Status unknownNCT05707416Updated Feb 1, 2023

Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors

An interventional study of gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland) and group B in Root Resorption of Maxillary Incisors, sponsored by Al-Azhar University. Status unknown at 1 site in Egypt. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.

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this record recently (last verified Jan 2023), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 12 Years to 16 Years
Sex: All

Study summary

The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.

Conditions studied

Root Resorption of Maxillary Incisors

Browse trials for

Root Resorption 43

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.

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

Who can participate

Ages eligible: 12 Years to 16 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

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 18 participants (estimated)

Study arms

Active comparator
Experimental group
Will includes 9 patients who will receive intrusive arche after leveling and alignment assisted with laser with wavelength 635 nm, 6.5J/cm2,The laser will be applied to 4 points of application for each tooth two labial and two palatal started immediately after first intrusive wire then at days 3,7,14 and then every 15 day until achievement of the study objectives
Device: gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)
Active comparator
Control group
Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application
Other: group B

Interventions

Devicegallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)
The laser will be applied to 4 points of application for each tooth two labial and two palatal started immediately after first intrusive wire then at days 3,7,14 and then every 15 day until achievement of the study objectives
Othergroup B
Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application

What researchers measure

Primary outcomes

linear amount of root resorption
cone beam computed linear measurements
Time frame: change in linear root resorption at 4 months
volumetric amount of root resorption
cone beam computed volumetric measurements
Time frame: change in volumetric root resorption at 4 months

Study locations

1 site

Al Azhar Univertsity
Naşr, Egypt

References and documents

Publications

Goel P, Tandon R, Agrawal KK. A comparative study of different intrusion methods and their effect on maxillary incisors. J Oral Biol Craniofac Res. 2014 Sep-Dec;4(3):186-91. doi: 10.1016/j.jobcr.2014.11.007. Epub 2014 Dec 6. PubMed 25737942 ↗

Individual participant data

Plan to share: No

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 Dec 2022 (actual). Primary completion is estimated for May 2023, 5 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 5 months is below that.

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

Registered: Nov 22, 2022
First posted: Feb 1, 2023
StartActual: Dec 15, 2022
Primary completionEst.: May 15, 2023
CompletionEst.: Dec 20, 2023
Last update: Feb 1, 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 Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05707416
Lead sponsor: Al-Azhar University
Responsible party: Youssri Mahmoud Ahmed Saleh (doctor, Al-Azhar University) — Principal investigator
First posted: Feb 1, 2023
Start date: Dec 15, 2022
Primary completion: May 15, 2023 (estimated)
Completion: Dec 20, 2023 (estimated)
Last update: Feb 1, 2023

Oversight

Data monitoring committee: Yes
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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