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Low Power Laser in Mandibular Third Molar Surgery

U

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Completed

Conditions

Laser Therapy, Low-Level

Treatments

Radiation: Grupo III- Laser sham
Radiation: Grupo I- Lower laser fluency
Radiation: Grupo II- Greater laser fluency

Study type

Interventional

Funder types

Other

Identifiers

NCT03164252
47325515.3.0000.0077

Details and patient eligibility

About

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%.

Full 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%.

Enrollment

7 patients

Sex

All

Ages

16 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

7 participants in 3 patient groups, including a placebo group

Grupo I- Lower laser fluency
Active Comparator group
Description:
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
Treatment:
Radiation: Grupo II- Greater laser fluency
Radiation: Grupo III- Laser sham
Grupo II- Greater laser fluency
Active Comparator group
Description:
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
Treatment:
Radiation: Grupo I- Lower laser fluency
Radiation: Grupo III- Laser sham
Grupo III- Laser sham
Placebo Comparator group
Description:
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.
Treatment:
Radiation: Grupo II- Greater laser fluency
Radiation: Grupo I- Lower laser fluency

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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