The purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto (HCFMRP-USP), and its impact on quality of life.
There will be two groups: Group 1 (G1) - will use a spray with pilocarpine for three months and after a washout period of a month, use a spray without pilocarpine for another three months; Group 2 (G2) - will use a spray without pilocarpine for three months and after a washout period of a month, use a spray with pilocarpine for another three months (in a randomized, controlled, duble blind and crossover study). Participants will be submitted to OHIP-14, Xerostomia Inventory (XI) and salivary flow measurement before the start of therapy - baseline (T0), one (T2), two (T3) and three (T4) months after starting the use of spray, after washout, crossover occurs and the same parameters are measured for the same periods (T0', T2', T3' and T4'), and is measured one hour after the saliva (T1 and T1') baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.
University of São Paulo
Ribeirão Preto, São Paulo, Brazil
RECRUITINGSalivary flow
measured by stimulated salivation
Time frame: baseline, 1 hour after baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
Quality of life
measured by Oral Health Impact Profile (OHIP-14)
Time frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
Xerostomia grade
measured by Xerostomia Inventory
Time frame: baseline and each 30 days up to 90 days until start the wash out, and after crossover will repeat these time frame measures
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