Skip to main content
Top
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Simone Oliveira Sierra, Alessandro Melo Deana, Raquel Agnelli Mesquita Ferrari, Priscilla Maia Albarello, Sandra Kalil Bussadori, Kristianne Porta Santos Fernandes

Published in: Trials | Issue 1/2013

Login to get access

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).
Appendix
Available only for authorised users
Literature
1.
go back to reference Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS: Is Adjuvant laser therapy is 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: 1789-1801. 10.1016/j.joms.2012.01.008.CrossRefPubMed Brignardello-Petersen R, Carrasco-Labra A, Araya I, Yanine N, Beyene J, Shah PS: Is Adjuvant laser therapy is 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: 1789-1801. 10.1016/j.joms.2012.01.008.CrossRefPubMed
2.
go back to reference Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD: The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004, 22: 323-329. 10.1089/pho.2004.22.323.CrossRefPubMed Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD: The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004, 22: 323-329. 10.1089/pho.2004.22.323.CrossRefPubMed
3.
go back to reference Bjordal JM, Johnson MI, Iversen V, Aimbire F, Lopes-Martins RA: Low-level laser therapy in acute pain: a systematic review of possible mechanisms of action and clinical effects in randomized placebo-controlled trials. Photomed Laser Surg. 2006, 24: 158-168. 10.1089/pho.2006.24.158.CrossRefPubMed Bjordal JM, Johnson MI, Iversen V, Aimbire F, Lopes-Martins RA: Low-level laser therapy in acute pain: a systematic review of possible mechanisms of action and clinical effects in randomized placebo-controlled trials. Photomed Laser Surg. 2006, 24: 158-168. 10.1089/pho.2006.24.158.CrossRefPubMed
4.
go back to reference Honmura A, Yanase M, Obata J, Haruki E: Therapeutic effect of Ga-Al-As diode laser irradiation on experimentally induced inflammation in rats. Lasers Surg Med. 1992, 12: 441-449. 10.1002/lsm.1900120414.CrossRefPubMed Honmura A, Yanase M, Obata J, Haruki E: Therapeutic effect of Ga-Al-As diode laser irradiation on experimentally induced inflammation in rats. Lasers Surg Med. 1992, 12: 441-449. 10.1002/lsm.1900120414.CrossRefPubMed
5.
go back to reference Lievens PC: The effect of the combined HeNe laser and IR treatment on the regeneration of the lymphatic system during the process of wound healing. Lasers Med Sci. 1991, 6: 193-199. 10.1007/BF02032548.CrossRef Lievens PC: The effect of the combined HeNe laser and IR treatment on the regeneration of the lymphatic system during the process of wound healing. Lasers Med Sci. 1991, 6: 193-199. 10.1007/BF02032548.CrossRef
6.
go back to reference Albertini R, Villaverde AB, Aimbire F, Salgado MA, Bjordal JM, Alves LP, Munin E, Costa MS: Anti-inflammatory effects of low-level laser therapy (LLLT) with two different red wavelengths (660 nm and 684 nm) in carrageenan-induced rat paw edema. J Photochem Photobiol. 2001, 89: 50-55.CrossRef Albertini R, Villaverde AB, Aimbire F, Salgado MA, Bjordal JM, Alves LP, Munin E, Costa MS: Anti-inflammatory effects of low-level laser therapy (LLLT) with two different red wavelengths (660 nm and 684 nm) in carrageenan-induced rat paw edema. J Photochem Photobiol. 2001, 89: 50-55.CrossRef
7.
go back to reference Baptista J, Martins MD, Pavesi VC, Bussadori SK, Fernandes KP, Pinto Júnior D Dos S, Ferrari RA: Influence of laser photobiomodulation During IV collagen on skeletal muscle tissue remodeling after injury in rats. Photomed Laser Surg. 2011, 29: 11-17. 10.1089/pho.2009.2737.CrossRefPubMed Baptista J, Martins MD, Pavesi VC, Bussadori SK, Fernandes KP, Pinto Júnior D Dos S, Ferrari RA: Influence of laser photobiomodulation During IV collagen on skeletal muscle tissue remodeling after injury in rats. Photomed Laser Surg. 2011, 29: 11-17. 10.1089/pho.2009.2737.CrossRefPubMed
8.
