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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169102
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Karen Müller Ramalho, University of Sao Paulo

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pulpitis Acute Pain 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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Effect of Low Power Laser in Pain Modulation During Irreversible Inflammation of Tooth Pulp
Study Start Date : February 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Control Other: No additional Intervention (control)
No additional intervention previously to the urgency endodontic treatment (Control)

Sham Comparator: Sham Laser Radiation: Sham Laser Irradiation
Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.

Experimental: Laser 1
Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation
Radiation: Laser 1 (at 0,16 Joules/point of irradiation)
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)

Experimental: Laser 2
Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation
Radiation: Laser 2 (1,6 Joules/point of irradiation)
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)




Primary Outcome Measures :
  1. Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation [ Time Frame: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation ]
    Pain will be measured through VAS (Visual Analog Scale).


Secondary Outcome Measures :
  1. Need of anesthetic supplementation during urgency endodontic treatment [ Time Frame: 15 minutes ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute pain due to irreversible inflammation of the a vital pulp tooth

Exclusion Criteria:

  • Non-Intact Pulp chamber
  • Necrotic pulp

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169102


Locations
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Brazil
School of Dentistry - University of São Paulo
São Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Chair: Larissa MP Souza, DDS School of Dentistry - University of São Paulo
Study Chair: Carlos A Adde, PhD School of Dentistry - University of São Paulo
Principal Investigator: Karen M Ramalho, PhD School of Dentistry - University of São Paulo
Principal Investigator: Isabel P Tortamano, PhD School of Dentistry - University of São Paulo
Study Director: Carlos P Eduardo, PhD School of Dentistry - University of São Paulo
Study Director: Rodney G Rocha, PhD School of Dentistry - University of São Paulo
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Responsible Party: Karen Müller Ramalho, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02169102    
Other Study ID Numbers: 08509912.3.0000.0075
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Keywords provided by Karen Müller Ramalho, University of Sao Paulo:
Low power laser
Pulpitis
Pain
Additional relevant MeSH terms:
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Pulpitis
Inflammation
Acute Pain
Pathologic Processes
Pain
Neurologic Manifestations
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases