Class II CanineCINELASERNCT02181439
Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement (Protocol CINELASER)
A study testing (LLLT Low Level Laser Therapy) SiroLaser advance in people with Class II Canine and Intermaxillary Strength, run by Nantes University Hospital at 1 site in France.
Trial summary
It is a single-center, prospective clinical study of a medical device, controlled, randomized, non-stratified, double-blind (neither the patient nor the parents know which area is irradiated / practitioner who performs the measures and evaluates the class I achievement or non also ignores the irradiated area) . Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Class II Canine, Intermaxillary Strength, Elastics II
- What is being tested?
- (LLLT Low Level Laser Therapy) SiroLaser advance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2014to 18 May 2018
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- With a Class II canine complete or partial, bilateral and symmetrical
- In permanent dentition (no deciduous teeth in the arch)
- Requiring the use of intermaxillary strength (FIM) II correction dental class II during a multi fasteners orthodontic treatment
- Leveling done beforehand*
- Anchor of the mandible is maximum
- The same technique employed should be segmented in the maxilla, in all patients (lateral sectional canine to molar).
Who cannot join
- Patient :
- having a mental deficiency or child who can not read or write (difficulties in completing the questionnaire )
- with lack of cooperation (withdrawal, refuse to wear FIM II)
- who missed at least 3 consecutive appointments according to the medical record ,
- with orofacial malignant tumor
- having unbalanced chronic diseases or patient receiving treatment that can interfere with orthodontic treatment or with pain assessment (antibiotics, analgesics, treatment of bone and mineral metabolism, diabetes, hormonal treatments excluding contraceptives)
Show all 13Show fewer
- with a Class II dental unilateral and asymmetric
- with a dental anomaly from shape and / or structure related to the following teeth: maxillary canines and first molars causing an increased risk of detachment brackets
- with anomalies of number : agenesis of permanent teeth
- with a mixed dentition
- refusing to give consent or with one or two parents refusing to give their consent (for minor patients)
- participating in another biomedical research
- pregnant
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de NANTES - Service d'odontologie restauratrice et chirurgicale, UIC odontologie
Nantes, 44042 Nantes Cedex
About this study
Official title: Single-center, Controlled, Randomized and Double-blind Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement.
It is a single-center, prospective clinical study of a medical device, controlled, randomized, non-stratified, double-blind (neither the patient nor the parents know which area is irradiated / practitioner who performs the measures and evaluates the class I achievement or non also ignores the irradiated area) .
Children included in this clinical trial will be their own control, an area receiving LASER irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser) .
Read more
In the maxilla, it will be segmented using a technique by the introduction of sectional side (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support for Intermaxillary Strength II (or Intermaxillary Elastics II).
The patient should put his own Intermaxillary Elastics II, force adapted to the amount of class II dental, and this 24h/24. The patient should position him/herself these intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action, in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor is to place the roots of mandibular molars in the vestibular cortex in order to anchor them there. This allows the lower canines, premolars and maxillary molars under the action of FIM without causing mutual advancement of the mandibular arch.
This procedure does not differ from the usual treatment. The application of laser diode appears, by biomodulatrice action, to show promising results on accelerating the kinetics of tooth movement during orthodontic treatment. The main hypothesis of the research is an increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay in obtaining the class I for irradiated areas vs. non irradiated ones.
The main objective of this study is to evaluate the effect of the application of low energy laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II (Class II elastics)
- Conditions
- Class II Canine, Intermaxillary Strength, Elastics II, Multi Fasteners Orthodontic Treatment
- Being tested
- (LLLT Low Level Laser Therapy) SiroLaser advance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(LLLT Low Level Laser Therapy) SiroLaser advanceDevice
Irradiation scanning distance of the mucosa over an area ranging from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction, and the CEJ to the bottom of the vestibule in the vertical direction.
| Study group | Role | What they receive |
|---|---|---|
| Right irradiated sector | Other | The low-energy laser (LLLT Low Level Laser Therapy) SIROLaser Advance: laser diode (970nm) is applied twice at day 0 and at M1. For each patient, randomized in this arm, only the right maxillary canine is actually irradiated. Irradiation is performed by scanning an area from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction and the cement enamel junction (CEJ) to the bottom of the vestibule in the vertical direction as well in buccally as in Palatine.