go back to reference Oron U: Photoengineering of tissue repair in skeletal and cardiac muscles. Photomed Laser Surg. 2006, 24: 111-120. 10.1089/pho.2006.24.111.CrossRefPubMed Oron U: Photoengineering of tissue repair in skeletal and cardiac muscles. Photomed Laser Surg. 2006, 24: 111-120. 10.1089/pho.2006.24.111.CrossRefPubMed
9.
go back to reference Mesquita-Ferrari RA, Martins MD, Silva JA, da Silva TD, Piovesan RF, Pavesi VC, Bussadori SK, Fernandes KP: Effects of low-level laser therapy on expression of TNF-α and TGF-β in skeletal muscle during the repair process. Lasers Med Sci. 2011, 26: 335-340. 10.1007/s10103-010-0850-5.CrossRefPubMed Mesquita-Ferrari RA, Martins MD, Silva JA, da Silva TD, Piovesan RF, Pavesi VC, Bussadori SK, Fernandes KP: Effects of low-level laser therapy on expression of TNF-α and TGF-β in skeletal muscle during the repair process. Lasers Med Sci. 2011, 26: 335-340. 10.1007/s10103-010-0850-5.CrossRefPubMed
10.
go back to reference de Souza TO, Mesquita DA, Ferrari RA, Dos Santos Pinto D, Correa L, Bussadori SK, Fernandes KP, Martins MD: Phototherapy with low-level laser affects the remodeling of types I and III collagen in skeletal muscle repair. Lasers Med Sci. 2011, 26: 803-814. 10.1007/s10103-011-0951-9.CrossRefPubMed de Souza TO, Mesquita DA, Ferrari RA, Dos Santos Pinto D, Correa L, Bussadori SK, Fernandes KP, Martins MD: Phototherapy with low-level laser affects the remodeling of types I and III collagen in skeletal muscle repair. Lasers Med Sci. 2011, 26: 803-814. 10.1007/s10103-011-0951-9.CrossRefPubMed
11.
go back to reference López-Ramírez M, Vílchez-Pérez MA, Gargallo-Albiol J, Arnabat-Domínguez J, Gay-Escoda C: Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after third molar extraction to lower. A preliminary study. Lasers Med Sci. 2012, 27: 559-566. 10.1007/s10103-011-0936-8.CrossRefPubMed López-Ramírez M, Vílchez-Pérez MA, Gargallo-Albiol J, Arnabat-Domínguez J, Gay-Escoda C: Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after third molar extraction to lower. A preliminary study. Lasers Med Sci. 2012, 27: 559-566. 10.1007/s10103-011-0936-8.CrossRefPubMed
12.
go back to reference Røynesdal AK, Björnland T, Barkvoll P, Haanaes HR: The effect of soft-laser application on postoperative pain and swelling. A double-blind, crossover study. Int J Oral Maxillofac Surg. 1993, 22: 242-245. 10.1016/S0901-5027(05)80646-0.CrossRefPubMed Røynesdal AK, Björnland T, Barkvoll P, Haanaes HR: The effect of soft-laser application on postoperative pain and swelling. A double-blind, crossover study. Int J Oral Maxillofac Surg. 1993, 22: 242-245. 10.1016/S0901-5027(05)80646-0.CrossRefPubMed
13.
go back to reference Aras MH, Güngörmüs M: The effect of low-level laser therapy on trismus and facial swelling following surgical extraction of the lower third molar. Photomed Laser Surg. 2009, 27: 21-24. 10.1089/pho.2008.2258.CrossRefPubMed Aras MH, Güngörmüs M: The effect of low-level laser therapy on trismus and facial swelling following surgical extraction of the lower third molar. Photomed Laser Surg. 2009, 27: 21-24. 10.1089/pho.2008.2258.CrossRefPubMed
14.
