This Present Study Can be Used by Clinicians Who Treat Psychiatric Patients: Dentists Might Expect Xerogenic Side Effects of Specific Psychiatric Drugs Which Can Affect Dental Treatment, and the Results Can Help Psychiatrist to Choose the Less Xerogenic Psychiatric Medication

May 19, 2025 updated by: Semmelweis University

Xerogenic Potential of the Most Frequently Prescribed Psychiatric Drugs

The goal of this observational study is to learn about the effects of psychiatric drug therapies on intra- and extra-oral sicca symptoms and salivation. The main question that it aims to answer is:

Does taking psychiatric medication cause oral dryness and/or any changes on whole and minor saliva secretion? Participants taking psychiatric medication answered a 16-question questionnare, and their saliva production was measured by Periotron device and by spitting method.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Outpatient Clinic, Department of Psychiatry and Psychotherapy and Dental Teaching Center, Semmelweis University, Budapest, Hungary

Description

Inclusion Criteria:

In the psychiatric group, the inclusion criteria was taking specific psychiatric medications.

Exclusion Criteria:

In the control group the exclusion criteria was reporting any diseases and taking medicines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unstimulated whole saliva flow rate (UWS)
Time Frame: through study completion, an average of 1 year
UWS was determined using the "spitting" method (Sreebny 2000). Whole saliva was collected for 5 minutes into a previously weighted empty cup, and then measured again after collecting the saliva. The results are in ml/min.
through study completion, an average of 1 year
Minor salivary gland (MSG) secretions
Time Frame: Through study completion, an average of 1 year
Palatal and labial MSG flow rates were measured by the Periotron 8010® (Oraflow Inc. Amytiville, USA) device with filter paper discs. The results are transferred into µl/cm2/min.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETT-TUKEB 55/2013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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