The same procedure will be applied to the left non-irradiated area, the only difference being that the laser will not be activated (placebo, laser inactive). Indeed, only the beam director will be lit and a beep start and end will be heard by the patient. In addition, the practitioner evaluating obtention or not of the class I will not know either which area has been irradiated or not. Receives: Device: (LLLT Low Level Laser Therapy) SiroLaser advance |
| Left irradiated sector | Other | The low-energy laser (LLLT Low Level Laser Therapy) SIROLaser Advance: laser diode (970nm) is applied twice at day 0 and at M1. For each patient, randomized in this arm, only the left maxillary canine is actually irradiated. Irradiation is performed by scanning an area from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction and the cement enamel junction (CEJ) to the bottom of the vestibule in the vertical direction as well in buccally as in Palatine.
The same procedure will be applied to the right non-irradiated area, the only difference being that the laser will not be activated (placebo, laser inactive). Indeed, only the beam director will be lit and a beep start and end will be heard by the patient. In addition, the practitioner evaluating obtention or not of the class I will not know either which area has been irradiated or not. Receives: Device: (LLLT Low Level Laser Therapy) SiroLaser advance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delays in obtaining Class I canine right and left
For each sector, obtaining or not the class I will be assessed each month up to 6 months. The difference of delay in obtaining Class I between sectors will be calculated for each patient. For this reason, the primary outcome assessment will be done after 6 months of follow-up + 18 months of inclusion period, i.e. 24 months after starting inclusions.The comparison will be made from a student test on the difference in time required to obtain Class I between sectors.
If class I is obtained on each sector (right and left) prior to the 6-month FUp, the corresponding visit is considered as the last one for the patient within the study.
Measured: 6 months
Secondary outcomes (3)
Total distance covered by the maxillary canine (mm) until the Class I canine
The total distance until the class I will be collected for each sector and will be compared using a student test.
Measured: 6 months
Intensity pain jaw
Intensity pain jaw while wearing FIM II = quantitative pain assessment in the maxilla via EVA, by right and left during the first 3 days of FIM II port via a patient diary Jaw pain felt in each sector will be collected over 3 days. Comparison to be made each time from a student test on the difference in jaw pain felt across sectors.
Measured: 6 months
speed in obtaining Class I canine right and left
total distance until the class I/ Delay in obtaining Class I
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 posted4 Jul 2014 (estimated)
- Study start16 Oct 2014
- Primary completion13 Dec 2017
- Study completion18 May 2018
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 Class II CanineStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181439
- Sponsor's protocol ID
- RC14_0126
- Other IDs
- 2014-A00471-46
- Acronym
- CINELASER
- Status last verified
- Dec 2018
- First submitted
- 27 Jun 2014
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Perignon B, Bandiaky ON, Fromont-Colson C, Renaudin S, Pere M, Badran Z, Cuny-Houchmand M, Soueidan A. Effect of 970 nm low-level laser therapy on orthodontic tooth movement during Class II intermaxillary elastics treatment: a RCT. Sci Rep. 2021 Dec 1;11(1):23226. doi: 10.1038/s41598-021-02610-7.
PubMed 34853360
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Controlled, Randomized and Double-blind Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement.
- ClinicalTrials.gov ID
- NCT02181439
- Acronym / sponsor ID
- CINELASER / RC14_0126
- Conditions
- Class II Canine, Intermaxillary Strength, Elastics II, Multi Fasteners Orthodontic Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 4 Jul 2014 (estimated)
- 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.
It is a single-center, prospective clinical study of a medical device, controlled, randomized, non-stratified, double-blind (neither the patient nor the parents know which area is irradiated / practitioner who performs the measures and evaluates the class I achievement or non also ignores the irradiated area) .
Children included in this clinical trial will be their own control, an area receiving LASER irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser) .
In the maxilla, it will be segmented using a technique by the introduction of sectional side (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support for Intermaxillary Strength II (or Intermaxillary Elastics II).
The patient should put his own Intermaxillary Elastics II, force adapted to the amount of class II dental, and this 24h/24. The patient should position him/herself these intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action, in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor is to place the roots of mandibular molars in the vestibular cortex in order to anchor them there. This allows the lower canines, premolars and maxillary molars under the action of FIM without causing mutual advancement of the mandibular arch.
This procedure does not differ from the usual treatment. The application of laser diode appears, by biomodulatrice action, to show promising results on accelerating the kinetics of tooth movement during orthodontic treatment. The main hypothesis of the research is an increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay in obtaining the class I for irradiated areas vs. non irradiated ones.
