Bad Molar Teeth Arrangement Requiring Orthodontic DeviceOrtholaserNCT01745653
Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device
A study testing Low level laser therapy in people with Bad Molar Teeth Arrangement Requiring Orthodontic Device, run by Nantes University Hospital at 1 site in France.
Trial summary
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Bad Molar Teeth Arrangement Requiring Orthodontic Device
- What is being tested?
- Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Jan 2013
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 8 and 15 years old who need to receive an orthodontic device ("quadhelix)
- informed consent form signed by parents who should be affiliated to French health insurance (french Social security)
Who cannot join
- malignant facial tumor
- not able to read or write correctly and thus not able to complete the questionnaire
- allergic or intolerant to paracetamol
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.
As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.
Read the detailed description
Patient will be randomized into one of the 3 following arms :
- arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix.
- arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated.
- arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed
- Being tested
- Low level laser therapy, sham procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
Also called low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory)
sham procedureProcedure or surgery
Also called Same intervention than experimental arm except that the laser is not activated
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Low level laser (970nm) will be delivered on the mucous membrane in regard to the first molar teeth on which rings of the quadhelix have been settled. Receives: Device: Low level laser therapy |
| sham procedure | Sham comparator | Same procedure than experimental arm except that the laser is not activated. Receives: Procedure: sham procedure |
| no intervention | No intervention | no intervention : Patient received the quadhelix with nothing else |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale
Measured: change from baseline pain at 7 days
Secondary outcomes (2)
effect of low level laser therapy on intake of antalgics
Each day during the first week post procedure, patient will record his/her intake of antalgics
Measured: change from baseline antalgics intake at 7 days
quality of food intake
Each day during the first week post procedure, patient will answer (on a questionnaire) to questions concerning his/her intake of food (type of food (soft or not)).
Measured: change from baseline quality of food intake at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bad Molar Teeth Arrangement Requiring Orthodontic DeviceStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 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
- NCT01745653
- Sponsor's protocol ID
- BRD11/3-J
- Acronym
- Ortholaser
- Status last verified
- Feb 2013
- First submitted
- 4 Dec 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"
- ClinicalTrials.gov ID
- NCT01745653
- Acronym / sponsor ID
- Ortholaser / BRD11/3-J
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Dec 2012 (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.
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.
As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.
Detailed description
Patient will be randomized into one of the 3 following arms :
- arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix.
- arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated.
- arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Device: Low level laser therapyLow level laser (970nm) will be delivered on the mucous membrane in regard to the first molar teeth on which rings of the quadhelix have been settled. |
| sham procedure | Sham comparator | Procedure: sham procedureSame procedure than experimental arm except that the laser is not activated. |
| no intervention | No intervention | –no intervention : Patient received the quadhelix with nothing else |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 8 and 15 years old who need to receive an orthodontic device ("quadhelix)
- informed consent form signed by parents who should be affiliated to French health insurance (french Social security)
Key exclusion criteria (4 listed)
- malignant facial tumor
- not able to read or write correctly and thus not able to complete the questionnaire
- allergic or intolerant to paracetamol
- Informed consent not obtained
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 therapyAlso: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory) | Device | Low level laser therapy |
| sham procedureAlso: Same intervention than experimental arm except that the laser is not activated | Procedure or surgery | sham procedure |
Primary outcome
to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
Time frame: change from baseline pain at 7 days
Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale
2 secondary outcomes
effect of low level laser therapy on intake of antalgics
Time frame: change from baseline antalgics intake at 7 days
quality of food intake
Time frame: change from baseline quality of food intake at 7 days
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 5 Feb 2013.
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 Bad Molar Teeth Arrangement Requiring Orthodontic Device, 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 2 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 5 Feb 2013. 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. 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?
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?
to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device) (time frame: change from baseline pain at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2013.