Low Level Laser TherapyNCT05811728
Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement
A study testing Low level laser therapy and without beam emission in people with Low Level Laser Therapy and Canine Retraction, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Low Level Laser Therapy, Canine Retraction, Orthodontic Tooth Movement
- What is being tested?
- Low level laser therapy and without beam emission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2023to 31 Aug 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment
Who cannot join
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.
- Being tested
- Low level laser therapy, without beam emission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyRadiation
The low-level laser applied will be a Diode laser* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months).
without beam emissionOther
The laser tip will be held passively on the control side without beam emission, providing a placebo effect.
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Not described Receives: Radiation: Low level laser therapy |
| Control | Placebo comparator | Not described Receives: Other: without beam emission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of alveolar bone density
Bone density will be measured from cone beam computed tomography (CBCT) scans at 2 different locations on each side of the upper arch; between the canine and lateral incisor, and between the canine and second premolar. Bone density will be measured using Hounsfield Units (HU).
Measured: 3 months
Measurement of alveolar bone microstructure
From the CBCT scans, the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be examined. Bone microstructures will be measured and calculated with a dedicated software.
Measured: 3 months
Measurement of buccal bone thickness
buccal bone thickness will be measured from the CBCT scans. Three points will be measured from the buccal bone to the root, at the coronal, mid-root, and apical level
Measured: 3 months
Measurement of alveolar bone volume
From CBCT scans, bone volume in areas of the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be measured
Measured: 3 months
Measurement of bone Microstructure
Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and fractal dimension analysis will be performed using a special software.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start25 Feb 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Laser TherapyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Farah Y Eid, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811728
- Sponsor's protocol ID
- #202
- Status last verified
- Nov 2023
- First submitted
- 1 Apr 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05811728
- Acronym / sponsor ID
- #202
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 13 Apr 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.
Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Radiation: Low level laser therapy |
| Control | Placebo comparator | Other: without beam emission |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment
Key exclusion criteria (3 listed)
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases.
- Pregnancy and lactation.
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 |
|---|---|---|
| Low level laser therapyThe low-level laser applied will be a Diode laser* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months). | Radiation | Low level laser therapy |
| without beam emissionThe laser tip will be held passively on the control side without beam emission, providing a placebo effect. | Other | Control |
Primary outcome
Measurement of alveolar bone density
Time frame: 3 months
Bone density will be measured from cone beam computed tomography (CBCT) scans at 2 different locations on each side of the upper arch; between the canine and lateral incisor, and between the canine and second premolar. Bone density will be measured using Hounsfield Units (HU).
Measurement of alveolar bone microstructure
Time frame: 3 months
From the CBCT scans, the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be examined. Bone microstructures will be measured and calculated with a dedicated software.
Measurement of buccal bone thickness
Time frame: 3 months
buccal bone thickness will be measured from the CBCT scans. Three points will be measured from the buccal bone to the root, at the coronal, mid-root, and apical level
Measurement of alveolar bone volume
Time frame: 3 months
From CBCT scans, bone volume in areas of the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be measured
Measurement of bone Microstructure
Time frame: 3 months
Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and fractal dimension analysis will be performed using a special software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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.
Farah Y Eid, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy and without beam emission in people with Low Level Laser Therapy and Canine Retraction, run by Nourhan M.Aly 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Nov 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of alveolar bone density (time frame: 3 months). The study lists 5 primary outcomes in all. 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 21 Nov 2023.