Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial

Hélio Sampaio-Filho, Juliane Sotto-Ramos, Erika Horácio Pinto, Marcia Regina Cabral, Priscila Larcher Longo, Isabel Peixoto Tortamano, Rodrigo Labat Marcos, Daniela Fátima Teixeira Silva, Christine Pavani, Anna Carolina Ratto Tempestini Horliana, Hélio Sampaio-Filho, Juliane Sotto-Ramos, Erika Horácio Pinto, Marcia Regina Cabral, Priscila Larcher Longo, Isabel Peixoto Tortamano, Rodrigo Labat Marcos, Daniela Fátima Teixeira Silva, Christine Pavani, Anna Carolina Ratto Tempestini Horliana

Abstract

Background: A comfortable postoperative return to daily activities has increased the need to control inflammation after third molar surgery. Anti-inflammatory drugs and analgesics are not exempt from adverse effects such as allergies and chronic gastritis, and they are not without cost. The association between low-level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated. Among its advantages, we can mention the low risk of side effects, low cost and simplicity of application. The objective of this study is to evaluate the efficiency of low-level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery.

Methods/design: Ninety bilateral, symmetrical lower third molar surgeries will be performed in 45 healthy patients. Each patient will be their own control, through a split-mouth crossover study. One side of the mouth will be randomly chosen and, immediately after surgery, will be treated with low-level laser. After 21 days, the contralateral side will be operated on with low-level laser simulation used postoperatively. This regimen (laser application or not) will be repeated at 24 and 48 h after surgery. All patients will be requested to take analgesics (acetaminophen) if they have pain, i.e. in case of pain. Neither the surgeon nor the patients will know the assigned treatment. The primary variable will be postoperative pain assessed using a Visual Analog Scale, and the secondary variables will be trismus, edema, local temperature, dysphagia, presence of infection and painkiller ingestion. These variables will be assessed at baseline, 24 h, 48 h and 7 days after surgery. Blood samples for systemic inflammatory cytokine (TNF-α, IL-1, IL-6 and IL-8) analysis will be assessed at baseline and 24 h after surgery.

Discussion: Some authors believe that using a wavelength of 633 to 670 nm is a good option for laser therapy in the field of acupuncture. This wavelength can penetrate biological tissue to a depth of about 3 mm. However, for auriculotherapy points, the stimulus (mustard seeds, needles 1 to 2.5 mm) does not penetrate so deeply. For this reason, we chose a laser wavelength of 660 nm (red wavelength).

Trial registration: ClinicalTrials.gov Identifier: NCT02657174 , registered on 11 January 2016.

Keywords: Auriculotherapy; Laser; Pain; Postoperative; Third molar surgery.

Figures

Fig. 1
Fig. 1
Auricular acupuncture points. Legend: (1) Shen Men, (2) Sympathetic (SNV), (3) Stomach, (4) Toothache 3, (5) Jaw, (6) Adrenal
Fig. 2
Fig. 2
The criteria for the determination of edema. Legend: (I) The corner of the eye to the angle of the jaw, (II) The tragus to the labial commissure, and (III) The tragus to pogonion
Fig. 3
Fig. 3
Flowchart presenting an overview of the study
Fig. 4
Fig. 4
Template of recommended content for the schedule of enrollment, interventions and assessments.* Legend: *Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols (Additional file 1)

