XerostomiaNCT00750828
Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth
An observational study of Xerostomia and Sjogren's Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The investigators questioned whether patients with dry mouth complaints display any reduction in residual saliva coating the gingiva and other selected mucosal surfaces. We further intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry mouth could be different from that of control… Read more about this study
- Who is it for?
- Ages 46 to 56 years, women only
- Conditions the study is for
- Xerostomia, Sjogren's Syndrome
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2004to Mar 2008
- 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 46 to 56 years
- Women only
- No healthy volunteers
- Adult
Study population: The data for this study were taken from 28 subjects at the Department of Periodontology, Hacettepe University from 2004 to 2007. The study group consisted of 14 patients with dry mouth complaints. All of them had the diagnosis of Sjögren's syndrome and ten of them were on therapy for sicca symptoms. Fourteen randomly selected age-matched systemically healthy females were also included as a control group
Who may be able to join
- For test group dry mouth complaints and with a diagnosis ofSjogren's Syndrome
Who cannot join
- Other medical problems that effect salivary glands
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Hacettepe University,
Ankara, 06100
About this study
The investigators questioned whether patients with dry mouth complaints display any reduction in residual saliva coating the gingiva and other selected mucosal surfaces. We further intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry mouth could be different from that of control subjects. Correlations between gingival/mucosal wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates and the correlations between clinical periodontal status and salivary measures were also attempted.
- Conditions
- Xerostomia, Sjogren's Syndrome
- Keywords
- Saliva, Sjögren's Syndrome, GCF, Oral Mucosal Wetness
- Medical subject headings
- Xerostomia, Sjogren's Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Investigators
- Burak Demiralp, DDS PhD, Study director, Hacettepe University Faculty of Dentistry Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750828
- Sponsor's protocol ID
- Hacettepe # FON 03/6-14
- Status last verified
- Sep 2008
- First submitted
- 10 Sep 2008
- Last updated
- 11 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth
- ClinicalTrials.gov ID
- NCT00750828
- Acronym / sponsor ID
- Hacettepe # FON 03/6-14
- Conditions
- Xerostomia, Sjogren's Syndrome
- Keywords
- Saliva, Sjögren's Syndrome, GCF, Oral Mucosal Wetness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Sep 2008 (estimated)
- 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 investigators questioned whether patients with dry mouth complaints display any reduction in residual saliva coating the gingiva and other selected mucosal surfaces. We further intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry mouth could be different from that of control subjects. Correlations between gingival/mucosal wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates and the correlations between clinical periodontal status and salivary measures were also attempted.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 46 to 56 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The data for this study were taken from 28 subjects at the Department of Periodontology, Hacettepe University from 2004 to 2007. The study group consisted of 14 patients with dry mouth complaints. All of them had the diagnosis of Sjögren's syndrome and ten of them were on therapy for sicca symptoms. Fourteen randomly selected age-matched systemically healthy females were also included as a control group
Key inclusion criteria (1 listed)
- For test group dry mouth complaints and with a diagnosis ofSjogren's Syndrome
Key exclusion criteria (1 listed)
- Other medical problems that effect salivary glands
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
Not reported in the source record.
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 11 Sep 2008.
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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.
Burak Demiralp, DDS PhD study director
Hacettepe University Faculty of Dentistry Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia and Sjogren's Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 11 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
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 11 Sep 2008.