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Effect of Pilocarpine mouthwash on diabetic patients xerostomia

Evaluation of the effect of 0/3% Pilocarpine mouthwash on xerostomia in diabetic patients with xerostomia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220930056061N1
Enrollment
80
Registered
2023-07-29
Start date
2023-07-26
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry mouth(xerostomia). Disturbances of salivary secretion

Interventions

Intervention 1: Intervention group: It is recommended for every person to keep 3 ml of 0/3% Pilocarpine mouthwash for 2 weeks in 3 meals a day (preferably after meals) in their mouth for 1 minute each

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having diabetes mellitus according to the diagnostic criteria of the American Diabetes Association Suffering from dry mouth according to the diagnosis based on the questionnaire of Fox et al desire and physical and mental ability to cooperate and use mouthwash correctly

Exclusion criteria

Exclusion criteria: History of uncontrolled asthma History of gastric ulcer Reluctance to cooperate with the study Acute or chronic use of medicine or mouthwash used to relieve dry mouth History of autoimmune disease Head and neck radiation therapy Infection with human immunodeficiency virus(HIV), hepatitis type B and hepatitis type C using of drugs effecting on the amount of saliva during the trial

Design outcomes

Primary

MeasureTime frame
Unstimulated saliva volume of the sample. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Saliva draining method, which is one of the simple and practical methods of measuring the volume of non-irritating saliva in studies, in this method, the person is asked to first wash his mouth with distilled or deionized water to empty it of small debris, then swallow the remaining saliva in their mouth and rest for five minutes, then sit in a quiet environment free of factors that stimulate or limit the secretion of saliva, bend their head down and spit the saliva collected in their mouth for 5 minutes from their lower lip into a 50 ml graduated test container (which has been accurately weighed and sterilized).;Intensity of xerostomia based on self-report of people. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Patients' self-reported questionnaire.;Intensity of xerostomia based on Fox questionnaire. Timepoint: before the start of the intervention, and 14 and 35 days after using mouthwash. Method of measurement: Fox et. al questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Shayan Shakeri

Kerman University of Medical Sciences

shayan.shakeri@yahoo.com+98 34 3213 4086

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026