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Low Laser Light Therapy After Impacted Third Molar Removal

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ClinicalTrials.gov Identifier: NCT02602431
Recruitment Status : Unknown
Verified May 2016 by Maria Cristina Zindel Deboni, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Maria Cristina Zindel Deboni, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Trismus Edema Pain Device: Extra-oral laser irradiation Device: Intra-oral laser irradiation Device: Extra-oral placebo Device: Intra-oral Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Unique Application of Low Laser Therapy After Third Molar Surgery: A Randomized Controlled Clinical Trial
Study Start Date : March 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

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 Name: 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 Name: 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 Name: 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 Name: DMC Photn Laser III




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Edema percentage [ Time Frame: 24 hours after surgery ]
    measurement of face parameters dimension pre and post operative

  2. mouth aperture in millimeters [ Time Frame: 24 hours after surgery ]
    comparison between maximum mouth aperture pre and post operatively



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602431


Contacts
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Contact: Maria Cristina Deboni, PhD 11.55 28488185 mczdebon@usp.br
Contact: Vinicius PA Santos, Undergraduate 11. 55. 28488185 vinicius.paes.santos@usp.br

Locations
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Brazil
Maria Cristina Zindel Deboni Recruiting
São Paulo, Brazil, 05508-000
Contact: Maria Cristina Deboni, PhD    +5511984269925    mczdebon@usp.br   
Sub-Investigator: Vinicius Paes Assis dos Santos, Trainee         
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Maria Cristina Deboni, PhD Associate Professor

Publications:

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Responsible Party: Maria Cristina Zindel Deboni, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02602431     History of Changes
Other Study ID Numbers: 31861414.4.0000.0075
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Maria Cristina Zindel Deboni, University of Sao Paulo:
laser
third molar
low laser
inflammatory response
Additional relevant MeSH terms:
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Trismus
Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms