Clinical trial NCT03164252: Low Power Laser in Mandibular Third Molar Surgery
Official title: Low Power Laser in the Second Molar Tissue Repair and in the Postoperative of Mandibular Third Molar Surgery - Double Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Therapy, Low-Level
Keywords: Third molar;
Third molar surgery;
Laser;
Tissue Repair.
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample of this study will be composed of 60 patients between 16 and 40 years old, who need to undergo the extraction of third molars included and / or impacted. The patients will be those who voluntarily seek the Discipline of Buccomaxillofacial Surgery and Traumatology, at the State University of São Paulo "Júlio de Mesquita Filho" - Unesp, to perform the procedure.

This study will be a randomized, double-blind, prospective clinical trial with the following groups:

Group I (with 20 patients) - laser therapy used in the immediate postoperative period will be intraoral irradiation with 660 nm red diode laser, 30 mW power and 10 J / cm2 fluency.

Group II (with 20 patients) - laser therapy used in the immediate postoperative period will be intraoral irradiation with 660 nm red diode laser, 30 mW power and 30 J / cm2 fluency.

Group III (with 20 patients) - Control Group - Application of laser sham.
Primary purpose: TREATMENT

Brief summary: 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%.

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Periodontal probing
timeFrame: Initially carried out in one, three and six months
Secondary outcomes:
measure: Pain assessment
timeFrame: Evaluated immediately, two, four, six and eight hours after surgery. And with continuity for one, two, three and four days
measure: Edema assessment
timeFrame: Initially carried out in three and seven days.
measure: Trismus assessment
timeFrame: Initially carried out in three and seven days
measure: Radiographic assessment
timeFrame: Assessment in one, three and six months
Other outcomes:
measure: Tissue repair
timeFrame: Assessment in three days
measure: Problems encountered after surgery
timeFrame: Assessment in four days
Locations:
Study officials:
affiliation: ICT-Unesp
name: Michelle B Moraes, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.