go back to reference Aras MH, Güngörmüş M: 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 molar. Lasers Med Sci. 2010, 25: 641-645. 10.1007/s10103-009-0684-1.CrossRefPubMed Aras MH, Güngörmüş M: 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 molar. Lasers Med Sci. 2010, 25: 641-645. 10.1007/s10103-009-0684-1.CrossRefPubMed
15.
go back to reference Amarillas-Escobar ED, Toranzo-Fernández JM, Martínez-Rider R, Noyola-Frías MA, Hidalgo-Hurtado JA, Serna VM, Gordillo-Moscoso A, Pozos-Guillén AJ: Use of laser therapy after surgical removal of lower third molars impacted. J Oral Maxillofac Surg. 2010, 68: 319-324. 10.1016/j.joms.2009.07.037.CrossRefPubMed Amarillas-Escobar ED, Toranzo-Fernández JM, Martínez-Rider R, Noyola-Frías MA, Hidalgo-Hurtado JA, Serna VM, Gordillo-Moscoso A, Pozos-Guillén AJ: Use of laser therapy after surgical removal of lower third molars impacted. J Oral Maxillofac Surg. 2010, 68: 319-324. 10.1016/j.joms.2009.07.037.CrossRefPubMed
16.
go back to reference Carrillo JS, Calatayud J, Manso FJ, Barberia E, Martinez JM, Donado M: A randomized double-blind clinical trial on the effectiveness of helium-neon laser in the prevention of pain, swelling and trismus after removal of impacted third molars. Int Dent J. 1990, 40: 31-36.PubMed Carrillo JS, Calatayud J, Manso FJ, Barberia E, Martinez JM, Donado M: A randomized double-blind clinical trial on the effectiveness of helium-neon laser in the prevention of pain, swelling and trismus after removal of impacted third molars. Int Dent J. 1990, 40: 31-36.PubMed
17.
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: 845-849. 10.1007/s10103-012-1174-4.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: 845-849. 10.1007/s10103-012-1174-4.CrossRefPubMed
18.
go back to reference Lago-Méndez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gándara Rey JM, García-García A: Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007, 65: 979-983. 10.1016/j.joms.2006.06.281.CrossRefPubMed Lago-Méndez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gándara Rey JM, García-García A: Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007, 65: 979-983. 10.1016/j.joms.2006.06.281.CrossRefPubMed
19.
go back to reference Troullos ES, Hargreaves KM, Butler DP, Dionne R: Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990, 48: 945-952. 10.1016/0278-2391(90)90007-O.CrossRefPubMed Troullos ES, Hargreaves KM, Butler DP, Dionne R: Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990, 48: 945-952. 10.1016/0278-2391(90)90007-O.CrossRefPubMed
20.
go back to reference Marković AB, Todorović 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 Radiol Endod. 2006, 102: 4-8.CrossRef Marković AB, Todorović 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 Radiol Endod. 2006, 102: 4-8.CrossRef
21.
go back to reference Clokie C, Bentley KC, Head TW: The effects of the helium-neon laser on postsurgical discomfort. A pilot study. J Can Dent Assoc. 1991, 57: 584-586.PubMed Clokie C, Bentley KC, Head TW: The effects of the helium-neon laser on postsurgical discomfort. A pilot study. J Can Dent Assoc. 1991, 57: 584-586.PubMed
22.
go back to reference Fernando S, Hill CM, Walker R: A randomized double blind comparative study of low level laser therapy following surgical extraction of lower third molar teeth. Br J Oral Maxillofac Surg. 1993, 31: 170-172. 10.1016/0266-4356(93)90118-G.CrossRefPubMed Fernando S, Hill CM, Walker R: A randomized double blind comparative study of low level laser therapy following surgical extraction of lower third molar teeth. Br J Oral Maxillofac Surg. 1993, 31: 170-172. 10.1016/0266-4356(93)90118-G.CrossRefPubMed
23.
