Low Power Laser in Mandibular Third Molar Surgery

NCT03164252 | Completed DMC

• 1 other identifier: 47325515.3.0000.0077
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

Laser Therapy, Low-Level

Keywords

Third molar;; Third molar surgery;; Laser;; Tissue Repair.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain assessment

  Evaluated immediately, two, four, six and eight hours after surgery. And with continuity for one, two, three and four days

• Edema assessment

  Initially carried out in three and seven days.

• Trismus assessment

  Initially carried out in three and seven days

• Radiographic assessment

  Assessment in one, three and six months

Other Outcomes (2)

• Tissue repair

  Assessment in three days

• Problems encountered after surgery

  Assessment in four days

Study Arms (3)

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

Radiation: Grupo II- Greater laser fluency; Radiation: Grupo III- Laser sham

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

Radiation: Grupo I- Lower laser fluency; Radiation: Grupo III- Laser sham

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.

Radiation: Grupo I- Lower laser fluency; Radiation: Grupo II- Greater laser fluency

Interventions

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.

Also known as: Red laser diode of 660 nm/ power 30 mW/ creep of 10 J / cm2

Grupo II- Greater laser fluency; Grupo III- Laser sham

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.

Also known as: Red laser diode of 660 nm/ power 30 mW/ creep of 30 J / cm2.

Grupo I- Lower laser fluency; Grupo III- Laser sham

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.

Also known as: Control group, application of laser sham

Grupo I- Lower laser fluency; Grupo II- Greater laser fluency

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (3)

• 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.

  PMID: 17448851 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.

  PMID: 21617973 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.

  PMID: 21864969 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michelle B Moraes, PHD

  ICT-Unesp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Assistente Doutor - Departamento de Diagnóstico e Cirurgia - São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil.

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 23, 2017
• Study Start: February 23, 2016
• Primary Completion: June 7, 2016
• Study Completion: December 6, 2016
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share