Root Resorption of Maxillary IncisorsNCT05707416
Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors
A study testing gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland) and group B in people with Root Resorption of Maxillary Incisors, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Resorption of Maxillary Incisors
- What is being tested?
- gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland) and group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 20 Dec 2023
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors: A Comparative Clinical Study
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
- Root Resorption of Maxillary Incisors
- Being tested
- gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland), group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)Device
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
group BOther
Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | 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 Receives: Device: gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland) |
| Control group | Active comparator | Will includes 9 patients who will receive intrusive arches after leveling and alignment without laser application Receives: Other: group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear amount of root resorption
cone beam computed linear measurements
Measured: change in linear root resorption at 4 months
volumetric amount of root resorption
cone beam computed volumetric measurements
Measured: change in volumetric root resorption at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start15 Dec 2022
- Primary completion15 May 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root Resorption of Maxillary IncisorsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssri Mahmoud Ahmed Saleh, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707416
- Sponsor's protocol ID
- 796/2193
- Status last verified
- Jan 2023
- First submitted
- 22 Nov 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT05707416
- Acronym / sponsor ID
- 796/2193
- Conditions
- Root Resorption of Maxillary Incisors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 1 Feb 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.
The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Device: gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland)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 |
| Control group | Active comparator | Other: group BWill includes 9 patients who will receive intrusive arches after leveling and alignment without laser application |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients with age range between 12-16 years.
Key exclusion criteria (8 listed)
- Transverse and/or vertical skeletal dysplasia or craniofacial malformation.
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 |
|---|---|---|
| gallium 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 | Device | Experimental group |
| group BWill includes 9 patients who will receive intrusive arches after leveling and alignment without laser application | Other | Control group |
Primary outcome
linear amount of root resorption
Time frame: change in linear root resorption at 4 months
cone beam computed linear measurements
volumetric amount of root resorption
Time frame: change in volumetric root resorption at 4 months
cone beam computed volumetric measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 25737942Goel 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.
- Individual participant dataSharing planned: No
Related trials for Root Resorption of Maxillary Incisors
Recruiting
Maxillary Incisor Intrusion Using Utility Arch Assisted With Micro-osteoperforations
Deep Bite Malocclusion, Intrusion of Tooth
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?
A study testing gallium aluminum arsenide (Ga-Al-As) semiconductor diode laser (SMARTTM PRO, LASOTRONIX, Poland) and group B in people with Root Resorption of Maxillary Incisors, 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 6 inclusion and 8 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 1 Feb 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.
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?
linear amount of root resorption (time frame: change in linear root resorption at 4 months). The study lists 2 primary outcomes in all. 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 NCT05707416, which also lists 1 linked publication.
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 1 Feb 2023.