go back to reference Markovic AB, Todorovic L: Effectiveness of dexamethasone and low-power laser in minimizing edema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007, 36: 226-229. 10.1016/j.ijom.2006.10.006.CrossRefPubMed Markovic AB, Todorovic L: Effectiveness of dexamethasone and low-power laser in minimizing edema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007, 36: 226-229. 10.1016/j.ijom.2006.10.006.CrossRefPubMed
24.
go back to reference Winter GB: Principles of the exodontia applied to the impacted mandibular third molar. 1926, St. Louis, Mo: American Medical Book Company Winter GB: Principles of the exodontia applied to the impacted mandibular third molar. 1926, St. Louis, Mo: American Medical Book Company
25.
go back to reference Pell GJ, Gregory BT: Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933, 39: 330-338. Pell GJ, Gregory BT: Impacted mandibular third molars: classification and modified techniques for removal. Dent Digest. 1933, 39: 330-338.
26.
go back to reference Larrazábal C, García B, Peñarrocha M, Peñarrocha M: Influence of oral hygiene and smoking on pain and swelling after surgical extraction of mandibular third molars impacted. J Oral Maxillofac Surg. 2010, 68: 43-46. 10.1016/j.joms.2009.07.061.CrossRefPubMed Larrazábal C, García B, Peñarrocha M, Peñarrocha M: Influence of oral hygiene and smoking on pain and swelling after surgical extraction of mandibular third molars impacted. J Oral Maxillofac Surg. 2010, 68: 43-46. 10.1016/j.joms.2009.07.061.CrossRefPubMed
27.
go back to reference Berge T, Boe OE: Predictor evaluation of postoperative morbidity after surgical removal of mandibular third molars. Acta Odontol Scand. 1994, 52: 162-169. 10.3109/00016359409027591.CrossRefPubMed Berge T, Boe OE: Predictor evaluation of postoperative morbidity after surgical removal of mandibular third molars. Acta Odontol Scand. 1994, 52: 162-169. 10.3109/00016359409027591.CrossRefPubMed
28.
go back to reference Bjørnsson GA, Haanaes HR, Skoglund LA: A randomized, double-blind crossover trial of paracetamol 1000 mg four times daily vs ibuprofen 600 mg: effect on swelling and other postoperative events after third molar surgery. Br J Clin Pharmacol. 2003, 55: 405-412. 10.1046/j.1365-2125.2003.01779.x.CrossRefPubMedPubMedCentral Bjørnsson GA, Haanaes HR, Skoglund LA: A randomized, double-blind crossover trial of paracetamol 1000 mg four times daily vs ibuprofen 600 mg: effect on swelling and other postoperative events after third molar surgery. Br J Clin Pharmacol. 2003, 55: 405-412. 10.1046/j.1365-2125.2003.01779.x.CrossRefPubMedPubMedCentral
29.
go back to reference Colorado-Bonnin M, Valmeseda-Castellón E, Berini-Aytés L, Gay-Escoda C: Quality of life following lower third molar removal. J Oral Maxillofac Surg. 2006, 35: 343-347. 10.1016/j.ijom.2005.08.008.CrossRef Colorado-Bonnin M, Valmeseda-Castellón E, Berini-Aytés L, Gay-Escoda C: Quality of life following lower third molar removal. J Oral Maxillofac Surg. 2006, 35: 343-347. 10.1016/j.ijom.2005.08.008.CrossRef
30.
go back to reference Baqain ZH, Abu Karaky A, Khraisat A, Duabis R, Sawair F, Rajab LD: Frequency estimates and risk factors for postoperative morbidity after third molar removal: a prospective cohort study. J Oral Maxillofac Surg. 2008, 66: 2276-2283. 10.1016/j.joms.2008.06.047.CrossRefPubMed Baqain ZH, Abu Karaky A, Khraisat A, Duabis R, Sawair F, Rajab LD: Frequency estimates and risk factors for postoperative morbidity after third molar removal: a prospective cohort study. J Oral Maxillofac Surg. 2008, 66: 2276-2283. 10.1016/j.joms.2008.06.047.CrossRefPubMed
31.
