Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition

November 21, 2017 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Malnutrition is a clinical-social disease caused by multiple prenatal, intrauterine and postnatal factors as well as social, political and cultural determinants (distal causes). Despite the global and national reductions in the number of cases, malnutrition continues to be a public health problem, with greater prevalence in pockets of poverty found in the northern and northeastern regions of Brazil.

Episodes of malnutrition in early childhood, with consequent calcium, phosphate and vitamin A, C and D deficiencies, can increase one's susceptibility to dental caries through three probable mechanisms: defects in tooth formation (odontogenesis), delayed tooth eruption and alterations in the salivary glands.

It is likely that the significant increase in susceptibility to caries in malnourished individuals stems from alterations in the salivary secretion rate, since a reduction in salivary flow (salivary gland atrophy) increases the susceptibility to both dental caries and dental erosion. As saliva is the main defense factor of the oral cavity, a reduction/change in its physical properties (secretion rate and buffering capacity) can cause immunological disorders that affect an individual's defense capacity.

Studies have demonstrated that salivary immunoglobulin A (IgA) also plays an important role in the immunity of the oral mucosa. Indeed, patients with IgA deficiency can experience recurring upper airway (tonsillitis, ear infection and sinusitis), lower airway (pneumonia) and gastrointestinal (diarrhea and parasitosis) infections.

The investigation of mechanisms that can reduce the impact of malnutrition on the defenses of the organism is of the utmost important and interest to public health. Among such mechanisms, low-level laser therapy has demonstrated effectiveness in the treatment of diverse conditions and disease through the promotion of the biomodulation of the cell metabolism and due to its analgesic and anti-inflammatory properties with no mutagenic or photothermal effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Laser stimulation of the major salivary glands to produce more saliva occurs through the increase in local circulation due to vasodilatation, the induction of the proliferation of glandular cells and cell respiration/ATP (adenosine triphosphate) synthesis as well as the release of growth factors and cytokines to stimulate protein exocytosis. With regard to an increase in salivary IgA, low-level laser intensifies the activation of B lymphocytes, which differentiate into plasma cells, thereby contributing to the increase in immunoglobulin levels.

The study of salivary aspects in malnourished children and possible treatments that can be used to improve salivary quality and quantity in these children has significant social relevance, as saliva is one of the main mechanisms against infection and participates in essential functions of life, such as swallowing and the maintenance of oral health.

An experimental cross-sectional study is proposed, which will be conducted at the Center for Educational and Nutrition Recovery in the city of Maceió, state of Alagoas, Brazil, and University Nove de Julho (UNINOVE) in the city of Sao Paulo, Brazil. This project has been approved by CESMAC ethics committee (CAAE 71961317.1.0000.0039).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 01504000
        • University of Nove de Julho
    • Alagoas
      • Maceió, Alagoas, Brazil, 57000000
        • Centro de Educação e Recuperação Nutricional

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged one to five years enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió whose parent/guardians signed as statement of informed consent agreeing to the participation of the children.
  • Children suffering of malnutrition.

Exclusion Criteria:

  • Children aged one to five years not enrolled at the Center for Educational and Nutrition Recovery in the city of Maceió and children whose parents/guardians did not sign a statement of informed consent.
  • Children not suffering of malnutrition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low level light therapy 1
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.
EXPERIMENTAL: Low level light therapy 2
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.
EXPERIMENTAL: Low level light therapy 3
Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low-level laser irradiation on the salivary glands
Time Frame: 3 weeks

Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.

The laser will be adjusted according to the following parameters:

Central wavelength (nm)= 808, Spectral band width (FWHM) (nm)= 2, Operational mode= Continuous, Mean radiant power (mW)=100, Polarization= Randomized, Aperture diameter (cm) =0.2, Irradiation at aperture (mW/cm2)= 2500, Beam profile= Multimodal, Beam spot on target (cm2)= 0.04, Irradiation at target (mW/cm2)= 2500, Exposure time (s)= 40, Radiant exposure (J/cm2)=100.0, Radiant energy (J)= 4, Number of points irradiated=10, Irradiated area (cm2) =0.40, Application method= Contact, Number of treatment sessions= 3, Frequency of treatment sessions per week =1, Total radiant energy (J) =40.

3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length/Height
Time Frame: 1 week

Length - A wooden measuring board (also called sliding board) will be used for measuring the length of children under two years old to the nearest millimetre.

Height - This is measured with the child in a standing position.

1 week
Weight
Time Frame: 1 week
A weighing sling (spring balance), also called the 'Salter Scale' will be used for measuring the weight of children under two years old, to the nearest 0.1 kg. Children over two years a beam balance will be used and the measurement is also to the nearest 0.1 kg.
1 week
Saliva flow rate measurement
Time Frame: 3 weeks

Salivary flow rates can be reduced significantly in individuals who have suffered severe malnutrition in early childhood.

Saliva parameters of children with malnutrition will be measured and compared to normal values.

Total resting saliva will be collected between 9 and 11 am (to avoid the influence of circadian rhythm) using the drainage method.

The child will be instructed to swallow prior to the collection and then instructed not to swallow, allowing the saliva to drain between the lips (which will be separated) into a test tube (aspirator) connected to a 15-mL Flacon tube positioned near the mouth.

Collection time will be five minutes. The volume of saliva will be measured and the salivary flow rate will be determined (mL/min).

Normal unstimulated salivary flux is above 0,2 ml/min. This measure was done in the samples of saliva before and after the lasertherapy for all patients.

3 weeks
Buffering Capacity of saliva
Time Frame: 3 weeks

One aliquot (1 ml) of saliva will be transferred immediately to a small tube (capacity: 5 ml) for titration with hydrochloric acid 0.005 Ne. The tube will be shaken for 15 seconds and buffering capacity will be measured using a glass electrode (Orion) coupled to a pH meter.

The reading of this test is performed based on the following parameters: pH 3.0 to 4.0 = very low to low buffering capacity; pH 4.5 to 5.0 = intermediate buffering capacity; and pH ≥ 5.5 = normal/good buffering capacity.

This measure was done in the samples of saliva before and after the lasertherapy for all patients.

3 weeks
Analysis of salivary IgA
Time Frame: 3 weeks

Concentrations of salivary IgA in all samples will be measured using a commercial enzyme-linked immunosorbent assay (ELISA) kit.

Salivary IgA (µg/ml) in each sample will be calculated using a standard curve obtained from the calibrators in the kit.

Normal saliva in children from 12 to 23 months = 2.3 ± 1.5 (mg/dl) Normal saliva in children from 24 to 71 months = 4.1 ± 2.4 (mg/dl) This measure was done in the samples of saliva before and after the lasertherapy for all patients.

3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ANTICIPATED)

July 30, 2018

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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