Hipossalivation Xerostomia
Conditions
Interventions
120 patients will be divided into the following intervention groups:
Intervention 1 - tablet pilocarpine mucous patch 5 mg topical action that
it will be applied to the buccal mucosa (topical administ
Intervention 2 - tablet placebo sticky mucus
which will be applied to the buccal mucosa (topical administration) at a dosage of 8/8 hours
Intervention 3-5mg tablets of
pilocarpine systemic oral use at 8/8 hour dosage (oral administration).
As this is a cross-over trial, all participants receive the drug at different times
Drug
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers aged 18 or over. With clinical diagnosis of hyposalivation salivary flow at rest less than or equal to 0.1 ml / min for at least two weeks before the research with no probability of resolution during the experimental period. There is no known allergy or sensitivity to pilocarpine.Ability to give informed consent in writing and meet all testing requirements.
Exclusion criteria
Exclusion criteria: No possibility of changing any drug with the potential to cause xerostomia within the research period. No intervention such as: radiotherapy, chemotherapy, surgery that could change the symptoms of xerostomia in the two weeks prior to the survey or during the study period. Eye problems contraindicate the use of parasympathetic agents (eg iridocyclitis, increased intraocular pressure). Other conditions, where there is a risk of worsening of medical problems during the evaluation period (eg severe or uncontrolled asthma or pulmonary disease, hypo or hypertension (uncontrolled), hyperthyroidism, uncontrolled seizures or cardiac arrhythmias, HIV and Hepatitis C). Established oral infections (eg, candidiasis, herpes infections, mucositis, canker sores).Pregnant women and smokers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase salivary flow rate at rest to normal levels, 0.3 ml / min. Parameter measured through the technique of sialometry.;It was verified, through sialometry at rest, that there was a statistically significant increase of salivary flow greater or equal to 0.3 ml / min, in the two interventions proposed, in 65% of the patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimize the side effects attributed to Pilocarpine. Parameter measured through symptom diary.;It was verified through the symptoms diary that there were no adverse effects during the interventions. | — |
Countries
Brazil
Contacts
Public ContactGeorge Gusmão
Universidade Federal de Pernambuco
Outcome results
None listed