Low Power Laser in Mandibular Third Molar Surgery

Low Power Laser in the Second Molar Tissue Repair and in the Postoperative of Mandibular Third Molar Surgery - Double Blind Randomized Clinical Trial.

The low-power laser provides the body with an improvement in the inflammatory response. Thus, the objective of this study is to evaluate two laser application protocols in 60 patients requiring surgical treatment for extraction of third molars included, without distinction of race or gender, aged between 16 and 40 years, coming from the Faculty of Dentistry Of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) , group 2 - intraoral irradiation with 660 nm laser at a dose of 30 J (30 mW, 30 J / cm 2) and group 3- control group, with application of placebo laser. At 3 and 7 days after surgery, the patients will be evaluated by two evaluators who will measure edema, trismus and pain. The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

Study Overview

• Status: Completed
• Conditions: Laser Therapy, Low-Level
• Intervention / Treatment: Radiation: Grupo II- Greater laser fluency; Radiation: Grupo III- Laser sham; Radiation: Grupo I- Lower laser fluency

Detailed Description

Knowing the ability of the low-power laser to provide the body with an improvement in inflammatory response, with consequent reduction of edema, minimizing painful symptoms and leading to biostimulation, laser therapy is presented as an alternative for processes that present an inflammatory reaction, Pain and need for tissue regeneration. The literature shows the efficacy of laser in the postoperative surgery for extraction of third molars. However, to date, there is no consensus on the best protocol to be used in these cases. Thus, the objective of this study will be to evaluate two laser application protocols. To this end, 60 patients will be selected who require surgical treatment for the extraction of third molars, regardless of race or gender, between the ages of 16 and 40, from the School of Dentistry of São José dos Campos (UNESP). These patients will be divided randomly into 3 groups: group 1 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2), group 2 - intraoral irradiation with 660 nm laser at a dose of 10 J (30 mW, 10 J / cm 2) and group 3 - control group, with application of placebo laser. At 3 and 7 days after surgery, patients will be evaluated by two evaluators who will measure edema, mouth opening (assessment of muscle spasm) and pain. To compare the data, we will use the analog pain scale (VAS), the method of Ustün et al. (2003), and the millimeter rule. The patient will also be questioned about possible postoperative problems, as well as the surgeon, who will classify the postoperative repair process according to Batinjan et al. (2013). The tissue repair will also be evaluated after 1, 3 and 6 months of surgery, through radiographic analysis and periodontal conditions in the distal of the lower second molar. The results will be submitted to descriptive statistics and compared using the statistical analysis of variance (ANOVA) and Tukey test with significance level of 5%.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy patients, without surgical contraindications, requiring avulsion of the included third molars and / or impacted lower molars,
• Teeth classified according to Winter (1926) as mesioangulated and according to Pell & Gregory (1933) as 1A to 2B.
• Between the ages of 16 and 40
• Who have agreed to participate in the research voluntarily, after knowing the risks and benefits, and signed the Informed Consent Term (TCLE)

Exclusion Criteria:

• Patients with any systemic or local change that contraindicate the procedure,
• Use of anti-inflammatories in the last 15 days,
• Patients smokers or diabetics.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Grupo I- Lower laser fluency; 20 patients received 660 nm red laser diode laser therapy, 30 mW power and 10 J / cm2 fluency, in the immediate period after surgical period of the third molar third molar extraction / impacted by the intraoral region	Radiation: Grupo II- Greater laser fluency; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Red laser diode of 660 nm/ power 30 mW/ creep of 30 J / cm2.; Radiation: Grupo III- Laser sham; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Control group, application of laser sham
Active Comparator: Grupo II- Greater laser fluency; 20 patients received 660 nm red laser diode laser therapy, 30 mW power and 30J / cm2 fluency, in the immediate period after surgical of the third molar third molar extraction / impacted by the intraoral region	Radiation: Grupo III- Laser sham; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Control group, application of laser sham; Radiation: Grupo I- Lower laser fluency; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Red laser diode of 660 nm/ power 30 mW/ creep of 10 J / cm2
Placebo Comparator: Grupo III- Laser sham; Application of laser sham, the handpiece of the device will be positioned intraorally and activated. However, the tip of the applicator will be covered by an opaque material that prevents radiation from passing through.	Radiation: Grupo II- Greater laser fluency; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Red laser diode of 660 nm/ power 30 mW/ creep of 30 J / cm2.; Radiation: Grupo I- Lower laser fluency; The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.; Other Names: Red laser diode of 660 nm/ power 30 mW/ creep of 10 J / cm2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal probing	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). For the investigator periodontal evaluation was performed based on the modified Montero & Mazzaglia (2011) methodology, where the length of the clinical crown in the second distal molar region will be measured with a North Carolina-type probe (Hu-Friedy, Chicago, USA). According to this methodology, we will previously mold the occlusal of the second molar with a condensation silicone (Optosil Xantopren, Heraeus Kulzer, Hanau, Germany), which was used as a guide to standardize the location and height of the measurement. We will then measure at three points in the distal of the second molar: disto-lingual, mesio-distal and vestibular-distal.	Initially carried out in one, three and six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham).The investigators were based on the analogue pain scale (VAS).	Evaluated immediately, two, four, six and eight hours after surgery. And with continuity for one, two, three and four days
Edema assessment	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). For investigators to measure facial edema used the method of Ustün et al. (2003) and a millimeter rule to obtain the measures.	Initially carried out in three and seven days.
Trismus assessment	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). To measure the buccal opening, the distance between the incisal edges of the maxillary and mandibular incisors, obtained with the patient sitting upright, will be evaluated by a millimeter ruler.	Initially carried out in three and seven days
Radiographic assessment	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). Radiographic evaluation will be performed using the methodology as recommended by Ogundipe et al. (2011), who performed periapical radiographs of the investigators region and classified the bone repair based on three variables: hard blade, bone density and trabecular pattern according to a specific table.	Assessment in one, three and six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue repair	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham).The surgeon through the methodology proposed by Batinjan et al. (2013), will classify four indirect variables.	Assessment in three days
Problems encountered after surgery	Evaluated in patients in groups I (Lower laser fluency), II (Greater laser fluency) and III (Laser sham). The patients evaluated indirectly through the methodology proposed by Batinjan et al. (2013) with the completion of three variables.	Assessment in four days

Collaborators and Investigators

• Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

General Publications

• Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gandara Rey JM, Garcia-Garcia A. Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007 May;65(5):979-83. doi: 10.1016/j.joms.2006.06.281.
• 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.
• Montero J, Mazzaglia G. Effect of removing an impacted mandibular third molar on the periodontal status of the mandibular second molar. J Oral Maxillofac Surg. 2011 Nov;69(11):2691-7. doi: 10.1016/j.joms.2011.06.205. Epub 2011 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2016
• Primary Completion (Actual): June 7, 2016
• Study Completion (Actual): December 6, 2016

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Third molar;; Third molar surgery;; Laser;; Tissue Repair.
• Other Study ID Numbers: 47325515.3.0000.0077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No