Xerostomia Due to Hyposecretion of Salivary GlandNCT03156569
Salivary Markers in Patients With Xerostomia
An observational study of Xerostomia Due to Hyposecretion of Salivary Gland, run by Universidad de Murcia at 2 sites in Spain.
Trial summary
The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Xerostomia Due to Hyposecretion of Salivary Gland
- What is being tested?
- Analysis of the saliva
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2016to Oct 2017
- How long will I take part?
- 4 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University
Who may be able to join
- The patient must have clinical symptoms of xerostomia (dry mouth)
Who cannot join
- Head and neck radiotherapy
- Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months
- Patients who are unable or unwilling to cooperate
- Patient suffering from cancer
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Oral Health and Salivary Markers in Patients With Xerostomia
The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient
Read the detailed description
Primary Outcome Measures:
- salivary Proinflammatory and anti-inflammatory cytokines
- questionnaire is provided to the patient for xerostomia characterization
Secondary Outcome Measures:
- Probing pocket depth
- Probing pocket depth and clinical attachment level
- Gingival index
- Plaque index
- Bleeding on probing
- Being tested
- Analysis of the saliva
- Keywords
- saliva , dental , oral health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the salivaDiagnostic test
IFN-, IL-10, IL-1b, IL-4 and IL-6
What is being measured
The primary outcome is the main question the study is designed to answer.
saliva flow rate
Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes.
Measured: 2 months
Xerostomia
Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).
Measured: 2 months
Interleukins
Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml)
Measured: 2 months
Secondary outcomes (2)
Oral Exam
Caries number, natural teeth number
Measured: 4 months
Periodontal evaluation
periodontal( gingival index, bleeding index, clinical attachment level, probing depth,number dental implant .A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects according to American Academy of Periodontology classification of periodontal diagnosis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJan 2016
- Primary completionMar 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Xerostomia Due to Hyposecretion of Salivary GlandStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156569
- Sponsor's protocol ID
- University of Murcia
- Status last verified
- Nov 2017
- First submitted
- 1 May 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohyama K, Moriyama M, Hayashida JN, Tanaka A, Maehara T, Ieda S, Furukawa S, Ohta M, Imabayashi Y, Nakamura S. Saliva as a potential tool for diagnosis of dry mouth including Sjogren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15.
PubMed 24750447van den Berg I, Pijpe J, Vissink A. Salivary gland parameters and clinical data related to the underlying disorder in patients with persisting xerostomia. Eur J Oral Sci. 2007 Apr;115(2):97-102. doi: 10.1111/j.1600-0722.2007.00432.x.
PubMed 17451498Liukkonen J, Gursoy UK, Pussinen PJ, Suominen AL, Kononen E. Salivary Concentrations of Interleukin (IL)-1beta, IL-17A, and IL-23 Vary in Relation to Periodontal Status. J Periodontol. 2016 Dec;87(12):1484-1491. doi: 10.1902/jop.2016.160146. Epub 2016 Aug 19.
PubMed 27541079Tvarijonaviciute A, Zamora C, Martinez-Subiela S, Tecles F, Pina F, Lopez-Jornet P. Salivary adiponectin, but not adenosine deaminase, correlates with clinical signs in women with Sjogren's syndrome: a pilot study. Clin Oral Investig. 2019 Mar;23(3):1407-1414. doi: 10.1007/s00784-018-2570-3. Epub 2018 Jul 20.
PubMed 30030617
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Salivary Markers in Patients With Xerostomia
- ClinicalTrials.gov ID
- NCT03156569
- Acronym / sponsor ID
- University of Murcia
- Keywords
- saliva , dental , oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 17 May 2017 (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 purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient
Detailed description
Primary Outcome Measures:
- salivary Proinflammatory and anti-inflammatory cytokines
- questionnaire is provided to the patient for xerostomia characterization
Secondary Outcome Measures:
- Probing pocket depth
- Probing pocket depth and clinical attachment level
- Gingival index
- Plaque index
- Bleeding on probing
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University
Key inclusion criteria (1 listed)
- The patient must have clinical symptoms of xerostomia (dry mouth)
Key exclusion criteria (4 listed)
- Head and neck radiotherapy
- Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months
- Patients who are unable or unwilling to cooperate
- Patient suffering from cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of the salivaIFN-, IL-10, IL-1b, IL-4 and IL-6 | Diagnostic test | – |
Primary outcome
saliva flow rate
Time frame: 2 months
Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes.
Xerostomia
Time frame: 2 months
Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).
Interleukins
Time frame: 2 months
Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml)
2 secondary outcomes
Oral Exam
Time frame: 4 months
Periodontal evaluation
Time frame: 4 months
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 17 Nov 2017.
- Background: PubMed 24750447Ohyama K, Moriyama M, Hayashida JN, Tanaka A, Maehara T, Ieda S, Furukawa S, Ohta M, Imabayashi Y, Nakamura S. Saliva as a potential tool for diagnosis of dry mouth including Sjogren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15.
- Results publication: PubMed 17451498van den Berg I, Pijpe J, Vissink A. Salivary gland parameters and clinical data related to the underlying disorder in patients with persisting xerostomia. Eur J Oral Sci. 2007 Apr;115(2):97-102. doi: 10.1111/j.1600-0722.2007.00432.x.
- Results publication: PubMed 27541079Liukkonen J, Gursoy UK, Pussinen PJ, Suominen AL, Kononen E. Salivary Concentrations of Interleukin (IL)-1beta, IL-17A, and IL-23 Vary in Relation to Periodontal Status. J Periodontol. 2016 Dec;87(12):1484-1491. doi: 10.1902/jop.2016.160146. Epub 2016 Aug 19.
- Derived from this study: PubMed 30030617Tvarijonaviciute A, Zamora C, Martinez-Subiela S, Tecles F, Pina F, Lopez-Jornet P. Salivary adiponectin, but not adenosine deaminase, correlates with clinical signs in women with Sjogren's syndrome: a pilot study. Clin Oral Investig. 2019 Mar;23(3):1407-1414. doi: 10.1007/s00784-018-2570-3. Epub 2018 Jul 20.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia Due to Hyposecretion of Salivary Gland, run by Universidad de Murcia at 2 sites in Spain.
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 4 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
What does the primary outcome measure?
saliva flow rate (time frame: 2 months). The study lists 3 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 NCT03156569, which also lists 4 linked publications.
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 17 Nov 2017.