Low Level Laser TherapyNCT05469451
Effect of the Diode Laser (940nm) on Orthodontics
A study testing Low level laser therapy in people with Low Level Laser Therapy and Pain, run by Fundación Universitaria CIEO at 1 site in Colombia.
Trial summary
To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Level Laser Therapy, Pain, Crowding, Tooth
- What is being tested?
- Low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 20 Aug 2022to 20 Dec 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages between 20 and 40 years
- Male or female
- All lower permanent teeth or at least 36 to 46
- Little's irregularity index 3mm to 6mm
- Without prior orthodontic treatment
- Periodontally stable
- Non-smokers
- Voluntarily agreed to participate in the study by signing the informed consent
Who cannot join
- Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements
- Systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism)
- Pregnant women
- Infants
- Patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Universitaria UniCIEO
Bogotá, 110111
Alexandra Perez, +573214516767, a.perez@unicieo.edu.co
About this study
Official title: Effect of Diode Laser (940nm) on Total Relief of Dental Crowding and Pain Perception in Orthodontics: Randomized Clinical Trial (RCT)
To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
Read the detailed description
Objectives: To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
Design: Randomized clinical trial. Setting: orthodontic treatment from the Orthodontic postgraduate course at the CIEO University (CIEO), located in the city of Bogotá, Colombia Participants: 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent. Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements, with systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism) were excluded. , pregnant women, infants and patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
Intervention: group 1 irradiated with low power laser (940nm) and. Group 2: it was simulated that they were irradiated. The therapeutic laser was applied for a time of 10 seconds on the buccal surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at the gingival level and at the apical level in scanning mode, on the day of cementation of the appliance and subsequently every fifteen days for 3 months.
Main outcome measures: total relief of dental crowding measured through the little index in digital models and pain perception through the visual analog scale.
Randomization: Four patients were randomized with the randomized blocks technique.
Blinding (masking): The patients participating in the clinical trial, the statistician, the students and the study operators who are going to measure Little's irregularity index will be blinded to the interventions, except the principal investigator.
- Conditions
- Low Level Laser Therapy, Pain, Crowding, Tooth
- Being tested
- Low level laser therapy
- Keywords
- Low-Level Light Therapy, Malocclusion, Orthodontics, Pain
- Medical subject headings
- Pain, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyProcedure or surgery
Irradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: irradiated with low power laser (940nm) | Experimental | Irradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode. Receives: Procedure: Low level laser therapy |
| Group 2: Simulated that they were irradiated. | Placebo comparator | Group 2: it was simulated that they were irradiated. Receives: Procedure: Low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total relief of dental crowding
This was measured as the resolution of anterior crowding in the lower arch calculated by the difference of Little's irregularity index, the distance in millimeters between the contact points from mesial of the canine to mesial of the contralateral canine in the lower arch in the digitized models in each of the established times. Perfect alignment from the mesial aspect of the left canine to the mesial aspect of the right canine would theoretically have a score of 0, with greater crowding represented by greater displacement and thus a higher index score.
Measured: 3 months
Secondary outcomes (1)
Pain perception
by means of the visual analog scale that represents the intensity of the pain in a line from 0 to 10. At one end there is the phrase "no pain" and at the opposite end "the worst pain imaginable". A value of less than 4 on the VAS means mild or mild-moderate pain, a value between 4 and 6 implies the presence of moderate-severe pain, and a value greater than 6 implies the presence of very intense pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start20 Aug 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria CIEO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana M Montoya, MSc, Study chair, Fundación Universitaria CIEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469451
- Sponsor's protocol ID
- UniCIEOLaser01
- Status last verified
- Aug 2022
- First submitted
- 18 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gounder R, Gounder S. Laser Science and its Applications in Prosthetic Rehabilitation. J Lasers Med Sci. 2016 Fall;7(4):209-213. doi: 10.15171/jlms.2016.37. Epub 2016 Oct 27.
PubMed 28491254Demirsoy KK, Kurt G. Use of Laser Systems in Orthodontics. Turk J Orthod. 2020 May 22;33(2):133-140. doi: 10.5152/TurkJOrthod.2020.18099. eCollection 2020 Jun.
PubMed 32637195Chen H, Han B, Jiang R, Su H, Feng T, Teng F, Xu T. PASS versus MBT for evaluation of anchorage control in three-dimensional measurements: a randomized controlled trial. Eur J Orthod. 2021 Jan 29;43(1):113-119. doi: 10.1093/ejo/cjaa021.
PubMed 32255178Scott P, Sherriff M, Dibiase AT, Cobourne MT. Perception of discomfort during initial orthodontic tooth alignment using a self-ligating or conventional bracket system: a randomized clinical trial. Eur J Orthod. 2008 Jun;30(3):227-32. doi: 10.1093/ejo/cjm131. Epub 2008 Mar 13.
PubMed 18339656Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
PubMed 1059332MOORREES CF, REED RB. Biometrics of crowding and spacing of the teeth in the mandible. Am J Phys Anthropol. 1954 Mar;12(1):77-88. doi: 10.1002/ajpa.1330120120. No abstract available.
