Psychiatric DisordersNCT06920472
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
An observational study of Psychiatric Disorders and Xerostomia Due to Hyposecretion of Salivary Gland, run by Semmelweis University.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorders, Xerostomia Due to Hyposecretion of Salivary Gland
- How many people
- 361 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Outpatient Clinic, Department of Psychiatry and Psychotherapy and Dental Teaching Center, Semmelweis University, Budapest, Hungary
Who may be able to join
- In the psychiatric group, the inclusion criteria was taking specific psychiatric medications.
Who cannot join
- In the control group the exclusion criteria was reporting any diseases and taking medicines.
About this study
Official title: 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.
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstimulated whole saliva flow rate (UWS)
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.
Measured: through study completion, an average of 1 year
Minor salivary gland (MSG) secretions
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jan 2013
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920472
- Sponsor's protocol ID
- ETT-TUKEB 55/2013
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kovacs A, Karolyhazy K, Tolna J, Gotai L, Demeter T, Keremi B, Vag J, Marton K. Effects of frequently used psychiatric drugs on subjective dry mouth, salivary secretion and DMFT in outpatients. BMC Oral Health. 2026 Feb 28;26(1):594. doi: 10.1186/s12903-026-07958-8.
PubMed 41764456
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xerogenic Potential of the Most Frequently Prescribed Psychiatric Drugs
- ClinicalTrials.gov ID
- NCT06920472
- Acronym / sponsor ID
- ETT-TUKEB 55/2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatient Clinic, Department of Psychiatry and Psychotherapy and Dental Teaching Center, Semmelweis University, Budapest, Hungary
Key inclusion criteria (1 listed)
- In the psychiatric group, the inclusion criteria was taking specific psychiatric medications.
Key exclusion criteria (1 listed)
- In the control group the exclusion criteria was reporting any diseases and taking medicines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 41764456Kovacs A, Karolyhazy K, Tolna J, Gotai L, Demeter T, Keremi B, Vag J, Marton K. Effects of frequently used psychiatric drugs on subjective dry mouth, salivary secretion and DMFT in outpatients. BMC Oral Health. 2026 Feb 28;26(1):594. doi: 10.1186/s12903-026-07958-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorders and Xerostomia Due to Hyposecretion of Salivary Gland, run by Semmelweis University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unstimulated whole saliva flow rate (UWS) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.