- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881827
Saliva Analysis After Low-level Laser Therapy Application on the Masseter Muscle Located Above Parotid Salivary Gland
Biochemistry and Volumetric Analysis of Biofluid Salivary, Correlating the Flow, pH and Buffer Capacity With and Without Stimulation of the Masseter Muscle, Before and After Low-level Laser Irradiation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Climate: The study will be conduced by Lasertherapy and Photobiology Center (CELAFO) at the Institute of Research and Development at the University of Vale do Paraíba (UNIVAP), which was air-conditioned with temperature at 22 ° C.
Volunteers: 30 male volunteers aged between 18 and 30 years.
Flow Analysis Salivary pH and saliva buffer capacity before LLLT and after LLLT: Two consecutive samples of whole saliva were obtained from each second volunteer. The first, unstimulated total saliva (UTS) and the second of stimulated total saliva (STS). Obtaining mechanically given by chewing a paraffin 5cm² fragment. The gathering was held in the afternoon and with the patient in breakfast for at least one hour. All the volunteers were instructed not to brush teeth or use mouthwash for one hour prior to saliva collection of the experiment. The samples were collected UTS and STS requesting voluntary saliva deposited directly into a sterile universal collector. Salivary samples were compared by the universal table salivary flow described by Saliva samples were centrifuged at 1200 rpm for 10 minutes. All saliva volume produced during the 5-minute period was measured using test tubes recorded in milliliters. The pH was measured by a pH meter device. To test the buffer capacity, the saliva (3 mL) was placed in a Falcon tube containing 9 mL of 0,005 normal hydrochloric acid, subjected to manual shaking for 10 seconds, then maintained at rest for 10 minutes with open Falcon tube, aiming evaporation gases such as carbon dioxide which could interfere with the analysis. After 10 minutes the pH was measured with litmus tape aid compared with the color scale provided by the manufacturer.
Low Level Laser Therapy (LLLT): The investigators used the LLLT after the first collection of saliva, control therapies were applied, placebo LLLT red and LLLT in the infrared.The treatment was applied with an interval of 7 days in a randomized, controlled, double-blind, by drawing lots. Irradiation of LLLT was conducted in eight (8) points on the skin in the masseter region. The distance between points was 1cm. To know exactly the location of points, transparency sheets were used (irradiation feedback) and reference points of each volunteer, as follows: point 1 commissure eyelid, point 2 in the tragus of the ear and point 3 on the labial commissure.The anticipated period of 15 minutes to occur the desired effects of LLLT was performed new material collection.
Data Analysis: The salivary flow data, pH and buffering capacity of saliva was analyzed using a analysis program statistics with the nonparametric Kruskal-Wallis test. The significance level was 5% (p <0.05)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São José dos Campos, SP, Brazil, 55
- Leandro Júnio Masulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria :
- Have all dental organs
- Male volunteers
- Age between 18 and 30 years
- Body mass index between 18.5 and 25 (normal) .
Exclusion Criteria:
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
- Bruxism
- Use of partial or full dentures .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Infrared Laser
Using a laser in the infrared wave spectrum (780 nm)
|
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.
|
Active Comparator: Red Laser
Using laser red wave spectrum (662 nm)
|
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.
|
Placebo Comparator: Placebo
Simulation of treatment with the device switched off
|
Simulation of treatment with the device switched off
|
Active Comparator: Control
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased salivary flow
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of the salivary pH
Time Frame: 24 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase in saliva buffer capacity
Time Frame: 24 months
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNIVAP - Masulo 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Saliva Altered
-
Mars WrigleyCompleted
-
University of KarachiAltamash Institute of Dental MedicineCompletedSaliva Altered | Electrolyte DisturbancePakistan
-
Dr Meru SCompletedOral Hygiene | pH | Saliva Altered | Tooth Structure; DisorderIndia
-
Dr Meru SCompletedOral Hygiene | pH | Saliva Altered | Tooth Structure; DisorderIndia
-
Dr Meru SCompletedOral Hygiene | pH | Saliva Altered | Tooth Structure; DisorderIndia
-
Cairo UniversityUnknownPlaque | Saliva AlteredEgypt
-
Rutgers, The State University of New JerseyCompleted
-
Rutgers UniversityActive, not recruitingTaste, Altered | Saliva AlteredUnited States
-
Purdue UniversityCompletedDiet Modification | Diet Habit | Taste, Altered | Saliva AlteredUnited States
-
Muğla Sıtkı Koçman UniversityCompletedPeriodontal Diseases | Dental Caries | Pregnancy Related | Saliva AlteredTurkey
Clinical Trials on Low level laser therapy
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
University of Nove de JulhoSimone Aparecida Penimpedo Calamita; Fabiana Sarilho de Mendonça; Daniela Aparecida... and other collaboratorsCompleted
-
St. Elisabethen Krankenhaus Frankfurt GmbHRecruitingSurgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyGermany
-
University of BergenCompleted
-
University of BergenNorwegian Fund for Postgraduate Training in PhysiotherapyCompleted
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São Paulo; Faculty of Medicine of... and other collaboratorsCompleted
-
University of OttawaBioFlexTM Laser TherapyCompletedProvoked VestibulodyniaCanada
-
NYU Langone HealthCompleted
-
Universidade do Vale do SapucaiCompletedBreast Neoplasms | Radiotherapy; Adverse Effect, Dermatitis or EczemaBrazil
-
University of Nove de JulhoConselho Nacional de Desenvolvimento Científico e TecnológicoNot yet recruitingPain, Postoperative | Endodontically Treated Teeth