References

    1. Pouchain EC, Costa FWG, Bezerra TP, Soares ECS. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study. Int J Oral Maxillofac Surg. 2015;44:876–84. doi: 10.1016/j.ijom.2014.10.026.
    1. Ferrante M, Petrini M, Trentini P, Perfetti G, Spoto G. Effect of low-level laser therapy after extraction of impacted lower third molars. Lasers Med Sci. 2013;28:845–9. doi: 10.1007/s10103-012-1174-4.
    1. Markovic AB, Todorovic L. Postoperative analgesia after lower third molar surgery: contribution of the use of long-acting local anesthetics, low-power laser, and diclofenac. Oral Surg Oral Med Oral Pathol Oral Radio Endod. 2006;102:e4–8. doi: 10.1016/j.tripleo.2006.02.024.
    1. Zuniga JR, Phillips CL, Shugars D, Lyon JA, Peroutika SJ, Swarbric J, Bon C. Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain. J Oral Maxillofac Surg. 2004;62:806–15. doi: 10.1016/j.joms.2003.12.019.
    1. Fragyscos FD. Perioperative and post-operative complications in oral surgery. Berlin: Heidelberg: Springer-Verlag;2010. ISBN 3642064310, 9783642064319.
    1. He WL, Yu FY, Pan J, Zhuang R, Duam PJ. A systematic review and meta-analysis on the efficacy of low-level laser therapy in the management of complication after mandibular third molar surgery. Lasers Med Sci. 2015;30:1779–88. doi: 10.1007/s10103-014-1634-0.
    1. Mandegaran R, Conway C, Elton C. Lower gastrointestinal adverse effects of NSAIDS: an extreme example of a common problem. BMJ Case Rep. 2013. doi: 10.1136/bcr-2012-008274.
    1. Han JB, Keller EE, Grothe RM. Postoperative gastrointestinal bleeding in orthognathic surgery patients: its estimated prevalence and possible association to known risk factors. J Oral Maxillofac Surg. 2014;72:2043–51. doi: 10.1016/j.joms.2014.02.039.
    1. Wilcox CM, Alexander LN, Cotsonis GA, Clark WS. Nonsteroidal anti-inflammatory drugs are associated with both upper and lower gastrointestinal bleeding. Dig Dis Sci. 1997;42:990–7. doi: 10.1023/A:1018832902287.
    1. Rabischong P, Terral C. Scientific basis of auriculotherapy: state of the art. Med Acupunct. 2014;26:84–96.
    1. Yeh CH, Chiang YC, Hoffman SL, Liang Z, Klem ML, Tam WW, Chien LC, Suen LK.Efficacy of auricular therapy for pain management: a systematic review andmeta-analysis. Evid Based Complement Alternat Med. 2014;2014:934670. doi:10.1155/2014/934670. Epub 2014 Jul 23. Review.
    1. Litscher G, Opitz G. Technical Parameters for Laser Acupuncture to Elicit Peripheral and Central Effects: State-of-the-Art and ShortGuidelines Based on Results from the Medical University of Graz, the German Academy of Acupuncture, and the Scientific LiteratureEvid Based Complement Alternat Med. 2012;2012:697096. doi:10.1155/2012/697096. Epub 2012 Apr.
    1. Zijlstra FJ, van den Berg-de Lange I, Huygen FJ, Klein J. Anti-inflammatory actions of acupuncture. Mediators Inflamm. 2003;12:59–69. doi: 10.1080/0962935031000114943.
    1. López CC, Martínez González JM, Donado Rodríguez M. Variations of interleukin-6 after surgical removal of lower third molars. Med Oral Patol Oral Cir Bucal. 2006;11:E520–6.
    1. Litscher G.Integrative laser medicine and high-tech acupuncture at the medical university of graz, austria, europe.Evid Based Complement Alternat Med. 2012;2012:103109. doi:10.1155/2012/103109. Epub 2012 Apr 17.
    1. Shang C. Prospective tests on biological models of acupuncture. Evid Based Complement Alternat Med. 2009;6:31–9. doi: 10.1093/ecam/nem122.
    1. Lao L, Bergman S, Hamilton GR, Langenberg P, Brman B. Evaluation of acupuncture for pain control after oral surgery—A placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 1999;125:567–72. doi: 10.1001/archotol.125.5.567.
    1. Round R, Litscher G, Bahr F. Auricular acupuncture with laser. Evid Based Complement Alternat Med. 2013;2013:984763. doi: 10.1155/2013/984763.
    1. Arai YC, Sakakima Y, Kawanishi J, Nishihara M, Ito A, Tawada Y, Maruyama Y.Auricular acupuncture at the "shenmen" and "point zero" points induced parasympathetic activation. Evid Based Complement Alternat Med. 2013;2013:945063. doi:10.1155/2013/945063. Epub 2013 Jun 4.
    1. Gori L, Firenzuoli F. Ear acupuncture in European traditional medicine. Evid Based Complement Alternat Med. 2007;4(Suppl 1):13–6. doi: 10.1093/ecam/nem106.
