Effect of Low Power Laser in Tooth Pain Modulation Caused by Irreversible Inflammation

Study Overview
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Brief Summary
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Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups: Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation. The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.

Official Title
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Effect of Low Power Laser in Pain Modulation During Irreversible Inflammation of Tooth Pulp

Conditions
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Pulpitis, Acute Pain

Intervention / Treatment
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* Other: No additional Intervention (control)
* Radiation: Sham Laser Irradiation
* Radiation: Laser 1 (at 0,16 Joules/point of irradiation)
* Radiation: Laser 2 (1,6 Joules/point of irradiation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute pain due to irreversible inflammation of the a vital pulp tooth Exclusion Criteria: Non-Intact Pulp chamber Necrotic pulp

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br> | Other: No additional Intervention (control)<br>* No additional intervention previously to the urgency endodontic treatment (Control)<br>|
| Sham Comparator: Sham Laser<br> | Radiation: Sham Laser Irradiation<br>* Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.<br>|
| Experimental: Laser 1<br>Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation | Radiation: Laser 1 (at 0,16 Joules/point of irradiation)<br>* Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 0,16 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)<br>|
| Experimental: Laser 2<br>Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation | Radiation: Laser 2 (1,6 Joules/point of irradiation)<br>* Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 1,6 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation | Pain will be measured through VAS (Visual Analog Scale). | Immediately after low power laser irradiation and 15 minutes after low power laser irradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of anesthetic supplementation during urgency endodontic treatment | 15 minutes after low power laser irradiation, patients will be submitted to endodontic urgency treatment adopted in School of Dentistry of University of São Paulo. The need of local anesthetic supplementation will be observed between the patients | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low power laser, Pulpitis, Pain