N/A N=66 Randomized Single-blind Treatment

Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

KERATOCONJUNCTIVITIS SICCA · XEROSTOMIA · SICCA SYNDROME · PRIMARY SJOGREN SYNDROME

Bottom Line

View on ClinicalTrials.gov: NCT02066896 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: The Xerostomia Inventory — 40.2; 39.3 units on a scale — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lasertherapy (Device); Sham Lasertherapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federal University of São Paulo
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Xerostomia Inventory	40.2; 39.3	0.05
SECONDARY Salivary Biomarker Analysis. Beta 2 Microglobulin.	1.10; 0.84	—
SECONDARY Salivary Flux Measurement	0.100; 0.100	—

Summary

This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

Eligibility Criteria

Inclusion Criteria

Patients with primary Sjogren Syndrome according criteria american european 2002.
Salivary flux non stimulated < 0, 1 ml/min.

Exclusion Criteria

hepatitis B and/or C
radiotherapy in the glandular area (previous)
other connective diseases
thyroidopathy non compensated
GVHD graft-versus-host disease
HIV
Sarcoidosis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02066896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.