Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients

NCT ID: NCT03647813

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-09-30

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.

Conditions

Xerostomia; Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photobiomodulation group

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.

Group Type: ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type: RADIATION

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

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: RADIATION

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

Interventions

Photobiomodulation

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

Intervention Type: RADIATION

Placebo

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Vanessa

Identifier Type: -

Identifier Source: org_study_id