Trials / Completed
CompletedNCT03647813
Effects of Photobiomodulation in Salivary Analysis of Chronic Renal Failure Patients
Effects of Photobiomodulation Therapy in Salivary Analysis of Chronic Renal Failure Patients Undergoing Hemodialysis: a Randomized Placebo-controlled Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- University of Nove de Julho · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2017-09-15
- Completion
- 2017-09-30
- First posted
- 2018-08-27
- Last updated
- 2018-08-29
Source: ClinicalTrials.gov record NCT03647813. Inclusion in this directory is not an endorsement.