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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Pulpitis
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508-000
    • School of Dentistry - University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-Intact Pulp chamber
• Necrotic pulp

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 18, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Low power laser; Pulpitis
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Inflammation; Acute Pain; Pulpitis
• Other Study ID Numbers: 08509912.3.0000.0075