Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.
Evaluation of the Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars. Randomized, Double Blind Study.
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 13, 2019
March 1, 2019
2 years
December 12, 2017
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Analgesia
30 minutes
Study Arms (3)
Low Level Laser - Pulse
EXPERIMENTALIn this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm², 25 Hz
Low Level Laser - continuous
EXPERIMENTALIn this group the patient will receive the following laser protocol: 880nm, 30mW, 3.6 J / cm²
Low Level Laser - Placebo
PLACEBO COMPARATORIn this group the patient will receive the protocol with the equipment turned off.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- ASA I patients, according to the classification of the American Society of Anesthesiology (ASA)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, 05508-000, Brazil
Related 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. doi: 10.1007/s10103-016-2068-7. Epub 2016 Oct 1.
PMID: 27696017RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of the department of stomatology of the university of sao paulo
Study Record Dates
First Submitted
December 12, 2017
First Posted
June 12, 2018
Study Start
March 1, 2018
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share