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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553407
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Isabel Peixoto Tortamano, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Pulpitis - Irreversible Device: Low Level Laser - Pulse Device: Low Level Laser - continuous Device: Low Level Laser - placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars. Randomized, Double Blind Study.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Experimental: Low Level Laser - Pulse
In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm², 25 Hz
Device: Low Level Laser - Pulse
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.

Experimental: Low Level Laser - continuous
In this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm²
Device: Low Level Laser - continuous
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.

Placebo Comparator: Low Level Laser - Placebo
In this group the patient will receive the protocol with the equipment turned off.
Device: Low Level Laser - placebo
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 Measures :
  1. Pain reduction in VAS score [ Time Frame: 10 minutes ]
    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 :
  1. Analgesia [ Time Frame: 30 minutes ]
    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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553407


Contacts
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Contact: Isabel F Tortamano 551130918030 iptortam@usp.br

Locations
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Brazil
University of Sao Paulo Recruiting
São Paulo, Brazil, 05508-000
Contact: Isabel P Tortamano, Phd    +55 11 30917813    iptortam@usp.br   
Sponsors and Collaborators
University of Sao Paulo

Publications of Results:
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Responsible Party: Isabel Peixoto Tortamano, professor of the department of stomatology of the university of sao paulo, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03553407    
Other Study ID Numbers: Laser
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Isabel Peixoto Tortamano, University of Sao Paulo:
Low level laser
Pulpitis
Mandibular molars
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs