Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients

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.

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Key information

Conditions

Xerostomia Chronic Disease Chronic Renal Failure Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Salivary Gland Diseases Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photobiomodulation

Radiation

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

Placebo

Radiation

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

Primary outcomes

Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)

Time frame: Baseline, 7 days and 14 days.

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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Effects of Photobiomodulation Therapy in Salivary Analysis of Chronic Renal Failure Patients Undergoing Hemodialysis: a Randomized Placebo-controlled Trial

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 27, 2018
Registry last updated: Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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