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

NCT ID: NCT02169102

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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Pulpitis Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Group Type OTHER

No additional Intervention (control)

Intervention Type OTHER

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

Sham Laser

Group Type SHAM_COMPARATOR

Sham Laser Irradiation

Intervention Type RADIATION

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

Laser 1

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

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Group Type EXPERIMENTAL

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

Intervention Type 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)

Interventions

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No additional Intervention (control)

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

Intervention Type OTHER

Sham Laser Irradiation

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

Intervention Type 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)

Intervention Type 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)

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Karen Müller Ramalho

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larissa MP Souza, DDS

Role: STUDY_CHAIR

School of Dentistry - University of São Paulo

Carlos A Adde, PhD

Role: STUDY_CHAIR

School of Dentistry - University of São Paulo

Karen M Ramalho, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry - University of São Paulo

Isabel P Tortamano, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry - University of São Paulo

Carlos P Eduardo, PhD

Role: STUDY_DIRECTOR

School of Dentistry - University of São Paulo

Rodney G Rocha, PhD

Role: STUDY_DIRECTOR

School of Dentistry - University of São Paulo

Locations

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School of Dentistry - University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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08509912.3.0000.0075

Identifier Type: -

Identifier Source: org_study_id

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