Saliva Analysis After Low-level Laser Therapy Application on the Masseter Muscle Located Above Parotid Salivary Gland

NCT02881827 | Unknown DMC

• 1 other identifier: UNIVAP - Masulo 001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain experimental data on the possible changes that saliva may suffer when brought to low-level laser therapy protocols for analgesia in the masseter muscle, because this be on the Parotid salivary gland.

Conditions

Saliva Altered

Keywords

Saliva; Low-level laser therapy; Masseter muscle; Salivary glands

Outcome Measures

Primary Outcomes (1)

• Increased salivary flow

  Expect positive results of this research on the increased salivary flow , improved saliva buffer capacity as well as increased salivary pH enabling a better quality of life for patients.

  24 months

Secondary Outcomes (1)

• Improvement of the salivary pH

  24 months

Other Outcomes (1)

• Increase in saliva buffer capacity

  24 months

Study Arms (4)

Infrared Laser

ACTIVE COMPARATOR

Using a laser in the infrared wave spectrum (780 nm)

Radiation: Low level laser therapy

Red Laser

ACTIVE COMPARATOR

Using laser red wave spectrum (662 nm)

Radiation: Low level laser therapy

Placebo

PLACEBO COMPARATOR

Simulation of treatment with the device switched off

Other: Placebo

Control

ACTIVE COMPARATOR

A scientific control group allows the experimental study of a variable at a time, and is a vital part of the scientific method. In a controlled experiment, two identical experiments are conducted. In one, the treatment - tested factor - is applied. In another - control - the tested factor is not applied For example, when testing a drug, it is important to carefully check the suspected drug effects are produced by the drug. Doctors can it with a double-blind study in a clinical trial: two ( statistically ) identical groups of patients are compared, one gets the drug and the other receives a placebo. Neither subjects nor investigators know which group receives the actual drug , which serves to prevent bias and isolating effects of such drugs.

Other: Control

Interventions

Low level laser therapy RADIATION

Supported by the physical phenomenon of stimulated emission postulated by Albert Einstein in 1916 the laser (light amplification by Stimulated Emission of Radiation) is a device consisting of solid source materials, liquid or gas that produces beams of light when excited by a source of energy. This bright feature is a particular type of electromagnetic radiation, which differs from that emitted by conventional incandescent sources. These are the effects attributable to LLLT analgesic, anti-inflammatory and biostimulates and has been widely used due to low power densities and wavelengths with a penetration capacity in tissues without the generation of photothermal effects, which makes its feasible use multiple applications in Health area.

Infrared Laser; Red Laser

Placebo OTHER

Simulation of treatment with the device switched off

Placebo

Control OTHER

A scientific control group allows the experimental study of a variable at a time, and is a vital part of the scientific method. In a controlled experiment, two identical experiments are conducted. In one, the treatment - tested factor - is applied. In another - control - the tested factor is not applied. For example, when testing a drug, it is important to carefully check the suspected drug effects are produced by the drug. Doctors can it with a double-blind study in a clinical trial: two (statistically) identical groups of patients are compared, one gets the drug and the other receives a placebo. Neither subjects nor investigators know which group receives the actual drug, which serves to prevent bias and isolating effects of such drugs.

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have all dental organs
• Male volunteers
• Age between 18 and 30 years
• Body mass index between 18.5 and 25 (normal) .

You may not qualify if:

• Presence of problems that compromise the physiological activity of the masticatory system
• Neurological disorders
• Cerebral Palsy
• parafunctions :
• Sucking fingers
• Nail biting
• Nibble objects
• Bruxism
• Mouth breathing .
• Use of medication :
• Antihistamines
• Benzodiazepines
• Depressants of the central nervous system.
• Temporomandibular dysfunction:
• Clenching of the teeth

Sponsors & Collaborators

• Universidade do Vale do Paraíba: lead

Study Sites (1)

Leandro Júnio Masulo

São José dos Campos, São Paulo, 55, Brazil

Location

Related Links

• Lattes Curriculum

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 29, 2016
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2018
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)