go back to reference Sato FR, Asprino L, De Araujo DE, De Moraes M: Short-term outcome of postoperative patient recovery perception after surgical removal of third molars. J Oral Maxillofac Surg. 2009, 67: 1083-1091. 10.1016/j.joms.2008.09.032.CrossRefPubMed Sato FR, Asprino L, De Araujo DE, De Moraes M: Short-term outcome of postoperative patient recovery perception after surgical removal of third molars. J Oral Maxillofac Surg. 2009, 67: 1083-1091. 10.1016/j.joms.2008.09.032.CrossRefPubMed
32.
go back to reference Bello SA, Adeyemo WL, Bamgbose BO, Obi EV, Adeyinka AA: Effect of age, impaction types and operative time on inflammatory tissue reactions following lower third molar surgery. Head Face Med. 2011, 28: 7-8. Bello SA, Adeyemo WL, Bamgbose BO, Obi EV, Adeyinka AA: Effect of age, impaction types and operative time on inflammatory tissue reactions following lower third molar surgery. Head Face Med. 2011, 28: 7-8.
33.
go back to reference Negreiros RM, Biazevic MG, Jorge WA, Michel-Crosato E: Relationship between oral health-related quality of life and the position of the lower third molar: postoperative follow-up. J Oral Maxillofac Surg. 2012, 70: 779-786. 10.1016/j.joms.2011.09.034.CrossRefPubMed Negreiros RM, Biazevic MG, Jorge WA, Michel-Crosato E: Relationship between oral health-related quality of life and the position of the lower third molar: postoperative follow-up. J Oral Maxillofac Surg. 2012, 70: 779-786. 10.1016/j.joms.2011.09.034.CrossRefPubMed
34.
go back to reference Savin J, Ogden GR: Third molar surgery–a preliminary report on aspects affecting quality of life in the early postoperative period. Br J Oral Maxillofac Surg. 1997, 35: 246-253. 10.1016/S0266-4356(97)90042-5.CrossRefPubMed Savin J, Ogden GR: Third molar surgery–a preliminary report on aspects affecting quality of life in the early postoperative period. Br J Oral Maxillofac Surg. 1997, 35: 246-253. 10.1016/S0266-4356(97)90042-5.CrossRefPubMed
35.
go back to reference McGrath C, Comfort MB, LO EC, Luo Y: Changes in life quality following third molar surgery--the immediate postoperative period. Br Dent J. 2003, 194: 265-268. 10.1038/sj.bdj.4809930.CrossRefPubMed McGrath C, Comfort MB, LO EC, Luo Y: Changes in life quality following third molar surgery--the immediate postoperative period. Br Dent J. 2003, 194: 265-268. 10.1038/sj.bdj.4809930.CrossRefPubMed
36.
go back to reference Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Creminelli L, Santoro F: Assessing molar third postoperative discomfort after surgery: a prospective study. J Oral Maxillofac Surg. 2007, 65: 901-907. 10.1016/j.joms.2005.12.046.CrossRefPubMed Grossi GB, Maiorana C, Garramone RA, Borgonovo A, Creminelli L, Santoro F: Assessing molar third postoperative discomfort after surgery: a prospective study. J Oral Maxillofac Surg. 2007, 65: 901-907. 10.1016/j.joms.2005.12.046.CrossRefPubMed
Metadata
Title
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
Authors
Simone Oliveira Sierra
Alessandro Melo Deana
Raquel Agnelli Mesquita Ferrari
Priscilla Maia Albarello
Sandra Kalil Bussadori
Kristianne Porta Santos Fernandes
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-373

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue