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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2016

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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.
Appendix
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Literature
1.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
2.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
3.
go back to reference 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.CrossRef 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.CrossRef
4.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
5.
go back to reference Fragyscos FD. Perioperative and post-operative complications in oral surgery. Berlin: Heidelberg: Springer-Verlag;2010. ISBN 3642064310, 9783642064319. Fragyscos FD. Perioperative and post-operative complications in oral surgery. Berlin: Heidelberg: Springer-Verlag;2010. ISBN 3642064310, 9783642064319.
6.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
7.
go back to reference 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. 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.
8.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
9.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
10.
go back to reference Rabischong P, Terral C. Scientific basis of auriculotherapy: state of the art. Med Acupunct. 2014;26:84–96. Rabischong P, Terral C. Scientific basis of auriculotherapy: state of the art. Med Acupunct. 2014;26:84–96.
11.
go back to reference 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. 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.
12.
go back to reference 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. 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.
14.
go back to reference 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. 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.
15.
go back to reference 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. 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.
16.
go back to reference Shang C. Prospective tests on biological models of acupuncture. Evid Based Complement Alternat Med. 2009;6:31–9.CrossRefPubMed Shang C. Prospective tests on biological models of acupuncture. Evid Based Complement Alternat Med. 2009;6:31–9.CrossRefPubMed
17.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
19.
go back to reference 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. 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.
21.
go back to reference Oleson T. Auriculotherapy manual—Chinese and Western systems of ear acupuncture. 4th ed. London: Churchill Livingstone; 2014. Oleson T. Auriculotherapy manual—Chinese and Western systems of ear acupuncture. 4th ed. London: Churchill Livingstone; 2014.
23.
go back to reference 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.PubMed 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.PubMed
24.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
25.
go back to reference Pell GJ, Gregory BT. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330–8. Pell GJ, Gregory BT. Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933;39:330–8.
26.
go back to reference Peterson LJ. Princípios do tratamento de dentes impactados. In: Peterson LJ, Ellis E, Hupp JR, Tucker MR, editors. Cirurgia oral e maxilofacial contemporânea. 4th ed. Rio de Janeiro: Mosby; 2005. p. 197–226. Peterson LJ. Princípios do tratamento de dentes impactados. In: Peterson LJ, Ellis E, Hupp JR, Tucker MR, editors. Cirurgia oral e maxilofacial contemporânea. 4th ed. Rio de Janeiro: Mosby; 2005. p. 197–226.
27.
go back to reference 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. 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.
28.
go back to reference 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.CrossRef 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.CrossRef
29.
go back to reference Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117–26.CrossRefPubMed Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117–26.CrossRefPubMed
30.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
31.
go back to reference 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.CrossRef 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.CrossRef
32.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
33.
go back to reference 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.CrossRef 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.CrossRef
34.
go back to reference 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.PubMed 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.PubMed
35.
go back to reference 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. 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.
36.
go back to reference 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.PubMedPubMedCentral 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.PubMedPubMedCentral
37.
go back to reference Schikora D. Laserneedles in acupuncture. In: Litscher G, Schikora D, editors. Laserneedle-acupuncture science and practice. Lengerich: Pabst Science; 2005. p. 1–17. Schikora D. Laserneedles in acupuncture. In: Litscher G, Schikora D, editors. Laserneedle-acupuncture science and practice. Lengerich: Pabst Science; 2005. p. 1–17.
38.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
39.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
40.
go back to reference 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. 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.
41.
42.
go back to reference Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995;274:1870–3.CrossRefPubMed Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995;274:1870–3.CrossRefPubMed
Metadata
Title
Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial
Authors
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
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1540-9

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