Laser TherapyNCT04070170
Laser Therapy on Orthodontic Tooth Movement
A study testing Low-level Laser Therapy and Orthodontic force in people with Laser Therapy and Orthodontic Tooth Movement, run by Ildeu Andrade Jr. at 1 site in Brazil.
Trial summary
The aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1) enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser Therapy, Orthodontic Tooth Movement, Bone Remodeling
- What is being tested?
- Low-level Laser Therapy and Orthodontic force
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2014to 16 Sep 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Facial convexity
- Protrusion or biprotrusion of the incisors
- Dental crowding
- Healthy periodontal condition
- Satisfactory oral hygiene
Who cannot join
- Patients under medications that may interfere with bone metabolism, such as anti-inflammatory, antibiotics and hormonal supplements in the previous three months
- Skeletal crossbite
- Parafunctional habits
- Occlusal interference
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifical Catholic University of Minas Gerais
Belo Horizonte, Minas Gerais, 30535-901
About this study
Official title: The Effects of Lower Level Laser Therapy on Orthodontic Tooth Movement
The aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1) enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects.
- Conditions
- Laser Therapy, Orthodontic Tooth Movement, Bone Remodeling
- Being tested
- Low-level Laser Therapy, Orthodontic force
- Keywords
- Low-Level Light Therapy, Tooth Movement, Bone Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Laser TherapyDevice
Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons
Orthodontic forceProcedure or surgery
Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
| Study group | Role | What they receive |
|---|---|---|
| Low-level laser therapy and no orthodontic force | Experimental | No orthodontic force. Laser is applied on the first day and the premolars is extracted after 24 hours Receives: Device: Low-level Laser Therapy |
| Low-level laser therapy and application of orthodontic force | Experimental | Orthodontic force and Laser is applied on the first day and the premolars is extracted after 24 hours Receives: Device: Low-level Laser Therapy; Procedure: Orthodontic force |
| Orthodontic force only | Active comparator | Orthodontic force is applied and the premolars is extracted after 24 hours, with no laser therapy Receives: Procedure: Orthodontic force |
| Low-level laser therapy and orthodontic force | Experimental | Orthodontic force and Laser is applied and the orthodontic tooth movement is evaluated Receives: Device: Low-level Laser Therapy; Procedure: Orthodontic force |
| Orthodontic force with no laser therapy | Active comparator | Orthodontic force is applied and the orthodontic tooth movement is evaluated, with no laser therapy Receives: Procedure: Orthodontic force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of orthodontic tooth movement, with and without low-level laser therapy
The canine retraction was measured with a digital dynamometer
Measured: The quantification of OTM was performed before canine retraction
Rate of orthodontic tooth movement, with and without low-level laser therapy
The canine retraction was measured with a digital dynamometer
Measured: The quantification of OTM was performed after 1 month of canine retraction
Rate of orthodontic tooth movement, with and without low-level laser therapy
The canine retraction was measured with a digital dynamometer
Measured: The quantification of OTM was performed after 2 months of canine retraction
Rate of orthodontic tooth movement, with and without low-level laser therapy
The canine retraction was measured with a digital dynamometer
Measured: The quantification of OTM was performed after 3 months of canine retraction
Secondary outcomes (1)
Chemokine levels in the periodontal tissue after LLLT and orthodontic force
The chemokine levels were measured in the periodontal tissue after LLLT and orthodontic force by means of a cytometric bead array (CBA)
Measured: The chemokine levels were assayed on days 0, 1, 7 and 14 after application of orthodontic force and low-level laser therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Feb 2014
- Primary completion6 Nov 2018
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ildeu Andrade Jr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ildeu Andrade Jr., Pontifícia Universidade Católica de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070170
- Sponsor's protocol ID
- Laser on tooth movement
- Status last verified
- Sep 2020
- First submitted
- 15 Aug 2019
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
PubMed 22381489Alhashimi N, Frithiof L, Brudvik P, Bakhiet M. Chemokines are upregulated during orthodontic tooth movement. J Interferon Cytokine Res. 1999 Sep;19(9):1047-52. doi: 10.1089/107999099313271.
PubMed 10505748Torri S, Weber JB. Influence of low-level laser therapy on the rate of orthodontic movement: a literature review. Photomed Laser Surg. 2013 Sep;31(9):411-21. doi: 10.1089/pho.2013.3497. Epub 2013 Jul 24.
PubMed 23883115Genc G, Kocadereli I, Tasar F, Kilinc K, El S, Sarkarati B. Effect of low-level laser therapy (LLLT) on orthodontic tooth movement. Lasers Med Sci. 2013 Jan;28(1):41-7. doi: 10.1007/s10103-012-1059-6. Epub 2012 Feb 18.
PubMed 22350425Kim SJ, Moon SU, Kang SG, Park YG. Effects of low-level laser therapy after Corticision on tooth movement and paradental remodeling. Lasers Surg Med. 2009 Sep;41(7):524-33. doi: 10.1002/lsm.20792.