PubMed 13148326Shaughnessy T, Kantarci A, Kau CH, Skrenes D, Skrenes S, Ma D. Intraoral photobiomodulation-induced orthodontic tooth alignment: a preliminary study. BMC Oral Health. 2016 Jan 13;16:3. doi: 10.1186/s12903-015-0159-7.
PubMed 26762247Proffit WR, Ackerman JL. Rating the characteristics of malocclusion: a systematic approach for planning treatment. Am J Orthod. 1973 Sep;64(3):258-69. doi: 10.1016/0002-9416(73)90019-5. No abstract available.
PubMed 4579697Camacho AD, Velasquez Cujar SA. Dental movement acceleration: Literature review by an alternative scientific evidence method. World J Methodol. 2014 Sep 26;4(3):151-62. doi: 10.5662/wjm.v4.i3.151. eCollection 2014 Sep 26.
PubMed 25332914Peck H, Peck S. An index for assessing tooth shape deviations as applied to the mandibular incisors. Am J Orthod. 1972 Apr;61(4):384-401. doi: 10.1016/0002-9416(72)90302-8. No abstract available.
PubMed 4501985Li B, Zhao ZH. [Adjunctive interventions to accelerate orthodontic tooth movement]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2019 Dec 1;37(6):648-655. doi: 10.7518/hxkq.2019.06.014. Chinese.
PubMed 31875445Diddige R, Negi G, Kiran KVS, Chitra P. Comparison of pain levels in patients treated with 3 different orthodontic appliances - a randomized trial. Med Pharm Rep. 2020 Jan;93(1):81-88. doi: 10.15386/mpr-1311. Epub 2020 Jan 31.
PubMed 32133451Asiry MA. Biological aspects of orthodontic tooth movement: A review of literature. Saudi J Biol Sci. 2018 Sep;25(6):1027-1032. doi: 10.1016/j.sjbs.2018.03.008. Epub 2018 Mar 14.
PubMed 30174498Fernandes LM, Ogaard B, Skoglund L. Pain and discomfort experienced after placement of a conventional or a superelastic NiTi aligning archwire. A randomized clinical trial. J Orofac Orthop. 1998;59(6):331-9. doi: 10.1007/BF01299769. English, German.
PubMed 9857602Long H, Wang Y, Jian F, Liao LN, Yang X, Lai WL. Current advances in orthodontic pain. Int J Oral Sci. 2016 Jun 30;8(2):67-75. doi: 10.1038/ijos.2016.24.
PubMed 27341389
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diode Laser (940nm) on Total Relief of Dental Crowding and Pain Perception in Orthodontics: Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT05469451
- Acronym / sponsor ID
- UniCIEOLaser01
- Conditions
- Low Level Laser Therapy, Pain, Crowding, Tooth
- Keywords
- Low-Level Light Therapy, Malocclusion, Orthodontics, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundación Universitaria CIEOUniversity, hospital or other
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 21 Jul 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.
To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
Detailed description
Objectives: To evaluate the effect of the low power density 940nm diode laser in the total relief of dental crowding during the alignment phase and the perception of pain in patients who initiate orthodontic treatment.
Design: Randomized clinical trial. Setting: orthodontic treatment from the Orthodontic postgraduate course at the CIEO University (CIEO), located in the city of Bogotá, Colombia Participants: 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent. Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements, with systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism) were excluded. , pregnant women, infants and patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
Intervention: group 1 irradiated with low power laser (940nm) and. Group 2: it was simulated that they were irradiated. The therapeutic laser was applied for a time of 10 seconds on the buccal surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at the gingival level and at the apical level in scanning mode, on the day of cementation of the appliance and subsequently every fifteen days for 3 months.
Main outcome measures: total relief of dental crowding measured through the little index in digital models and pain perception through the visual analog scale.
Randomization: Four patients were randomized with the randomized blocks technique.
Blinding (masking): The patients participating in the clinical trial, the statistician, the students and the study operators who are going to measure Little's irregularity index will be blinded to the interventions, except the principal investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 50 randomized subjects, 25 per group, seen during the alignment phase with ages between 20 and 40 years, male or female, with all lower permanent teeth or at least 36 to 46, with Little's irregularity index 3mm to 6mm, without prior orthodontic treatment, periodontally stable, non-smokers and who voluntarily agreed to participate in the study by signing the informed consent.
| Arm | Type | Receives |
|---|---|---|
| Group 1: irradiated with low power laser (940nm) | Experimental | Procedure: Low level laser therapyIrradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode. |
| Group 2: Simulated that they were irradiated. | Placebo comparator | Procedure: Low level laser therapyGroup 2: it was simulated that they were irradiated. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ages between 20 and 40 years
- Male or female
- All lower permanent teeth or at least 36 to 46
- Little's irregularity index 3mm to 6mm
- Without prior orthodontic treatment
Key exclusion criteria (5 listed)
- Patients with a history of long-term medications that interfere with bone metabolism and / or pain synthesis (bisphosphonates, anti-inflammatory or analgesic drugs and hormonal supplements
- Systemic diseases (Diabetes, hyperthyroidism, disease with bone metabolism)
- Pregnant women
- Infants
- Patients who, during the alignment phase, require the implementation of metal ligatures, springs to expand spaces and lace back uses in the technique.
