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

NCT02169102 | Completed

• 1 other identifier: 08509912.3.0000.0075
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis; Acute Pain

Keywords

Low power laser; Pulpitis; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need of anesthetic supplementation during urgency endodontic treatment

  15 minutes

Study Arms (4)

Control

OTHER

Other: No additional Intervention (control)

Sham Laser

SHAM COMPARATOR

Radiation: Sham Laser Irradiation

Laser 1

EXPERIMENTAL

Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation

Radiation: Laser 1 (at 0,16 Joules/point of irradiation)

Laser 2

EXPERIMENTAL

Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation

Radiation: Laser 2 (1,6 Joules/point of irradiation)

Interventions

No additional Intervention (control) OTHER

No additional intervention previously to the urgency endodontic treatment (Control)

Control

Sham Laser Irradiation RADIATION

Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.

Sham Laser

Laser 1 (at 0,16 Joules/point of irradiation) RADIATION

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)

Laser 1

Laser 2 (1,6 Joules/point of irradiation) RADIATION

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)

Laser 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-Intact Pulp chamber
• Necrotic pulp

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

School of Dentistry - University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Pulpitis; Acute Pain; Pain

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larissa MP Souza, DDS

  School of Dentistry - University of São Paulo

  STUDY CHAIR

• Carlos A Adde, PhD

  School of Dentistry - University of São Paulo

  STUDY CHAIR

• Karen M Ramalho, PhD

  School of Dentistry - University of São Paulo

  PRINCIPAL INVESTIGATOR

• Isabel P Tortamano, PhD

  School of Dentistry - University of São Paulo

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

BR (1)