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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%.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grupo I- Lower laser fluency | Active Comparator | 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 |
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| Grupo II- Greater laser fluency | Active Comparator | 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 |
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| Grupo III- Laser sham | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grupo I- Lower laser fluency | Radiation | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle B Moraes, PHD | ICT-Unesp | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17448851 | Result | 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. | |
| 21617973 | Result | 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. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
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Surgical procedures were always performed by the same surgeon and assistant, who were unaware of the surrogate group that belonged to the patient, as well as the patient himself. This randomization was performed involving numbers and envelopes, being only the investigator's knowledge.
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| Grupo II- Greater laser fluency | Radiation | 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. |
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| Grupo III- Laser sham | Radiation | 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. |
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| 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 |
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 |
| 21864969 | Result | 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. |
| D008722 | Methods |