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NCT Number: NCT02169102

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry - University of São Paulo

São Paulo, 05508-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-Intact Pulp chamber
  • Necrotic pulp

Treatment and study plan

No additional Intervention (control)

Other

No additional intervention previously to the urgency endodontic treatment (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.

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 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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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