Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device

NCT ID: NCT01745653

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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

Conditions

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Bad Molar Teeth Arrangement Requiring Orthodontic Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low level laser therapy

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.

Group Type EXPERIMENTAL

Low level laser therapy

Intervention Type DEVICE

sham procedure

Same procedure than experimental arm except that the laser is not activated.

Group Type SHAM_COMPARATOR

sham procedure

Intervention Type PROCEDURE

no intervention

no intervention : Patient received the quadhelix with nothing else

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low level laser therapy

Intervention Type DEVICE

sham procedure

Intervention Type PROCEDURE

Other Intervention Names

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low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory) Same intervention than experimental arm except that the laser is not activated

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nantes Universitary Hospital

Nantes, Loire Atlantique, France

Site Status

Countries

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France

Other Identifiers

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BRD11/3-J

Identifier Type: -

Identifier Source: org_study_id

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