Low Power Laser in Mandibular Third Molar Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2016-12-06

Brief Summary

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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%.

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Detailed Description

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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%.

Conditions

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Laser Therapy, Low-Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Grupo II- Greater laser fluency

Intervention Type 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.

Grupo III- Laser sham

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Grupo I- Lower laser fluency

Intervention Type 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.

Grupo III- Laser sham

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Grupo I- Lower laser fluency

Intervention Type 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.

Grupo II- Greater laser fluency

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type RADIATION

Other Intervention Names

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Red laser diode of 660 nm/ power 30 mW/ creep of 10 J / cm2 Red laser diode of 660 nm/ power 30 mW/ creep of 30 J / cm2. Control group, application of laser sham

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Michelle Bianchi de Moraes

Professor Assistente Doutor - Departamento de Diagnóstico e Cirurgia - São Paulo State University (Unesp), Institute of Science and Technology, São José dos Campos, Brasil.

Responsibility Role PRINCIPAL_INVESTIGATOR