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Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients

Primary Purpose

Xerostomia, Chronic Renal Failure

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Placebo
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable cardiopulmonary and neurological conditions;
  • Hb> 10.9 g / dl and Hematocrit> 33;
  • Absence of acute systemic infectious processes;
  • Blood pressure <140 mmHg and PAd <90 mmHg in at least two measurements in two subsequent dialysis;
  • No hypervolemia;
  • Patients over 18 years-old;
  • Signed a statement of informed consent.

Exclusion Criteria:

  • Patients in intensive care unit;
  • Hemodynamic instability, signs and symptoms of uremic syndrome related to the cardiovascular and neurological systems;
  • Presence of acute systemic infectious processes;
  • Presence of acute cardiovascular disease, systolic blood pressure > 141 mmHg and / or diastolic blood pressure > 91 mmHg;
  • Significant anemia (Hb <11 g / dl and Hto <33%);
  • Photosensitivity;
  • Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Photobiomodulation group

    Placebo group

    Arm Description

    Patients were submitted to three sessions of PBM (baseline, 7 and 14 days). PBMT was administered by a single professional using a continuous wave AsGaAl diode laser (Photon Lase III - DMC, São Paulo, Brazil) with a wavelength of 808 nm (infrared). Irradiation was performed in punctual contact mode (ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point). A total of 20 points were applied in each session/day being three extraoral points in the parotid region (right and left n=6), three points in buccal mucosa (right and left, n=6), two extraoral (right and left, n=4) and two intraoral (right and left, n=4) points in the submandibular and sublingual regions.

    Patients were submitted to same protocol as the photobiomodulation group, but the laser was turned off.

    Outcomes

    Primary Outcome Measures

    Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
    Non-stimulated salivary collection was obtained with patient seated with heads slightly forward and a graduated collector tube positioned under the lower lip for 5 minutes to collect saliva. To obtain the stimulated saliva, patients stayed in the same position and chewed a piece of silicone of a standard size for 5 minutes. All the saliva produced was dispensed in another graduated tube. Salivary volumes were calculated using the difference in weight before and after collection provided a ratio with the volume in milliliters of expelled saliva. An analysis of salivary total proteins, urea and calcium levels were quantified in triplicates using colorimetric analysis with commercially available kits (Bioclin, Belo Horizonte, Minas Gerais,Brazil) and a spectrophotometer (Anthos 2020 - Asys - Austria) end point methods The absorbance for each marker was measured using the wavelength indicated by manufacture.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2018
    Last Updated
    August 27, 2018
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03647813
    Brief Title
    Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients
    Official Title
    Effects of Photobiomodulation Therapy in Salivary Analysis of Chronic Renal Failure Patients Undergoing Hemodialysis: a Randomized Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    September 15, 2017 (Actual)
    Study Completion Date
    September 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Xerostomia, Chronic Renal Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Masking Description
    Only one researcher knew in which group the patients were allocated and performed all the treatments. A blinded researcher performed all the evaluations after the procedures. The patient was also blinded to the treatment as the laser was turned off, simulating the treatment.
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Photobiomodulation group
    Arm Type
    Active Comparator
    Arm Description
    Patients were submitted to three sessions of PBM (baseline, 7 and 14 days). PBMT was administered by a single professional using a continuous wave AsGaAl diode laser (Photon Lase III - DMC, São Paulo, Brazil) with a wavelength of 808 nm (infrared). Irradiation was performed in punctual contact mode (ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point). A total of 20 points were applied in each session/day being three extraoral points in the parotid region (right and left n=6), three points in buccal mucosa (right and left, n=6), two extraoral (right and left, n=4) and two intraoral (right and left, n=4) points in the submandibular and sublingual regions.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients were submitted to same protocol as the photobiomodulation group, but the laser was turned off.
    Intervention Type
    Radiation
    Intervention Name(s)
    Photobiomodulation
    Intervention Description
    Patients received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point.
    Intervention Type
    Radiation
    Intervention Name(s)
    Placebo
    Intervention Description
    The same laser protocol was followed but with the device switched off.
    Primary Outcome Measure Information:
    Title
    Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)
    Description
    Non-stimulated salivary collection was obtained with patient seated with heads slightly forward and a graduated collector tube positioned under the lower lip for 5 minutes to collect saliva. To obtain the stimulated saliva, patients stayed in the same position and chewed a piece of silicone of a standard size for 5 minutes. All the saliva produced was dispensed in another graduated tube. Salivary volumes were calculated using the difference in weight before and after collection provided a ratio with the volume in milliliters of expelled saliva. An analysis of salivary total proteins, urea and calcium levels were quantified in triplicates using colorimetric analysis with commercially available kits (Bioclin, Belo Horizonte, Minas Gerais,Brazil) and a spectrophotometer (Anthos 2020 - Asys - Austria) end point methods The absorbance for each marker was measured using the wavelength indicated by manufacture.
    Time Frame
    Baseline, 7 days and 14 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stable cardiopulmonary and neurological conditions; Hb> 10.9 g / dl and Hematocrit> 33; Absence of acute systemic infectious processes; Blood pressure <140 mmHg and PAd <90 mmHg in at least two measurements in two subsequent dialysis; No hypervolemia; Patients over 18 years-old; Signed a statement of informed consent. Exclusion Criteria: Patients in intensive care unit; Hemodynamic instability, signs and symptoms of uremic syndrome related to the cardiovascular and neurological systems; Presence of acute systemic infectious processes; Presence of acute cardiovascular disease, systolic blood pressure > 141 mmHg and / or diastolic blood pressure > 91 mmHg; Significant anemia (Hb <11 g / dl and Hto <33%); Photosensitivity; Pregnancy.

    12. IPD Sharing Statement

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    Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients

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