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Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low Level Laser - Pulse
Low Level Laser - continuous
Low Level Laser - placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Low level laser, Pulpitis, Mandibular molars

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I patients, according to the classification of the American Society of Anesthesiology (ASA)
  • 18 and 50 years
  • Systolic pressure below 140 mmHg and diastolic below 90 mmHg and heart rate between 70 - / + 20 beats / minute
  • Pulpectomy in the first and / or lower second molars, which has at least one adjacent molar tooth and a contralateral canine; or absence of deep cavities, extensive restorations, advanced periodontal disease and no history of trauma or sensitivity.

Exclusion Criteria:

  • Patients with a history of sensitivity to local anesthetics and sulfur
  • Pregnant or suspected of pregnancy
  • Users of medications that may interact with the local anesthetic, such as, anxiolytics, antidepressants, antipsychotics, β-blockers and antihistaminic agents
  • Patients with septic process near the injection site
  • Patients under orthodontic treatment
  • Patients with heart disease, neurological disease, hyperthyroidism and diabetes; drug users.

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low Level Laser - Pulse

Low Level Laser - continuous

Low Level Laser - Placebo

Arm Description

In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm², 25 Hz

In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm²

In this group the patient will receive the protocol with the equipment turned off.

Outcomes

Primary Outcome Measures

Pain reduction in VAS score
The success of laser use was defined as a reduction of more than 2 in the patient's pain report between the initial moment and 10 minutes after the laser application

Secondary Outcome Measures

Analgesia
The success of IANB associated with laser therapy will be defined as the ability to access the pulp chamber and perform the pulpectomy without the pain being classified as uncomfortable by the patient (0 to 1 scale) during the treatment,which takes almost 30 minutes to be completed

Full Information

First Posted
December 12, 2017
Last Updated
March 12, 2019
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03553407
Brief Title
Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.
Official Title
Evaluation of the Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars. Randomized, Double Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study has the objective of evaluating whether the previous therapy with low intensity laser, through its analgesic effect, can promote a greater comfort specifically for patient with pulpitis in mandibular molars. 75 patients with pain from mandibular molar pulpitis will be selected for this study (randomized and double blind) and divided into 3 groups (n = 25): Group 1 - Pulse Laser (880nm, 30mW, 3,6J / cm², 25Hz) ; Group 2 - Continuous Laser (880nm; 30mW; 3.6J / cm²); Group 3 - Placebo. The efficacy of the laser will be assessed using the VAS scale 10 minutes after the laser application, immediately before the blockade is performed.
Detailed Description
Anxiety, pain and discomfort are situations of great stress in the daily routine of clinical practice, and especially in the practice of the dental emergency sector. Several studies have concluded that low-intensity laser therapy has been shown to be effective in pain management. However, the majority report the use of laser in the treatment of chronic pain, few studies show its application in acute pain and only one study evaluated the effect of low laser on acute pain of pulp inflammation, but with other parameters. In addition, because of the inflammatory process and several factors of unknown origin, the anesthetic agent can not always promote complete analgesia, especially when faced with mandibular molars. Therefore, the present study has the objective of evaluating whether the previous therapy with low intensity laser, through its analgesic effect, can promote a greater comfort specifically for this type of patient. 75 patients with pain from mandibular molar pulpitis will be selected for this study (randomized and double blind) and divided into 3 groups (n = 25): Group 1 - Pulse Laser (880nm, 30mW, 3,6J / cm², 25Hz) ; Group 2 - Continuous Laser (880nm; 30mW; 3.6J / cm²); Group 3 - Placebo. The pain will be evaluated by means of an VAS score in 6 different times: initial pain, immediately after and 10 minutes after irradiation with the laser, 10 minutes after inferior alveolar nerve block (IANB), during conventional endodontic treatment, after the end of the procedure. (T0, T1, T1 ', T2, T3 and T4). The efficacy of the laser application will be assessed using the VAS scale 10 minutes after the laser application, immediately before the blockade is performed. The use of the laser will be considered effective if the patient reports a reduction in the VAS scale of 2 points, between the initial moment and 10 minutes after the laser application. Analgesia will be evaluated during the pulpectomy procedure with the use of the verbal analogue scale 0 to 3. Analgesic effect will be considered if the professional can finish the procedure without the patient reporting 2 or 3 on this scale. The data obtained between the different groups and schedules will be compared statistically, and the statistical test chosen will depend on the normality of the data. The data obtained between the different groups and times will be compared statistically, and the statistical test chosen will depend on the normality of the data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
Low level laser, Pulpitis, Mandibular molars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Level Laser - Pulse
Arm Type
Experimental
Arm Description
In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm², 25 Hz
Arm Title
Low Level Laser - continuous
Arm Type
Experimental
Arm Description
In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm²
Arm Title
Low Level Laser - Placebo
Arm Type
Placebo Comparator
Arm Description
In this group the patient will receive the protocol with the equipment turned off.
Intervention Type
Device
Intervention Name(s)
Low Level Laser - Pulse
Intervention Description
The laser will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
Intervention Type
Device
Intervention Name(s)
Low Level Laser - continuous
Intervention Description
The laser will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
Intervention Type
Device
Intervention Name(s)
Low Level Laser - placebo
Intervention Description
placebo will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
Primary Outcome Measure Information:
Title
Pain reduction in VAS score
Description
The success of laser use was defined as a reduction of more than 2 in the patient's pain report between the initial moment and 10 minutes after the laser application
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Analgesia
Description
The success of IANB associated with laser therapy will be defined as the ability to access the pulp chamber and perform the pulpectomy without the pain being classified as uncomfortable by the patient (0 to 1 scale) during the treatment,which takes almost 30 minutes to be completed
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I patients, according to the classification of the American Society of Anesthesiology (ASA) 18 and 50 years Systolic pressure below 140 mmHg and diastolic below 90 mmHg and heart rate between 70 - / + 20 beats / minute Pulpectomy in the first and / or lower second molars, which has at least one adjacent molar tooth and a contralateral canine; or absence of deep cavities, extensive restorations, advanced periodontal disease and no history of trauma or sensitivity. Exclusion Criteria: Patients with a history of sensitivity to local anesthetics and sulfur Pregnant or suspected of pregnancy Users of medications that may interact with the local anesthetic, such as, anxiolytics, antidepressants, antipsychotics, β-blockers and antihistaminic agents Patients with septic process near the injection site Patients under orthodontic treatment Patients with heart disease, neurological disease, hyperthyroidism and diabetes; drug users.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel F Tortamano
Phone
551130918030
Email
iptortam@usp.br
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel P Tortamano, Phd
Phone
+55 11 30917813
Email
iptortam@usp.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27696017
Citation
Ramalho KM, de Souza LM, Tortamano IP, Adde CA, Rocha RG, de Paula Eduardo C. A randomized placebo-blind study of the effect of low power laser on pain caused by irreversible pulpitis. Lasers Med Sci. 2016 Dec;31(9):1899-1905. doi: 10.1007/s10103-016-2068-7. Epub 2016 Oct 1.
Results Reference
result

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Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.

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