Dental MalocclusionNCT04381442
Effect of Low Level Laser on Orthodontic Canine Retraction
A study testing Low Level Laser Therapy in people with Dental Malocclusion, run by Al-Azhar University.
Trial summary
The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- 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
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to 24 Feb 2019
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Complete permanent dentition (3rd molars excluded).
- The age was ranged from 15 -25 years.
- Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction.
- Good oral hygiene and periodontal health.
Who cannot join
- Patients who diagnosed to have an indication for non-extraction approach.
- Serious systemic diseases and/or long term medications that could interfere with OTM.
- Previous orthodontic treatment.
- Poor oral hygiene or periodontally compromised patients.
- Craniofacial anomalies or history of parafunctional habits.
About this study
Official title: Consequence of Two Protocols and Energy Doses of Low Level Laser Therapy on the Rate of Orthodontic Canine Retraction: A Prospective Clinical Evaluation
The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement.
Read the detailed description
Fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years were included. They had a clinical indication for bilateral extraction of at least first maxillary premolars. Using a split mouth design, maxillary left and right sides were randomly divided into two groups. In group 1, LLLT was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. In group II, laser was applied from buccal side only at 5 points through the same order with a dose of 4 J per session. In both protocols, maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point. Both sides were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring. In both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Amount and monthly rate of maxillary canine retraction and degree of anchorage loss were determined by direct intraoral and indirect 3D digital models measurements. Evaluations were undertaken immediately before initiating retraction (T0), after 4 weeks (T1), after 8 weeks (T2), after 12 weeks (T3), after 16 weeks (T4), after 20 weeks (T5), and after 24 weeks (T6). Significance level was set at p < 0.05.
- Conditions
- Dental Malocclusion
- Being tested
- Low Level Laser Therapy
- Keywords
- Low Level Laser Therapy, Orthodontic Tooth movement, Canine Retraction, Two Protocols and Energy Doses
- 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
| Study group | Role | What they receive |
|---|---|---|
| Buccal &palatal low level laser therapy | Experimental | In group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Receives: Radiation: Low Level Laser Therapy |
| Buccal low level laser therapy | Active comparator | In group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Receives: Radiation: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the rate of maxillary canine retraction
Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models
Measured: 6 Months
Secondary outcomes (1)
Evaluation of anchorage loss
Evaluation and comparison of the amount of maxillary molar mesial movement (anchorage loss) between both groups via study models assessment.
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 posted8 May 2020
- Study start15 Oct 2016
- Primary completion10 Jun 2018
- Study completion24 Feb 2019
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.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Buccal \&palatal LLLT Group, Buccal \&palatal LLLT Group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Mohammed Yahya Al-Haj, Al-Azhar University
- Investigators
- Abdullah M Al-Haj, MSc student, Principal investigator, Al-Azhar UniversityFarouk A Hussein, Ass.Prof, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381442
- Sponsor's protocol ID
- Laser Effect Canine Movement
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 8 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequence of Two Protocols and Energy Doses of Low Level Laser Therapy on the Rate of Orthodontic Canine Retraction: A Prospective Clinical Evaluation
- ClinicalTrials.gov ID
- NCT04381442
- Acronym / sponsor ID
- Laser Effect Canine Movement
- Conditions
- Dental Malocclusion
- Keywords
- Low Level Laser Therapy, Orthodontic Tooth movement, Canine Retraction, Two Protocols and Energy Doses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 24 Feb 2019 (actual)
- First posted
- 8 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.
The aim of this study was to determine whether orthodontically moved maxillary canines exposed to two different protocols and dosage of LLLT exhibited differences in amount and rate of orthodontic tooth movement.
Detailed description
Fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years were included. They had a clinical indication for bilateral extraction of at least first maxillary premolars. Using a split mouth design, maxillary left and right sides were randomly divided into two groups. In group 1, LLLT was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. In group II, laser was applied from buccal side only at 5 points through the same order with a dose of 4 J per session. In both protocols, maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point. Both sides were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring. In both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. Amount and monthly rate of maxillary canine retraction and degree of anchorage loss were determined by direct intraoral and indirect 3D digital models measurements. Evaluations were undertaken immediately before initiating retraction (T0), after 4 weeks (T1), after 8 weeks (T2), after 12 weeks (T3), after 16 weeks (T4), after 20 weeks (T5), and after 24 weeks (T6). Significance level was set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Buccal \&palatal LLLT Group, Buccal \&palatal LLLT Group
| Arm | Type | Receives |
|---|---|---|
| Buccal &palatal low level laser therapy | Experimental | Radiation: Low Level Laser TherapyIn group I,low level laser therapy was delivered at 10 points; 5 from buccal and 5 from palatal aspects with a total dose of 8 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. |
| Buccal low level laser therapy | Active comparator | Radiation: Low Level Laser TherapyIn group II, low level laser therapy was delivered at 5 points; from buccal palatal aspects only with a total dose of 4 Joule (J) per session that distributed as follows; 2 cervical, 1 middle, 2 apical. Maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point.Maxillary canines were distalized by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil spring.Laser regimen was applied on days 0, 3, 7, and 14 in the 1st month, and thereafter on every 15th day until 6-month observation period of canine retraction phase. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Complete permanent dentition (3rd molars excluded).
- The age was ranged from 15 -25 years.
- Malocclusion that required extraction of at least maxillary first premolars, followed by canine retraction.
- Good oral hygiene and periodontal health.
Key exclusion criteria (5 listed)
- Patients who diagnosed to have an indication for non-extraction approach.
- Serious systemic diseases and/or long term medications that could interfere with OTM.
- Previous orthodontic treatment.
- Poor oral hygiene or periodontally compromised patients.
- Craniofacial anomalies or history of parafunctional habits.
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: Photobiomodulation | Radiation | Buccal &palatal low level laser therapy, Buccal low level laser therapy |
Primary outcome
Evaluation the rate of maxillary canine retraction
Time frame: 6 Months
Evaluation and comparison of amount and monthly rate of distal movement of maxillary canine, in both groups, that were determined by direct intraoral measurements and indirect measurements of 3D scanned study models
1 secondary outcome
Evaluation of anchorage loss
Time frame: 6 Months
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 8 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.
Abdullah M Al-Haj, MSc student principal investigator
Al-Azhar University
Farouk A Hussein, Ass.Prof study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Dental Malocclusion, run by Al-Azhar University.
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 4 inclusion and 5 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 the rate of maxillary canine retraction (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 8 May 2020.