Low Level Laser TherapyNCT05550168
Effect of Low-level Laser Therapy on Orthodontic Tooth Movement
A study testing Low Level Laser therapy in people with Low Level Laser Therapy, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
The objective of this trial is to investigate the effect of low-level laser therapy (LLLT) on orthodontic tooth movement during maxillary molar distalization over 12-week observation period. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Level Laser Therapy
- What is being tested?
- Low Level Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCyprus
- Study dates
- 29 Jan 2021to 14 Jan 2022
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Skeletal class I or mild class II malocclusion,
- No untreated decayed teeth,
- Normodivergent skeletal pattern,
- Fully erupted maxillary first and second molars,
- Male and female individuals between the ages of 16 and 22,
- Extracted or congenitally missing maxillary third molars,
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- Non smoker,
- No alveolar bone loss or periodontal disease,
- Bilateral class II molar relationship,
- Absence of crowding or spacing in the posterior region,
- Adequate oral hygiene.
- No drug usage that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS)
Who cannot join
- • Hypodivergent or hyperdivergent skeletal pattern,
- Alveolar bone loss or periodontal disease,
- Systemic illnesses that might affect bone metabolism,
- Any drug use that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS),
- Inadequate oral hygiene,
- Unilateral class II molar relationship,
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- Smoker,
- Severe class II skeletal malocclusion (ANB>7°),
- Crowding or spacing in the posterior region,
- Missing maxillary second molars,
- Existence of maxillary third molars,
- Having untreated decayed teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-level Laser Therapy on Orthodontic Tooth Movement During Miniscrew-supported Maxillary Molar Distalization in Humans: A Single-blind, Randomized Controlled Clinical Trial
The objective of this trial is to investigate the effect of low-level laser therapy (LLLT) on orthodontic tooth movement during maxillary molar distalization over 12-week observation period.
Read the detailed description
The duration of orthodontic treatment may be prolonged depending on many factors such as the ratio of bone remodeling, the tooth anchorage, the type of applied mechanics, patient cooperation, and the necessity of keeping the applied forces during the treatment within physiological limits.1-7 Prolonged treatment might affect the psychosocial status of the patient and might lead to a decrease in the level of patient cooperation, and increase the risk of developing a pathological incident such as dental caries, periodontal diseases, alveolar bone resorption and root resorption due to insufficient oral hygiene.8-10 Increasing the intensity of the applied force in an attempt to accelerate tooth movement will cause closure of the blood vessels, and necrosis in the periodontal ligament, and will lead to inhibition of any cellular activity, which is also known as hyalinization.3-7 Various approaches such as local-systemic drug administration, mechanical-physical stimulations, and surgically-assisted approaches aimed at reducing the resistance of periodontal tissues against tooth movement and the effect of changing environmental factors have been developed to accelerate tooth movement and shorten the treatment period without increasing the intensity of the orthodontic force.2 LLLT (low-level laser therapy ) is one of the methods used for tooth movement therapy. Due to its non-invasive nature, safety, accessibility and bio-stimulating effects, LLLT is considered to be a promising tool for the future of dentistry.10 LLLT is currently being used to help speed up the ratio of bone formation in the suture after rapid maxillary expansion,18 reduce pain after orthodontic activation,19-21 and accelerate tooth movement19-32 in orthodontic clinical practices. In the literature, many of the experimental and clinical studies conducted to accelerate tooth movement by using the bio-stimulating effect of laser have demonstrated that tooth movement can be accelerated with LLLT.20-26 When compared with the previously mentioned approaches, no study has yet been found reporting any negative systemic effects of LLLT so far. It has been stated that there is a need for clinical trials to investigate the effects of non-invasive approaches that have the potential to accelerate tooth movement in different dentoalveolar regions.33 In this context, no previous study examined the effects of LLLT on maxillary molar distalization using a miniscrew-supported intraoral appliance. The aim of this study is to examine the contribution and effects of LLLT on orthodontic tooth movement during maxillary molar distalization using a miniscrew-supported intraoral appliance when compared with the control group.
- Conditions
- Low Level Laser Therapy
- Being tested
- Low Level Laser therapy
- Keywords
- Accelerated orthodontic tooth movement, Biostimulation, Molar distalization, Humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser therapyDevice
The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Laser group) | Experimental | The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period. Receives: Device: Low Level Laser therapy |
| Contralateral (Non-laser group) | No intervention | Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement |
| Control (Non-laser group) | No intervention | Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of maxillary molar distalization
Measurements were made using miniscrew as a reference point. Digital measurements were made on Geomagic Studio 2014 software to evaluate the amount of maxillary molar distalization. All 3D digital model measurements were coded, and the same researcher carried out two separate measurements 1-week apart to increase the reliability of the measurements. Parallelism was ensured between the dental arch and the Y-axis on the side where the measurements would be made by guiding the models. The parallelism of the dental arch to the Y-axis was also assessed from the lateral view. The midpoint of the first miniscrew and the mesial edge of the maxillary first molar were marked in the occlusal view. Then the distance between the projections of these two reference points to the Y-axis was measured. The difference between the two consecutive measurements indicated the 3-week amount of distalization in T1, T2, T3 and T4. This procedure was applied on both sides of all 3D models
Measured: 84 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start29 Jan 2021
- Primary completion1 Sep 2021
- Study completion14 Jan 2022
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical trial with experimental and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beren Özsoy, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550168
- Sponsor's protocol ID
- NearEastU-001
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozsoy B, Gulduren K, Kamiloglu B. Effect of low-level laser therapy on orthodontic tooth movement during miniscrew-supported maxillary molar distalization in humans: a single-blind, randomized controlled clinical trial. Lasers Med Sci. 2023 Feb 20;38(1):76. doi: 10.1007/s10103-023-03736-y.
