MalocclusionNCT04628390
Laser Therapy on Controlling Pain During Orthondontic Treatment
A study testing Laser in people with Malocclusion, run by Fundación Universitaria CIEO at 1 site in Colombia.
Trial summary
To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 20 Nov 2020to 20 Feb 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
- No need extractions
- No need Stripping
Who cannot join
- Periodontal disease
- Pregnant or lactance
- Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- Cardiac markpaser
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación universitaria CIEO - UniCIEO
Bogotá, 11001
Jaime E. Donado, DDS, 3208388047, jaimedonadom@yahoo.com
About this study
Official title: Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment
To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.
Read the detailed description
This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia.
Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial.
This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out.
Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours).
After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments.
The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.
- Conditions
- Malocclusion
- Being tested
- Laser, Placebo
- Keywords
- Laser, orthodontic, TIP EDGE
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Also called LLLT
The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
PlaceboOther
Also called Simulation laser
Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth. Receives: Device: Laser |
| Placebo | Placebo comparator | A simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the "Change in Orthodontic Pain Levels"
The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS)
Measured: Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
Secondary outcomes (1)
Need for analgesic
Frequency and Need after the treatment
Measured: Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start20 Nov 2020 (estimated)
- Primary completion20 Jan 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Enrique Donado Manotas, Fundación Universitaria CIEO
- Investigators
- Jaime E. Donado, DDS, Principal investigator, Fundación universitaria CIEO-UniCIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628390
- Sponsor's protocol ID
- UniCIEO-laser001
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ordahan B, Karahan AY, Kaydok E. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial. Lasers Med Sci. 2018 Aug;33(6):1363-1369. doi: 10.1007/s10103-018-2497-6. Epub 2018 Apr 7.
PubMed 29627888Genc 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 22350425Sommer AP, Schemmer P, Pavlath AE, Forsterling HD, Mester AR, Trelles MA. Quantum biology in low level light therapy: death of a dogma. Ann Transl Med. 2020 Apr;8(7):440. doi: 10.21037/atm.2020.03.159.
PubMed 32395484Basso FG, Pansani TN, Turrioni AP, Bagnato VS, Hebling J, de Souza Costa CA. In vitro wound healing improvement by low-level laser therapy application in cultured gingival fibroblasts. Int J Dent. 2012;2012:719452. doi: 10.1155/2012/719452. Epub 2012 Jul 15.
PubMed 22844284Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.
PubMed 12355572Timberlake GT, Enwemeka CS. An inexpensive, automated instrument for laser irradiation of cultured cells. Photomed Laser Surg. 2004 Jun;22(3):233-9. doi: 10.1089/1549541041438614.
PubMed 15315731Lirani-Galvao AP, Jorgetti V, da Silva OL. Comparative study of how low-level laser therapy and low-intensity pulsed ultrasound affect bone repair in rats. Photomed Laser Surg. 2006 Dec;24(6):735-40. doi: 10.1089/pho.2006.24.735.
PubMed 17199474Tecco S, D'Attilio M, Tete S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22.
PubMed 19465738Sousa MV, Pinzan A, Consolaro A, Henriques JF, de Freitas MR. Systematic literature review: influence of low-level laser on orthodontic movement and pain control in humans. Photomed Laser Surg. 2014 Nov;32(11):592-9. doi: 10.1089/pho.2014.3789. Epub 2014 Oct 21.
PubMed 25335088Seifi M, Shafeei HA, Daneshdoost S, Mir M. Effects of two types of low-level laser wave lengths (850 and 630 nm) on the orthodontic tooth movements in rabbits. Lasers Med Sci. 2007 Nov;22(4):261-4. doi: 10.1007/s10103-007-0447-9. Epub 2007 Mar 3.
PubMed 17334676
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level 810nm Laser Therapy on Controlling Pain During a First Stage of Orthondontic Treatment
- ClinicalTrials.gov ID
- NCT04628390
- Acronym / sponsor ID
- UniCIEO-laser001
- Conditions
- Malocclusion
- Keywords
- Laser, orthodontic, TIP EDGE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 20 Nov 2020 (estimated)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 13 Nov 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 effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.
Detailed description
This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia.
Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial.
This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out.
Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours).
After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments.