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 therapyIrradiated with a low power density laser of 940 (nm), 100 megawatt, which will be calibrated and the result of the calibration will be checked with the use of the power meter. The equipment used will be a diode laser (BIOLASE™), the area to be irradiated will be the anterior segment of the lower arch, each tooth will be irradiated for a time of 10 seconds on the vestibular surfaces of the teeth and 10 seconds on the lingual surfaces of the teeth, both at gingival level and at apical level in scanning mode. | Procedure or surgery | Group 1: irradiated with low power laser (940nm), Group 2: Simulated that they were irradiated. |
Primary outcome
Total relief of dental crowding
Time frame: 3 months
This was measured as the resolution of anterior crowding in the lower arch calculated by the difference of Little's irregularity index, the distance in millimeters between the contact points from mesial of the canine to mesial of the contralateral canine in the lower arch in the digitized models in each of the established times. Perfect alignment from the mesial aspect of the left canine to the mesial aspect of the right canine would theoretically have a score of 0, with greater crowding represented by greater displacement and thus a higher index score.
1 secondary outcome
Pain perception
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 28491254Gounder R, Gounder S. Laser Science and its Applications in Prosthetic Rehabilitation. J Lasers Med Sci. 2016 Fall;7(4):209-213. doi: 10.15171/jlms.2016.37. Epub 2016 Oct 27.
- Background: PubMed 32637195Demirsoy KK, Kurt G. Use of Laser Systems in Orthodontics. Turk J Orthod. 2020 May 22;33(2):133-140. doi: 10.5152/TurkJOrthod.2020.18099. eCollection 2020 Jun.
- Background: PubMed 32255178Chen H, Han B, Jiang R, Su H, Feng T, Teng F, Xu T. PASS versus MBT for evaluation of anchorage control in three-dimensional measurements: a randomized controlled trial. Eur J Orthod. 2021 Jan 29;43(1):113-119. doi: 10.1093/ejo/cjaa021.
- Background: PubMed 18339656Scott P, Sherriff M, Dibiase AT, Cobourne MT. Perception of discomfort during initial orthodontic tooth alignment using a self-ligating or conventional bracket system: a randomized clinical trial. Eur J Orthod. 2008 Jun;30(3):227-32. doi: 10.1093/ejo/cjm131. Epub 2008 Mar 13.
- Background: PubMed 1059332Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
- Background: PubMed 13148326MOORREES CF, REED RB. Biometrics of crowding and spacing of the teeth in the mandible. Am J Phys Anthropol. 1954 Mar;12(1):77-88. doi: 10.1002/ajpa.1330120120. No abstract available.
- Background: PubMed 26762247Shaughnessy T, Kantarci A, Kau CH, Skrenes D, Skrenes S, Ma D. Intraoral photobiomodulation-induced orthodontic tooth alignment: a preliminary study. BMC Oral Health. 2016 Jan 13;16:3. doi: 10.1186/s12903-015-0159-7.
- Background: PubMed 4579697Proffit WR, Ackerman JL. Rating the characteristics of malocclusion: a systematic approach for planning treatment. Am J Orthod. 1973 Sep;64(3):258-69. doi: 10.1016/0002-9416(73)90019-5. No abstract available.
- Background: PubMed 25332914Camacho AD, Velasquez Cujar SA. Dental movement acceleration: Literature review by an alternative scientific evidence method. World J Methodol. 2014 Sep 26;4(3):151-62. doi: 10.5662/wjm.v4.i3.151. eCollection 2014 Sep 26.
- Background: PubMed 4501985Peck H, Peck S. An index for assessing tooth shape deviations as applied to the mandibular incisors. Am J Orthod. 1972 Apr;61(4):384-401. doi: 10.1016/0002-9416(72)90302-8. No abstract available.
- Background: PubMed 31875445Li B, Zhao ZH. [Adjunctive interventions to accelerate orthodontic tooth movement]. Hua Xi Kou Qiang Yi Xue Za Zhi. 2019 Dec 1;37(6):648-655. doi: 10.7518/hxkq.2019.06.014. Chinese.
- Background: PubMed 32133451Diddige R, Negi G, Kiran KVS, Chitra P. Comparison of pain levels in patients treated with 3 different orthodontic appliances - a randomized trial. Med Pharm Rep. 2020 Jan;93(1):81-88. doi: 10.15386/mpr-1311. Epub 2020 Jan 31.
- 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.
Diana M Montoya, MSc study chair
Fundación Universitaria CIEO
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 and Pain, 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 8 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: status not confirmed, as of the sponsor's last update on 4 Aug 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 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 Diana M Montoya, MSc (3164469500, dm.montoya@unicieo.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total relief of dental crowding (time frame: 3 months). 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 NCT05469451, which also lists 28 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 4 Aug 2022.