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

NCT03355313 | Unknown

• 1 other identifier: Malnutrition
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Malnutrition, Child

Keywords

saliva; Low-level light therapy; salivary glands

Outcome Measures

Primary Outcomes (1)

• Low-level laser irradiation on the salivary glands

  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 Outcomes (5)

• Length/Height

  1 week

• Weight

  1 week

• Saliva flow rate measurement

  3 weeks

• Buffering Capacity of saliva

  3 weeks

• Analysis of salivary IgA

  3 weeks

Study Arms (3)

Low level light therapy 1

EXPERIMENTAL

Radiation: Low level Light therapy

Low level light therapy 2

EXPERIMENTAL

Radiation: Low level Light therapy

Low level light therapy 3

EXPERIMENTAL

Radiation: Low level Light therapy

Interventions

Low level Light therapy RADIATION

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.

Low level light therapy 1; Low level light therapy 2; Low level light therapy 3

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Centro de Educação e Recuperação Nutricional

Maceió, Alagoas, 57000000, Brazil

Location

University of Nove de Julho

São Paulo, 01504000, Brazil

Location

Related Publications (11)

• Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.

  PMID: 18207566 BACKGROUND

• Johansson I, Saellstrom AK, Rajan BP, Parameswaran A. Salivary flow and dental caries in Indian children suffering from chronic malnutrition. Caries Res. 1992;26(1):38-43. doi: 10.1159/000261425.

  PMID: 1568235 BACKGROUND

• Vidovic Juras D, Lukac J, Cekic-Arambasin A, Vidovic A, Canjuga I, Sikora M, Carek A, Ledinsky M. Effects of low-level laser treatment on mouth dryness. Coll Antropol. 2010 Sep;34(3):1039-43.

  PMID: 20977100 BACKGROUND

• Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6.

  PMID: 21054200 BACKGROUND

• Michalke B, Rossbach B, Goen T, Schaferhenrich A, Scherer G. Saliva as a matrix for human biomonitoring in occupational and environmental medicine. Int Arch Occup Environ Health. 2015 Jan;88(1):1-44. doi: 10.1007/s00420-014-0938-5. Epub 2014 Mar 12.

  PMID: 24619390 BACKGROUND

• Navazesh M, Christensen CM. A comparison of whole mouth resting and stimulated salivary measurement procedures. J Dent Res. 1982 Oct;61(10):1158-62. doi: 10.1177/00220345820610100901. No abstract available.

  PMID: 6956596 BACKGROUND

• Psoter WJ, Spielman AL, Gebrian B, St Jean R, Katz RV. Effect of childhood malnutrition on salivary flow and pH. Arch Oral Biol. 2008 Mar;53(3):231-7. doi: 10.1016/j.archoralbio.2007.09.007. Epub 2007 Nov 5.

  PMID: 17983611 BACKGROUND

• Reddy V, Raghuramulu N, Bhaskaram C. Secretory IgA in protein-calorie malnutrition. Arch Dis Child. 1976 Nov;51(11):871-4. doi: 10.1136/adc.51.11.871.

  PMID: 827242 BACKGROUND

• Rodriguez PN, Martinez Reinoso J, Gamba CA, Salgado PA, Mateo MT, Manto Mdel C, Molgatini SL, Iglesias V, Argentieri AB. Association among salivary flow rate, caries risk and nutritional status in pre-schoolers. Acta Odontol Latinoam. 2015;28(2):185-91. doi: 10.1590/S1852-48342015000200015.

  PMID: 26355891 BACKGROUND

• Simoes A, de Campos L, de Souza DN, de Matos JA, Freitas PM, Nicolau J. Laser phototherapy as topical prophylaxis against radiation-induced xerostomia. Photomed Laser Surg. 2010 Jun;28(3):357-63. doi: 10.1089/pho.2009.2486.

  PMID: 19814701 BACKGROUND

• Vieira KA, Bastos CM, Vitor MGC, Deana AM, Fernandes KPS, Rodrigues MFSD, Pavesi VCS, Bussadori SK. Use of low-level laser therapy on children aged 1 to 5 years with energy-protein malnutrition: A clinical trial. Medicine (Baltimore). 2018 Apr;97(17):e0538. doi: 10.1097/MD.0000000000010538.

  PMID: 29703031 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESOR

Model Details: Nutritional status of 50 children will be measured according the World Health Organization. The volume of saliva will be measured and, also, the salivary flow rate(mL/min) and buffering capacity will be determined. Concentrations of salivary IgA in all samples will be measured using a ELISA kit. 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. Three sessions of laser therapy will occur (after the collection of saliva, 7 and 14 days after the first session, respectively). The final saliva collection will be performed after the third laser session. The laser will be adjusted according to the following parameters: 808nm, 4 J, Continuous and contact mode,100mW, Irradiation at target (mW/cm2)=2500,Irradiated area (cm2)=0.40.

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 28, 2017
• Study Start: September 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: July 30, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BR (2)