

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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