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Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients

NCT03647813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-08-29

No results posted yet for this study

Summary

End-stage renal disease patients undergoing hemodialysis can present alteration in flow, concentrations and composition of saliva affecting oral health. This randomized placebo-controlled trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) in salivary parameters in chronic renal failure (CRF) patients undergoing hemodialysis. Forty-four patients with CRF on hemodialysis self-responded two questionnaires for oral health and salivary gland function perception. Thereafter, patients were clinically evaluated for the diagnosis of hypofunction of salivary glands and were randomly allocated into two groups: PBM group (n = 21), which received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point; and a placebo group (n = 17) that consisted of laser protocol with the device switched off. Patients were first submitted to sialometry and after to PBM or placebo intervention at baseline, 7 and 14 days. Non-stimulated and stimulated saliva were collected for salivary volume investigation and biochemical analysis of total protein, calcium and urea concentrations.

Conditions

  • Xerostomia
  • Chronic Renal Failure

Interventions

RADIATION

Photobiomodulation

Patients received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point.

RADIATION

Placebo

The same laser protocol was followed but with the device switched off.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-09-15
Completion
2017-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03647813 on ClinicalTrials.gov