Low Laser Light Therapy After Impacted Third Molar Removal

May 10, 2016 updated by: Maria Cristina Zindel Deboni, University of Sao Paulo

A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. corresponding to the occlusal surface of the tooth surgically extracted,
  2. in the middle third of the lingual surface, point
  3. the middle third of the buccal surface and point
  4. 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:

  1. next jaw insert,
  2. lower middle region,
  3. upper middle region
  4. 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-000
        • Recruiting
        • Maria Cristina Zindel Deboni
        • Contact:
          • Maria Cristina Deboni, PhD
          • Phone Number: +5511984269925
          • Email: mczdebon@usp.br
        • Sub-Investigator:
          • Vinicius Paes Assis dos Santos, Trainee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extra-oral laser irradiation
infra-red wave laser, 660nm, 100mW, and 107J/cm2
Device: Extra-oral laser irradiation
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
Other Names:
  • DMC Photon Laser III
Placebo Comparator: Extra-oral placebo
Laser point will be placed in region without irradiation on.
Device: Extra-oral placebo
Laser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on
Other Names:
  • DMC Photn Laser III
Active Comparator: Intra-oral laser irradiation
red wave laser, 660nm, 100mW, and 107J/cm2
Device: Intra-oral laser irradiation
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
Other Names:
  • DMC Photn Laser III
Placebo Comparator: intra-oral placebo
Laser point will be placed in region without irradiation on.
Device: Intra-oral Placebo
Laser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on
Other Names:
  • DMC Photn Laser III

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Scores on the Visual Analog scale
Time Frame: 4, 6, 8, 24, 48hours post operative period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema percentage
Time Frame: 24 hours after surgery
measurement of face parameters dimension pre and post operative
24 hours after surgery
mouth aperture in millimeters
Time Frame: 24 hours after surgery
comparison between maximum mouth aperture pre and post operatively
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Maria Cristina Deboni, PhD, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31861414.4.0000.0075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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