The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial. Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours)
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: LaserThe low-power therapeutic diode laser will be applied with a wavelength 810nm ± 15nm, output power 0-2 W CW / 0-4.8 W peak power (pulse mode), for a time of 20 seconds per centimeter at lo along the buccal surface of the root of the upper and lower teeth. |
| Placebo | Placebo comparator | Other: PlaceboA simulation of the application of therapeutic laser will be carried out as a placebo effect, for a time of 20 seconds per centimeter along the vestibular surface of the root of the upper and lower teeth. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
- No need extractions
- No need Stripping
Key exclusion criteria (4 listed)
- Periodontal disease
- Pregnant or lactance
- Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- Cardiac markpaser
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 |
|---|---|---|
| LaserAlso: LLLTThe laser application will be carried out only once, immediately after the cementation of the orthodontic appliance. | Device | Experimental |
| PlaceboAlso: Simulation laserSimulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance. | Other | Placebo |
Primary outcome
Measure the "Change in Orthodontic Pain Levels"
Time frame: Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
The evaluation of the difference in pain levels will be determined as a percentage of change and difference in means of pain levels. The difference and the percentage will be calculated by comparing the baseline pain levels observed between the different follow-up times. A rule of three is applied to determine the percentage of change (%) and a subtraction of the pain averages to calculate the difference. Pain analysis will be performed using the visual analog scale (VAS)
1 secondary outcome
Need for analgesic
Time frame: Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 29627888Ordahan B, Karahan AY, Kaydok E. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: a randomized clinical trial. Lasers Med Sci. 2018 Aug;33(6):1363-1369. doi: 10.1007/s10103-018-2497-6. Epub 2018 Apr 7.
- 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 32395484Sommer AP, Schemmer P, Pavlath AE, Forsterling HD, Mester AR, Trelles MA. Quantum biology in low level light therapy: death of a dogma. Ann Transl Med. 2020 Apr;8(7):440. doi: 10.21037/atm.2020.03.159.
- Background: PubMed 22844284Basso FG, Pansani TN, Turrioni AP, Bagnato VS, Hebling J, de Souza Costa CA. In vitro wound healing improvement by low-level laser therapy application in cultured gingival fibroblasts. Int J Dent. 2012;2012:719452. doi: 10.1155/2012/719452. Epub 2012 Jul 15.
- Background: PubMed 12355572Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7. doi: 10.1002/lsm.10107.
- Background: PubMed 15315731Timberlake GT, Enwemeka CS. An inexpensive, automated instrument for laser irradiation of cultured cells. Photomed Laser Surg. 2004 Jun;22(3):233-9. doi: 10.1089/1549541041438614.
- Background: PubMed 17199474Lirani-Galvao AP, Jorgetti V, da Silva OL. Comparative study of how low-level laser therapy and low-intensity pulsed ultrasound affect bone repair in rats. Photomed Laser Surg. 2006 Dec;24(6):735-40. doi: 10.1089/pho.2006.24.735.
- Background: PubMed 19465738Tecco S, D'Attilio M, Tete S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22.
- Background: PubMed 25335088Sousa MV, Pinzan A, Consolaro A, Henriques JF, de Freitas MR. Systematic literature review: influence of low-level laser on orthodontic movement and pain control in humans. Photomed Laser Surg. 2014 Nov;32(11):592-9. doi: 10.1089/pho.2014.3789. Epub 2014 Oct 21.
- Background: PubMed 17334676Seifi M, Shafeei HA, Daneshdoost S, Mir M. Effects of two types of low-level laser wave lengths (850 and 630 nm) on the orthodontic tooth movements in rabbits. Lasers Med Sci. 2007 Nov;22(4):261-4. doi: 10.1007/s10103-007-0447-9. Epub 2007 Mar 3.
- 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.
Jaime E. Donado, DDS principal investigator
Fundación universitaria CIEO-UniCIEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser in people with Malocclusion, run by Fundación Universitaria CIEO at 1 site in Colombia.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Nov 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime E. Donado, DDS (3208388047, jaimedonadom@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the "Change in Orthodontic Pain Levels" (time frame: Baseline (before treatment), 12 hours (after the start of treatment), 24 hours (after the start of treatment) 48 hours (after the start of treatment) 72 hours(after the start of treatment)). 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 NCT04628390, which also lists 10 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 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.