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

NCT ID: NCT03553407

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-06-01

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.

Conditions

Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low Level Laser - Pulse

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

Group Type: EXPERIMENTAL

Low Level Laser - Pulse

Intervention Type: DEVICE

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.

Low Level Laser - continuous

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

Group Type: EXPERIMENTAL

Low Level Laser - continuous

Intervention Type: DEVICE

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.

Low Level Laser - Placebo

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

Group Type: PLACEBO_COMPARATOR

Low Level Laser - placebo

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Isabel Peixoto Tortamano

professor of the department of stomatology of the university of sao paulo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Sao Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Isabel F Tortamano

Role: CONTACT

iptortam@usp.br

551130918030

Facility Contacts

Isabel P Tortamano, Phd

Role: primary

iptortam@usp.br

+55 11 30917813

References

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.

Reference Type: RESULT

PMID: 27696017 (View on PubMed)

Other Identifiers

Laser

Identifier Type: -

Identifier Source: org_study_id