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Low Laser Light Therapy After Impacted Third Molar Removal

Primary Purpose

Trismus, Edema, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Extra-oral laser irradiation
Intra-oral laser irradiation
Extra-oral placebo
Intra-oral Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trismus focused on measuring laser, third molar, low laser, inflammatory response

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Maria Cristina Zindel DeboniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Extra-oral laser irradiation

Extra-oral placebo

Intra-oral laser irradiation

intra-oral placebo

Arm Description

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

Laser point will be placed in region without irradiation on.

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

Laser point will be placed in region without irradiation on.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Edema percentage
measurement of face parameters dimension pre and post operative
mouth aperture in millimeters
comparison between maximum mouth aperture pre and post operatively

Full Information

First Posted
November 8, 2015
Last Updated
May 10, 2016
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02602431
Brief Title
Low Laser Light Therapy After Impacted Third Molar Removal
Official Title
A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
30 healthy participants of both genders, with 18 to 35 years-of-age, with the necessity of inferior bilateral third molar removal will be selected. Inclusion criteria will consider the presence of upper central incisive and same surgical difficulty for third molar extraction. Participants that present chronic TMJ pain, neurological or psychiatric disorders, pericoronitis, anti-inflammatory or analgesic use for the last 15 days, bisphosphonates usage history at any time, tabagism, pregnancy or a family history of photosensitivity and hypersensibility to analgesics, anti-inflammatory or antibiotics will not be included. The surgical procedures will be randomized for the group to be assigned respecting the interval of one month between the surgeries. Intra-oral group (IO) will be that in whose participant will receive the LLLT (Photon Lase III DMC equipment) with 660 nm wavelength, 100 mW of power, 107J / cm2 of power density, during 30 seconds, positioning the tip of the laser device in straight contact with each of the four points in the surgical area: corresponding to the occlusal surface of the tooth surgically extracted, in the middle third of the lingual surface, point the middle third of the buccal surface and point retro molar triangle region. Each point will receive energy 3J (Et= 12J). The extra-oral group (EO) will receive phototherapy with the 808nm of wavelength following the same above protocol although positioning the laser point over the skin in straight contact with four points on the masseter muscle: next jaw insert, lower middle region, upper middle region near the insertion of the zygomatic arch. In the IO group the extra-oral region will not be irradiated (the laser tip will be put in place without energy) in the EO group it will be done the opposite, so as the same patient will be the control because the participant will not be capable to identify which group he belongs to. The same investigator will perform surgical procedures and laser therapy. All participants will receive the same postoperative medication. Three distances will evaluate the range of edema: from tragus to the corner of the mouth, from gonial angle to the corner of the mouth and from gonial angle to the corner of the eye using a malleable millimeter rule. Trismus will be evaluated by the maximum range of mouth opening considering the inter-incisal distance between the edges of upper and lower right central incisors by a caliper in three moments: before surgery, 24 hours and 8 days after surgery. Participants will be asked to fill in a diary to assess the severity of postoperative pain on a visual analogue pain scale after the end of anesthetic effect: 4, 6, 8, 24, 48 hours postoperatively. The amount and time of medication will be also recorded. The quality of wound repair will be evaluated by two blinded calibrated observers, 24 hours and 8 days postoperatively in score from 0 to 3. The data will be submitted to appropriate statistical analysis for non-parametric samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus, Edema, Pain
Keywords
laser, third molar, low laser, inflammatory response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extra-oral laser irradiation
Arm Type
Active Comparator
Arm Description
infra-red wave laser, 660nm, 100mW, and 107J/cm2
Arm Title
Extra-oral placebo
Arm Type
Placebo Comparator
Arm Description
Laser point will be placed in region without irradiation on.
Arm Title
Intra-oral laser irradiation
Arm Type
Active Comparator
Arm Description
red wave laser, 660nm, 100mW, and 107J/cm2
Arm Title
intra-oral placebo
Arm Type
Placebo Comparator
Arm Description
Laser point will be placed in region without irradiation on.
Intervention Type
Device
Intervention Name(s)
Extra-oral laser irradiation
Other Intervention Name(s)
DMC Photon Laser III
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Intra-oral laser irradiation
Other Intervention Name(s)
DMC Photn Laser III
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Extra-oral placebo
Other Intervention Name(s)
DMC Photn Laser III
Intervention Description
Laser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on
Intervention Type
Device
Intervention Name(s)
Intra-oral Placebo
Other Intervention Name(s)
DMC Photn Laser III
Intervention Description
Laser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on
Primary Outcome Measure Information:
Title
Change in Pain Scores on the Visual Analog scale
Description
measurements in a diary after anesthetic sensation had stopped and 4, 6, 8, 24, 48hours post operatively
Time Frame
4, 6, 8, 24, 48hours post operative period
Secondary Outcome Measure Information:
Title
Edema percentage
Description
measurement of face parameters dimension pre and post operative
Time Frame
24 hours after surgery
Title
mouth aperture in millimeters
Description
comparison between maximum mouth aperture pre and post operatively
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: necessity of bilateral impacted third molar removal with similar dental arch positioning and similar surgical difficulty. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Cristina Deboni, PhD
Phone
11.55 28488185
Email
mczdebon@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Vinicius PA Santos, Undergraduate
Phone
11. 55. 28488185
Email
vinicius.paes.santos@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Deboni, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cristina Zindel Deboni
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Deboni, PhD
Phone
+5511984269925
Email
mczdebon@usp.br
First Name & Middle Initial & Last Name & Degree
Vinicius Paes Assis dos Santos, Trainee

12. IPD Sharing Statement

Citations:
PubMed Identifier
20006153
Citation
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Results Reference
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PubMed Identifier
18088865
Citation
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.
Results Reference
background
PubMed Identifier
17157479
Citation
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.
Results Reference
background
PubMed Identifier
19484402
Citation
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.
Results Reference
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PubMed Identifier
22398186
Citation
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.
Results Reference
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PubMed Identifier
25098769
Citation
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Results Reference
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PubMed Identifier
23494104
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
22843310
Citation
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Citation
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Results Reference
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Low Laser Light Therapy After Impacted Third Molar Removal

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