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

Pulpitis - Irreversible Clinical Trial

Official title:

Evaluation of the Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars. Randomized, Double Blind Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03553407
• Other study ID #: Laser
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2019
• Source: University of Sao Paulo
• Contact: Isabel F Tortamano
• Phone: 551130918030
• Email: iptortam[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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, ß-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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Epub 2016 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 minutes
Secondary	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	30 minutes