Dental MalocclusionNCT04376164
Laser in Orthodontic Leveling and Alignment
A study testing low level laser therapy in people with Dental Malocclusion, run by Tharwat osman Mohi Eldeen Elshehawy at 1 site in Egypt.
Trial summary
to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 15 Jul 2018
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Selection of participants was based on the following criteria:
- The age range was from 15 to 25 years.
- All permanent teeth erupted (3rd molar not included).
- Angle class I occlusion with normal facial proportions.
- Moderate crowding in the lower dental arch assessed by Little's irregularity index that requires treatment with fixed appliance using non-extraction approach.
- Good oral and general health.
Show all 10Show fewer
- No previous or current periodontal disease.
- No systemic disease or regular medication that could interfere and\or affects orthodontic teeth movement.
- No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunction.
- No previous orthodontic treatment.
Who cannot join
- The patients were excluded from the study if they have:
- Severe crowding that requires an extraction approach.
- Blocked-out teeth that didn't allow for placement of the bracket at the initial bonding appointment.
- Poor oral hygiene or periodontally compromised teeth.
- Relevant medical history that interferes with orthodontic treatment.
- Craniofacial anomalies or previous history of trauma, bruxism or parafunction.
- Previous orthodontic treatment.
- The deep bite which interferes with orthodontic brackets placement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal
to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.
Read the detailed description
Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly divided into two parallel groups; a control group without laser intervention and a laser group which received LLLT. All patients followed a non-extraction approach using one category of fixed appliance and matching conventional NiTi archwire sequence during 3 months observation period. In laser group, mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months. In both groups, relief of mandibular crowding was assessed by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12 weeks (T3) intervals. Changes in LII scores were evaluated through scanned 3D models via software. In addition, the monthly rate of OTM was calculated and compared. The level of significance was set at p ≤ 0.05.
- Conditions
- Dental Malocclusion
- Being tested
- low level laser therapy
- Keywords
- Low-level laser therapy, Orthodontic Tooth Movement, Leveling and Alignment, Little Irregularity Index.
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyRadiation
Also called photobiomodulation
mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | was treated without laser intervention |
| laser group | Experimental | received low level laser therapy Receives: Radiation: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy
Effect of the LLLT on alignment of the mandibular anterior teeth through evaluation of changes in Little's Irregularity Index (LII) scores (mm) throughout 12 weeks observation period of the study
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jan 2018
- Primary completion10 Jun 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies 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
- Model description
- control group laser group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tharwat osman Mohi Eldeen Elshehawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tharwat osman Mohi Eldeen Elshehawy, Al-Azhar University
- Investigators
- tharwat O elshehay, MSc student, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376164
- Sponsor's protocol ID
- 101
- Status last verified
- May 2020
- First submitted
- 2 May 2020
- Last updated
- 6 May 2020
- 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 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Low-level Laser Therapy Regarding Orthodontic Leveling and Alignment of Mandibular Anterior Segment: A Controlled Clinical Appraisal
- ClinicalTrials.gov ID
- NCT04376164
- Acronym / sponsor ID
- 101
- Conditions
- Dental Malocclusion
- Keywords
- Low-level laser therapy, Orthodontic Tooth Movement, Leveling and Alignment, Little Irregularity Index.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tharwat osman Mohi Eldeen ElshehawyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 6 May 2020 (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.
to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior segment.
Detailed description
Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly divided into two parallel groups; a control group without laser intervention and a laser group which received LLLT. All patients followed a non-extraction approach using one category of fixed appliance and matching conventional NiTi archwire sequence during 3 months observation period. In laser group, mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months. In both groups, relief of mandibular crowding was assessed by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12 weeks (T3) intervals. Changes in LII scores were evaluated through scanned 3D models via software. In addition, the monthly rate of OTM was calculated and compared. The level of significance was set at p ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group laser group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –was treated without laser intervention |
| laser group | Experimental | Radiation: low level laser therapyreceived low level laser therapy |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Selection of participants was based on the following criteria:
Key exclusion criteria (8 listed)
- The patients were excluded from the study if they have:
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 therapyAlso: photobiomodulationmandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months | Radiation | laser group |
Primary outcome
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy
Time frame: 6 Months
Effect of the LLLT on alignment of the mandibular anterior teeth through evaluation of changes in Little's Irregularity Index (LII) scores (mm) throughout 12 weeks observation period of the study
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 6 May 2020.
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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.
tharwat O elshehay, MSc student principal investigator
Al-Azhar University
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 in people with Dental Malocclusion, run by Tharwat osman Mohi Eldeen Elshehawy 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 10 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: finished, as of the sponsor's last update on 6 May 2020. 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?
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?
Evaluation of the alignment rate of the mandibular anterior segment with and without low level laser therapy (time frame: 6 Months). 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 6 May 2020.