Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial
Open Access
- 6 November 2013
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 14 (1), 373
- https://doi.org/10.1186/1745-6215-14-373
Abstract
Background: Low-level laser therapy (LLLT) has been shown to modulate the inflammatory process without adverse effects , by reducing pain and swelling and promoting the repair of damaged tissues. Because pain, swelling and muscle spasm are complications found in virtually all patients following oral surgery for the removal of impacted teeth, this model has been widely used to evaluate the effects of LLLT on the inflammatory process involving bone and, connective tissue and the muscles involved in mastication. Methods/Design: After meeting the eligibility criteria, 60 patients treated at a Specialty Dental Center for the removal of impacted lower third molars will be randomly divided into five groups according to the type of laser therapy used at the end of surgery (intraoral irradiation with 660 nm laser; extraoral irradiation with 660 nm laser; intraoral irradiation with 808 nm laser; extraoral irradiation with 808 nm laser and no irradiation). To ensure that patients are blinded to the type of treatment they are receiving, the hand piece of the laser apparatus will be applied both intraorally and extraorally to all participants, but the device will be turned on only at the appropriate time, as determined by the randomization process. At 2 and 7 days after surgery, the patients will be evaluated by three blinded evaluators who will measure of swelling, mouth opening (muscle spasm evaluation) and pain (using two different pain scales). The 14-item Oral Health Impact Profile (OHIP-14) will be used to assess QOL. All data will be analyzed with respect to the normality of distribution using the Shapiro-Wilk test. Statistically significant differences between the experimental groups will be determined using analysis of variance, followed by a suitable post hoc test, when necessary. The significance level will be set at α = 0.05. Discussion: The lack of standardization in studies with regard to the samples, methods and LLLT parameters complicates the determination of the actual effect of laser therapy on this model. The present study aims to provide a randomized, controlled, double-blind trial to compare four different LLLT parameters in relation to the outcomes of pain, swelling and muscle spasm following surgery for the extraction of impacted third molars and evaluate the effects os surgery on patients' quality os life (QOL). Trial registration: Brazilian Registry of Clinical Trials - Rebec (RBR-6XSB5H).This publication has 34 references indexed in Scilit:
- Relationship Between Oral Health-Related Quality of Life and the Position of the Lower Third Molar: Postoperative Follow-UpJournal of Oral and Maxillofacial Surgery, 2012
- Phototherapy with low-level laser affects the remodeling of types I and III collagen in skeletal muscle repairLasers in Medical Science, 2011
- Effect of age, impaction types and operative time on inflammatory tissue reactions following lower third molar surgeryHead & Face Medicine, 2011
- Influence of Laser Photobiomodulation on Collagen IV During Skeletal Muscle Tissue Remodeling After Injury in RatsPhotomedicine and Laser Surgery, 2011
- Effects of low-level laser therapy on expression of TNF-α and TGF-β in skeletal muscle during the repair processLasers in Medical Science, 2010
- Placebo-controlled randomized clinical trial of the effect two different low-level laser therapies (LLLT)—intraoral and extraoral—on trismus and facial swelling following surgical extraction of the lower third molarLasers in Medical Science, 2009
- Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenacOral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, 2006
- Quality of life following lower third molar removalInternational Journal of Oral & Maxillofacial Surgery, 2006
- The effect of soft-laser application on postoperative pain and swelling: A double-blind, crossover studyInternational Journal of Oral & Maxillofacial Surgery, 1993
- A randomised double blind comparative study of low level laser therapy following surgical extraction of lower third molar teethBritish Journal of Oral and Maxillofacial Surgery, 1993