PubMed 36807215
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy on Orthodontic Tooth Movement During Miniscrew-supported Maxillary Molar Distalization in Humans: A Single-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05550168
- Acronym / sponsor ID
- NearEastU-001
- Conditions
- Low Level Laser Therapy
- Keywords
- Accelerated orthodontic tooth movement, Biostimulation, Molar distalization, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 22 Sep 2022 (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 objective of this trial is to investigate the effect of low-level laser therapy (LLLT) on orthodontic tooth movement during maxillary molar distalization over 12-week observation period.
Detailed description
The duration of orthodontic treatment may be prolonged depending on many factors such as the ratio of bone remodeling, the tooth anchorage, the type of applied mechanics, patient cooperation, and the necessity of keeping the applied forces during the treatment within physiological limits.1-7 Prolonged treatment might affect the psychosocial status of the patient and might lead to a decrease in the level of patient cooperation, and increase the risk of developing a pathological incident such as dental caries, periodontal diseases, alveolar bone resorption and root resorption due to insufficient oral hygiene.8-10 Increasing the intensity of the applied force in an attempt to accelerate tooth movement will cause closure of the blood vessels, and necrosis in the periodontal ligament, and will lead to inhibition of any cellular activity, which is also known as hyalinization.3-7 Various approaches such as local-systemic drug administration, mechanical-physical stimulations, and surgically-assisted approaches aimed at reducing the resistance of periodontal tissues against tooth movement and the effect of changing environmental factors have been developed to accelerate tooth movement and shorten the treatment period without increasing the intensity of the orthodontic force.2 LLLT (low-level laser therapy ) is one of the methods used for tooth movement therapy. Due to its non-invasive nature, safety, accessibility and bio-stimulating effects, LLLT is considered to be a promising tool for the future of dentistry.10 LLLT is currently being used to help speed up the ratio of bone formation in the suture after rapid maxillary expansion,18 reduce pain after orthodontic activation,19-21 and accelerate tooth movement19-32 in orthodontic clinical practices. In the literature, many of the experimental and clinical studies conducted to accelerate tooth movement by using the bio-stimulating effect of laser have demonstrated that tooth movement can be accelerated with LLLT.20-26 When compared with the previously mentioned approaches, no study has yet been found reporting any negative systemic effects of LLLT so far. It has been stated that there is a need for clinical trials to investigate the effects of non-invasive approaches that have the potential to accelerate tooth movement in different dentoalveolar regions.33 In this context, no previous study examined the effects of LLLT on maxillary molar distalization using a miniscrew-supported intraoral appliance. The aim of this study is to examine the contribution and effects of LLLT on orthodontic tooth movement during maxillary molar distalization using a miniscrew-supported intraoral appliance when compared with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A clinical trial with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Intervention (Laser group) | Experimental | Device: Low Level Laser therapyThe participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period. |
| Contralateral (Non-laser group) | No intervention | –Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement |
| Control (Non-laser group) | No intervention | –Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Skeletal class I or mild class II malocclusion,
Key exclusion criteria (12 listed)
- • Hypodivergent or hyperdivergent skeletal pattern,
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 participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period. | Device | Intervention (Laser group) |
Primary outcome
Amount of maxillary molar distalization
Time frame: 84 days after
Measurements were made using miniscrew as a reference point. Digital measurements were made on Geomagic Studio 2014 software to evaluate the amount of maxillary molar distalization. All 3D digital model measurements were coded, and the same researcher carried out two separate measurements 1-week apart to increase the reliability of the measurements. Parallelism was ensured between the dental arch and the Y-axis on the side where the measurements would be made by guiding the models. The parallelism of the dental arch to the Y-axis was also assessed from the lateral view. The midpoint of the first miniscrew and the mesial edge of the maxillary first molar were marked in the occlusal view. Then the distance between the projections of these two reference points to the Y-axis was measured. The difference between the two consecutive measurements indicated the 3-week amount of distalization in T1, T2, T3 and T4. This procedure was applied on both sides of all 3D models
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 22 Sep 2022.
- Derived from this study: PubMed 36807215Ozsoy B, Gulduren K, Kamiloglu B. Effect of low-level laser therapy on orthodontic tooth movement during miniscrew-supported maxillary molar distalization in humans: a single-blind, randomized controlled clinical trial. Lasers Med Sci. 2023 Feb 20;38(1):76. doi: 10.1007/s10103-023-03736-y.
- Individual participant dataSharing planned: No
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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.
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 Low Level Laser therapy in people with Low Level Laser Therapy, run by Near East University, Turkey at 1 site in Cyprus.
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 12 inclusion and 12 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 22 Sep 2022. 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 Cyprus. 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?
Amount of maxillary molar distalization (time frame: 84 days after). 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 NCT05550168, 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 22 Sep 2022.