Saliva AlteredNCT02881827
Saliva Analysis After Low-level Laser Therapy Application on the Masseter Muscle Located Above Parotid Salivary Gland
A study testing Low level laser therapy in people with Saliva Altered, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Saliva Altered
- What is being tested?
- Low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have all dental organs
- Male volunteers
- Age between 18 and 30 years
- Body mass index between 18.5 and 25 (normal) .
Who cannot join
- Presence of problems that compromise the physiological activity of the masticatory system
- Neurological disorders
- Cerebral Palsy
- parafunctions :
- Sucking fingers
- Nail biting
Show all 17Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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)
- Conditions
- Saliva Altered
- Being tested
- Low level laser therapy, Placebo, Control
- Keywords
- Saliva, Low-level laser therapy, Masseter muscle, Salivary glands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyRadiation
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.
PlaceboOther
Simulation of treatment with the device switched off
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infrared Laser | Active comparator | Using a laser in the infrared wave spectrum (780 nm) Receives: Radiation: Low level laser therapy |
| Red Laser | Active comparator | Using laser red wave spectrum (662 nm) Receives: Radiation: Low level laser therapy |
| Placebo | Placebo comparator | Simulation of treatment with the device switched off Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Improvement of the salivary pH
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saliva AlteredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881827
- Sponsor's protocol ID
- UNIVAP - Masulo 001
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02881827
- Acronym / sponsor ID
- UNIVAP - Masulo 001
- Conditions
- Saliva Altered
- Keywords
- Saliva, Low-level laser therapy, Masseter muscle, Salivary glands
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infrared Laser | Active comparator | Radiation: Low level laser therapyUsing a laser in the infrared wave spectrum (780 nm) |
| Red Laser | Active comparator | Radiation: Low level laser therapyUsing laser red wave spectrum (662 nm) |
| Placebo | Placebo comparator | Other: PlaceboSimulation of treatment with the device switched off |
| Control | Active comparator | Other: ControlA 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have all dental organs
- Male volunteers
- Age between 18 and 30 years
- Body mass index between 18.5 and 25 (normal) .
Key exclusion criteria (17 listed)
- Presence of problems that compromise the physiological activity of the masticatory system
- Neurological disorders
- Cerebral Palsy
- Sucking fingers
- Nail biting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level laser therapySupported 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. | Radiation | Infrared Laser, Red Laser |
| PlaceboSimulation of treatment with the device switched off | Other | Placebo |
| ControlA 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 |
Primary outcome
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.
1 secondary outcome
Improvement of the salivary pH
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Lattes CurriculumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Saliva Altered
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Recruiting
Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
Saliva Altered
Recruiting
The Effects of Using Augmented Reality (AR) System to Train Foreign Care Workers.
Oral Dryness and Saliva Altered, Oral Manifestations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy in people with Saliva Altered, run by Universidade do Vale do Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased salivary flow (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.