PubMed 19639625
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lower Level Laser Therapy on Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT04070170
- Acronym / sponsor ID
- Laser on tooth movement
- Conditions
- Laser Therapy, Orthodontic Tooth Movement, Bone Remodeling
- Keywords
- Low-Level Light Therapy, Tooth Movement, Bone Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ildeu Andrade Jr.University, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 28 Aug 2019 (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 aims of this study will be to evaluate if a Lower Level Laser Therapy (LLLT): (1) enhances the levels of important pro-inflammatory chemokines involved in the bone remodeling process; (2) increases the rate of orthodontic tooth movement (OTM) on human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-level laser therapy and no orthodontic force | Experimental | Device: Low-level Laser TherapyNo orthodontic force. Laser is applied on the first day and the premolars is extracted after 24 hours |
| Low-level laser therapy and application of orthodontic force | Experimental | Device: Low-level Laser Therapy, Procedure: Orthodontic forceOrthodontic force and Laser is applied on the first day and the premolars is extracted after 24 hours |
| Orthodontic force only | Active comparator | Procedure: Orthodontic forceOrthodontic force is applied and the premolars is extracted after 24 hours, with no laser therapy |
| Low-level laser therapy and orthodontic force | Experimental | Device: Low-level Laser Therapy, Procedure: Orthodontic forceOrthodontic force and Laser is applied and the orthodontic tooth movement is evaluated |
| Orthodontic force with no laser therapy | Active comparator | Procedure: Orthodontic forceOrthodontic force is applied and the orthodontic tooth movement is evaluated, with no laser therapy |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Facial convexity
- Protrusion or biprotrusion of the incisors
- Dental crowding
- Healthy periodontal condition
- Satisfactory oral hygiene
Key exclusion criteria (4 listed)
- Patients under medications that may interfere with bone metabolism, such as anti-inflammatory, antibiotics and hormonal supplements in the previous three months
- Skeletal crossbite
- Parafunctional habits
- Occlusal interference
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 TherapyLow-level laser therapy is applied on premolars that will be extracted for treatment plan reasons | Device | Low-level laser therapy and application of orthodontic force, Low-level laser therapy and no orthodontic force, Low-level laser therapy and orthodontic force |
| Orthodontic forceMechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement | Procedure or surgery | Low-level laser therapy and application of orthodontic force, Low-level laser therapy and orthodontic force, Orthodontic force only, Orthodontic force with no laser therapy |
Primary outcome
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time frame: The quantification of OTM was performed before canine retraction
The canine retraction was measured with a digital dynamometer
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time frame: The quantification of OTM was performed after 1 month of canine retraction
The canine retraction was measured with a digital dynamometer
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time frame: The quantification of OTM was performed after 2 months of canine retraction
The canine retraction was measured with a digital dynamometer
Rate of orthodontic tooth movement, with and without low-level laser therapy
Time frame: The quantification of OTM was performed after 3 months of canine retraction
The canine retraction was measured with a digital dynamometer
1 secondary outcome
Chemokine levels in the periodontal tissue after LLLT and orthodontic force
Time frame: The chemokine levels were assayed on days 0, 1, 7 and 14 after application of orthodontic force and low-level laser therapy
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 24 Sep 2020.
- Background: PubMed 22381489Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
- Background: PubMed 10505748Alhashimi N, Frithiof L, Brudvik P, Bakhiet M. Chemokines are upregulated during orthodontic tooth movement. J Interferon Cytokine Res. 1999 Sep;19(9):1047-52. doi: 10.1089/107999099313271.
- Background: PubMed 23883115Torri S, Weber JB. Influence of low-level laser therapy on the rate of orthodontic movement: a literature review. Photomed Laser Surg. 2013 Sep;31(9):411-21. doi: 10.1089/pho.2013.3497. Epub 2013 Jul 24.
- Background: PubMed 22350425Genc G, Kocadereli I, Tasar F, Kilinc K, El S, Sarkarati B. Effect of low-level laser therapy (LLLT) on orthodontic tooth movement. Lasers Med Sci. 2013 Jan;28(1):41-7. doi: 10.1007/s10103-012-1059-6. Epub 2012 Feb 18.
- Background: PubMed 19639625Kim SJ, Moon SU, Kang SG, Park YG. Effects of low-level laser therapy after Corticision on tooth movement and paradental remodeling. Lasers Surg Med. 2009 Sep;41(7):524-33. doi: 10.1002/lsm.20792.
- 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 and Orthodontic force in people with Laser Therapy and Orthodontic Tooth Movement, run by Ildeu Andrade Jr. at 1 site in Brazil.
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 5 inclusion and 4 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 24 Sep 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 Brazil. 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?
Rate of orthodontic tooth movement, with and without low-level laser therapy (time frame: The quantification of OTM was performed before canine retraction). The study lists 4 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 NCT04070170, which also lists 5 linked publications.
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 24 Sep 2020.