An interventional study of No additional Intervention (control) and Sham Laser Irradiation in Pulpitis and Acute Pain, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-14.
Sponsored by University of Sao Paulo · Not applicable and Interventional
Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups:
Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.
The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 275 interventional studies indexed under Pulpitis.
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Exclusion Criteria:
Other: No additional Intervention (control)
Radiation: Sham Laser Irradiation
Low Power Laser applied at 0.16 Joules/point. 2 points of laser irradiation
Radiation: Laser 1 (at 0,16 Joules/point of irradiation)
Low Power Laser applied at 16 Joules/point. 2 points of laser irradiation
Radiation: Laser 2 (1,6 Joules/point of irradiation)
No additional intervention previously to the urgency endodontic treatment (Control)
Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.
Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 0,16 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 1,6 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
Tooth pain modulation during irreversible pulp inflammation after low power laser irradiation
Pain will be measured through VAS (Visual Analog Scale).
Time frame: Immediately after low power laser irradiation and 15 minutes after low power laser irradiation
Need of anesthetic supplementation during urgency endodontic treatment
15 minutes after low power laser irradiation, patients will be submitted to endodontic urgency treatment adopted in School of Dentistry of University of São Paulo. The need of local anesthetic supplementation will be observed between the patients
Time frame: 15 minutes
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo