Low Laser Light Therapy After Impacted Third Molar Removal

NCT02602431 | Unknown

• 1 other identifier: 31861414.4.0000.0075
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Third molars extraction is a surgery frequently performed in dentistry. It is generally associated to a great postoperative distress rendered by pain, swelling and trismus, caused by surgical trauma inflammation. Several methods have been proposed to prevent these complications and to increase tissue repair quality. The use of low level laser therapy (LLLT) has been reported in dentistry since 1970. A large number of studies have reported the benefits of LLLT without collateral damage, positive effect as an anti-inflammatory agent and benefits in accelerating wound repair. However, some clinical applications strategies have been contradictories in everyday practice with results not always equivalent. Objective: To verify if a single LLLT intra or extra oral application, singly, are analogous in their effects in controlling postoperative edema, trismus, pain and wound repair in third molar surgery.

Conditions

Trismus; Edema; Pain

Keywords

laser; third molar; low laser; inflammatory response

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores on the Visual Analog scale

  measurements in a diary after anesthetic sensation had stopped and 4, 6, 8, 24, 48hours post operatively

  4, 6, 8, 24, 48hours post operative period

Secondary Outcomes (2)

• Edema percentage

  24 hours after surgery

• mouth aperture in millimeters

  24 hours after surgery

Study Arms (4)

Extra-oral laser irradiation

ACTIVE COMPARATOR

infra-red wave laser, 660nm, 100mW, and 107J/cm2

Device: Extra-oral laser irradiation

Extra-oral placebo

PLACEBO COMPARATOR

Laser point will be placed in region without irradiation on.

Device: Extra-oral placebo

Intra-oral laser irradiation

ACTIVE COMPARATOR

red wave laser, 660nm, 100mW, and 107J/cm2

Device: Intra-oral laser irradiation

intra-oral placebo

PLACEBO COMPARATOR

Laser point will be placed in region without irradiation on.

Device: Intra-oral Placebo

Interventions

Extra-oral laser irradiation DEVICE

Irradiation will be employed extra oral by infra-red wave laser, 660nm, 100mW, and 107J/cm2 in four points of Masseter muscle for 30 seconds in each

Also known as: DMC Photon Laser III

Extra-oral laser irradiation

Intra-oral laser irradiation DEVICE

Irradiation will be employed intra oral by red wave laser, 660nm, 100mW, and 107J/cm2 in four points for 30 seconds in each : 1. Superficial face of dental socket, 2. Lingual face; 3. buccal face and 4. Retromolar region

Also known as: DMC Photn Laser III

Intra-oral laser irradiation

Extra-oral placebo DEVICE

Laser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on

Also known as: DMC Photn Laser III

Extra-oral placebo

Intra-oral Placebo DEVICE

Laser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on

Also known as: DMC Photn Laser III

intra-oral placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• necessity of bilateral impacted third molar removal with similar dental arch positioning and similar surgical difficulty.

You may not qualify if:

• Compromised Systemic Health status, Neurologic and/or mental disorders, local infection history, anti-inflammatory or analgesic use for the last 15 days, tabagism, ethylism, pregnancy.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Maria Cristina Zindel Deboni

São Paulo, São Paulo, 05508-000, Brazil

RECRUITING

Related Publications (10)

• Larrazabal C, Garcia B, Penarrocha M, Penarrocha M. Influence of oral hygiene and smoking on pain and swelling after surgical extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2010 Jan;68(1):43-6. doi: 10.1016/j.joms.2009.07.061.

  PMID: 20006153 BACKGROUND

• Mehrabi M, Allen JM, Roser SM. Therapeutic agents in perioperative third molar surgical procedures. Oral Maxillofac Surg Clin North Am. 2007 Feb;19(1):69-84, vi. doi: 10.1016/j.coms.2006.11.010.

  PMID: 18088865 BACKGROUND

• Markovic A, Todorovic Lj. Effectiveness of dexamethasone and low-power laser in minimizing oedema after third molar surgery: a clinical trial. Int J Oral Maxillofac Surg. 2007 Mar;36(3):226-9. doi: 10.1016/j.ijom.2006.10.006. Epub 2006 Dec 8.

  PMID: 17157479 BACKGROUND

• Aras MH, Gungormus 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 Sep;25(5):641-5. doi: 10.1007/s10103-009-0684-1. Epub 2009 May 31.

  PMID: 19484402 BACKGROUND

• 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 Aug;70(8):1789-801. doi: 10.1016/j.joms.2012.01.008. Epub 2012 Mar 6.

  PMID: 22398186 BACKGROUND

• He WL, Yu FY, Li CJ, Pan J, Zhuang R, Duan 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 Aug;30(6):1779-88. doi: 10.1007/s10103-014-1634-0. Epub 2014 Aug 7.

  PMID: 25098769 BACKGROUND

• Kazancioglu HO, Ezirganli S, Demirtas N. Comparison of the influence of ozone and laser therapies on pain, swelling, and trismus following impacted third-molar surgery. Lasers Med Sci. 2014 Jul;29(4):1313-9. doi: 10.1007/s10103-013-1300-y. Epub 2013 Mar 14.

  PMID: 23494104 BACKGROUND

• Lopez-Ramirez M, Vilchez-Perez MA, Gargallo-Albiol J, Arnabat-Dominguez J, Gay-Escoda C. Efficacy of low-level laser therapy in the management of pain, facial swelling, and postoperative trismus after a lower third molar extraction. A preliminary study. Lasers Med Sci. 2012 May;27(3):559-66. doi: 10.1007/s10103-011-0936-8. Epub 2011 May 27.

  PMID: 21617973 BACKGROUND

• 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 May;28(3):845-9. doi: 10.1007/s10103-012-1174-4. Epub 2012 Jul 28.

  PMID: 22843310 BACKGROUND

• Pallotta RC, Bjordal JM, Frigo L, Leal Junior EC, Teixeira S, Marcos RL, Ramos L, Messias Fde M, Lopes-Martins RA. Infrared (810-nm) low-level laser therapy on rat experimental knee inflammation. Lasers Med Sci. 2012 Jan;27(1):71-8. doi: 10.1007/s10103-011-0906-1. Epub 2011 Apr 12.

  PMID: 21484455 BACKGROUND

MeSH Terms

Conditions

Trismus; Edema; Pain

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Cristina Deboni, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Deboni, PhD

CONTACT

11.55 28488185; mczdebon@usp.br

Vinicius PA Santos, Undergraduate

CONTACT

11. 55. 28488185; vinicius.paes.santos@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: November 11, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

BR (1)