Salivary Markers in Patients With Xerostomia
Oral Health and Salivary Markers in Patients With Xerostomia
1 other identifier
observational
30
1 country
2
Brief Summary
The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedNovember 17, 2017
November 1, 2017
1.2 years
May 1, 2017
November 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
saliva flow rate
Unstimulated salivary flow rate. Pathological \< or 1.5 ml/ 15 minutes.
2 months
Xerostomia
Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).
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)
2 months
Secondary Outcomes (2)
Oral Exam
4 months
Periodontal evaluation
4 months
Interventions
IFN-, IL-10, IL-1b, IL-4 and IL-6
Eligibility Criteria
Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University
You may qualify if:
- The patient must have clinical symptoms of xerostomia (dry mouth)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pia Lopez Jornet
Murcia, 30004, Spain
Pia Lopez Jornet
Murcia, 30008, Spain
Related Publications (4)
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.
PMID: 24750447BACKGROUNDvan 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.
PMID: 17451498RESULTLiukkonen 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.
PMID: 27541079RESULTTvarijonaviciute 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.
PMID: 30030617DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD DDS PhD
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 17, 2017
Study Start
January 1, 2016
Primary Completion
March 1, 2017
Study Completion
October 1, 2017
Last Updated
November 17, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share