The main objective of this study is to evaluate the effect of the application of low energy laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II (Class II elastics)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right irradiated sector | Other | Device: (LLLT Low Level Laser Therapy) SiroLaser advanceThe low-energy laser (LLLT Low Level Laser Therapy) SIROLaser Advance: laser diode (970nm) is applied twice at day 0 and at M1. For each patient, randomized in this arm, only the right maxillary canine is actually irradiated. Irradiation is performed by scanning an area from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction and the cement enamel junction (CEJ) to the bottom of the vestibule in the vertical direction as well in buccally as in Palatine. The same procedure will be applied to the left non-irradiated area, the only difference being that the laser will not be activated (placebo, laser inactive). Indeed, only the beam director will be lit and a beep start and end will be heard by the patient. In addition, the practitioner evaluating obtention or not of the class I will not know either which area has been irradiated or not. |
| Left irradiated sector | Other | Device: (LLLT Low Level Laser Therapy) SiroLaser advanceThe low-energy laser (LLLT Low Level Laser Therapy) SIROLaser Advance: laser diode (970nm) is applied twice at day 0 and at M1. For each patient, randomized in this arm, only the left maxillary canine is actually irradiated. Irradiation is performed by scanning an area from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction and the cement enamel junction (CEJ) to the bottom of the vestibule in the vertical direction as well in buccally as in Palatine. The same procedure will be applied to the right non-irradiated area, the only difference being that the laser will not be activated (placebo, laser inactive). Indeed, only the beam director will be lit and a beep start and end will be heard by the patient. In addition, the practitioner evaluating obtention or not of the class I will not know either which area has been irradiated or not. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- With a Class II canine complete or partial, bilateral and symmetrical
- In permanent dentition (no deciduous teeth in the arch)
- Requiring the use of intermaxillary strength (FIM) II correction dental class II during a multi fasteners orthodontic treatment
- Leveling done beforehand*
- Anchor of the mandible is maximum
Key exclusion criteria (13 listed)
- having a mental deficiency or child who can not read or write (difficulties in completing the questionnaire )
- with lack of cooperation (withdrawal, refuse to wear FIM II)
- who missed at least 3 consecutive appointments according to the medical record ,
- with orofacial malignant tumor
- having unbalanced chronic diseases or patient receiving treatment that can interfere with orthodontic treatment or with pain assessment (antibiotics, analgesics, treatment of bone and mineral metabolism, diabetes, hormonal treatments excluding contraceptives)
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 |
|---|---|---|
| (LLLT Low Level Laser Therapy) SiroLaser advanceIrradiation scanning distance of the mucosa over an area ranging from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction, and the CEJ to the bottom of the vestibule in the vertical direction. | Device | Left irradiated sector, Right irradiated sector |
Primary outcome
Delays in obtaining Class I canine right and left
Time frame: 6 months
For each sector, obtaining or not the class I will be assessed each month up to 6 months. The difference of delay in obtaining Class I between sectors will be calculated for each patient. For this reason, the primary outcome assessment will be done after 6 months of follow-up + 18 months of inclusion period, i.e. 24 months after starting inclusions.The comparison will be made from a student test on the difference in time required to obtain Class I between sectors. If class I is obtained on each sector (right and left) prior to the 6-month FUp, the corresponding visit is considered as the last one for the patient within the study.
3 secondary outcomes
Total distance covered by the maxillary canine (mm) until the Class I canine
Time frame: 6 months
Intensity pain jaw
Time frame: 6 months
speed in obtaining Class I canine right and left
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 14 Sep 2026.
- Results publication: PubMed 34853360Perignon B, Bandiaky ON, Fromont-Colson C, Renaudin S, Pere M, Badran Z, Cuny-Houchmand M, Soueidan A. Effect of 970 nm low-level laser therapy on orthodontic tooth movement during Class II intermaxillary elastics treatment: a RCT. Sci Rep. 2021 Dec 1;11(1):23226. doi: 10.1038/s41598-021-02610-7.
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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 (LLLT Low Level Laser Therapy) SiroLaser advance in people with Class II Canine and Intermaxillary Strength, run by Nantes University Hospital at 1 site in France.
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 6 inclusion and 13 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 14 Sep 2026. 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 France. 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?
Delays in obtaining Class I canine right and left (time frame: 6 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 NCT02181439, 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 14 Sep 2026.