    1. Oleson T. Auriculotherapy manual—Chinese and Western systems of ear acupuncture. 4. London: Churchill Livingstone; 2014.
    1. World Health Organization. Report of the working group on auricular acupuncture nomenclature. Lyon, France, 1990. . Accessed 3 Jan 2016.
    1. King CE, Clelland JA, Knowles CJ, Jackson JR. Effect of helium-neon laser auriculotherapy on experimental pain threshold. Phys Ther. 1990;70(1):24–30.
    1. Lewis SM, Clelland JA, Knowles CJ, Jackson JR, Dimick AR. Effects of auricular acupuncture-like transcutaneous electric nerve stimulation on pain levels following wound care in patients with burns: a pilot study. J Burn Care Rehabil. 1990;11:322–9. doi: 10.1097/00004630-199007000-00010.
    1. Pell GJ, Gregory BT. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330–8.
    1. Peterson LJ. Princípios do tratamento de dentes impactados. In: Peterson LJ, Ellis E, Hupp JR, Tucker MR, editors. Cirurgia oral e maxilofacial contemporânea. 4. Rio de Janeiro: Mosby; 2005. pp. 197–226.
    1. Hu Y, Yang H, Wang P, Liu T, Tang W. Altered impedance of ear acupuncture point MT2 in breast cancer patients: a preliminary observation. Evid Based Complement Alternat Med. 2015;2015:909246.
    1. Wang L, Zhao B, Zhou L. Status and strategies analysis on international standardization of auricular acupuncture points. J Tradit Chin Med. 2013;15(33):408–12. doi: 10.1016/S0254-6272(13)60188-0.
    1. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117–26. doi: 10.1016/0304-3959(86)90228-9.
    1. Ustün Y, Erdogan O, Esen E, Karsli ED. Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003;96:535–9. doi: 10.1016/S1079-2104(03)00464-5.
    1. Bauer HC, Duarte FL, Horliana AC, Tortamano IC, Perez FE, Simone JL, Jorge WA. Assessment preemptive analgesia with ibuprofen coadministered or not with dexamethasone in third molar surgery: a randomized double-blind controlled clinical trial. Oral Maxillofacial Surg. 2013;17:165–71. doi: 10.1007/s10006-012-0360-7.
    1. Costa FW, Soares EC, Esses DF, Silva PG, Bezerra TP, Scarparo HC, Ribeiro TR, Fonteles CS. A split-mouth, randomized, triple-blind, placebo-controlled study to analyze the pre-emptive effect of etoricoxib 120 mg on inflammatory events following removal of unerupted mandibular third molars. Int J Oral Maxillofac Surg. 2015;44(9):1166–74. doi: 10.1016/j.ijom.2015.06.012.
    1. Lökken P, Olsen I, Bruaset I, Norman-Pedersen K. Bilateral surgical removal of impacted lower third molar teeth as a model for drug evaluation: a test with ibuprofen. Eur J Clin Pharmacol. 1975;4(8):209–16. doi: 10.1007/BF00567117.
    1. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, Schulz KF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030.
    1. Almendros-Marqués N, Berini-Aytés L, Gay-Escoda C. Evaluation of intraexaminer and interexaminer agreement on classifying lower third molars according to the systems of Pell and Gregory and of Winter. J Oral Maxillofac Surg. 2008;66:893–9.
    1. Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013;32:41–52.
    1. Schikora D. Laserneedles in acupuncture. In: Litscher G, Schikora D, editors. Laserneedle-acupuncture science and practice. Lengerich: Pabst Science; 2005. pp. 1–17.
    1. Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS. Is adjuvant laser therapy effective for preventing pain, swelling and trismus after surgical removal of impacted mandibular third molars? A systematic review and meta-analysis. J Oral Maxillofac Surg. 2012;70:1789–801. doi: 10.1016/j.joms.2012.01.008.
    1. Prady SL, Richmond SJ, Morton VM, Macpherson H. A systematic evaluation of the impact of STRICTA and CONSORT recommendations on quality of reporting for acupuncture trials. PLoS One. 2008;3:e1577. doi: 10.1371/journal.pone.0001577.
    1. Jones P, Dalziel SR, Lamdin R, Miles-Chan JL, Frampton C. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2015;7:CD007789.
    1. Aminoshariae A, Khan A. Acetaminophen: old drug, new issues. J Endod. 2015;41:588–93. doi: 10.1016/j.joen.2015.01.024.
    1. Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995;274:1870–3. doi: 10.1001/jama.1995.03530230056031.

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