Pain, Postoperative Clinical Trial
Official title:
Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study
The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument. ;
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