- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553407
Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars.
March 12, 2019 updated by: Isabel Peixoto Tortamano, University of Sao Paulo
Evaluation of the Analgesic Effect of Low Intensity Laser in Patients With Pulpitis of Mandibular Molars. Randomized, Double Blind Study.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Isabel F Tortamano
- Phone Number: 551130918030
- Email: iptortam@usp.br
Study Locations
-
-
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São Paulo, Brazil, 05508-000
- Recruiting
- University of Sao Paulo
-
Contact:
- Isabel P Tortamano, Phd
- Phone Number: +55 11 30917813
- Email: iptortam@usp.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
December 12, 2017
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LASER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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