Salivary Markers in Patients With Xerostomia

Xerostomia Due to Hyposecretion of Salivary Gland Clinical Trial

Official title:

Oral Health and Salivary Markers in Patients With Xerostomia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156569
• Other study ID #: University of Murcia
• Status: Completed
• Phase: N/A
• First received: May 1, 2017
• Last updated: November 15, 2017
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patient must have clinical symptoms of xerostomia (dry mouth)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Xerostomia
• Xerostomia Due to Hyposecretion of Salivary Gland

Intervention

Diagnostic Test:
• Analysis of the saliva
IFN-, IL-10, IL-1b, IL-4 and IL-6

Locations

Country	Name	City	State
Spain	Pia Lopez Jornet	Murcia
Spain	Pia Lopez Jornet	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Liukkonen J, Gürsoy UK, Pussinen PJ, Suominen AL, Könönen E. Salivary Concentrations of Interleukin (IL)-1ß, IL-17A, and IL-23 Vary in Relation to Periodontal Status. J Periodontol. 2016 Dec;87(12):1484-1491. Epub 2016 Aug 19. — View Citation

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 Sjögren's syndrome. Oral Dis. 2015 Mar;21(2):224-31. doi: 10.1111/odi.12252. Epub 2014 May 15. — View Citation

van 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	saliva flow rate	Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes.	2 months
Primary	Xerostomia	Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).	2 months
Primary	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	Oral Exam	Caries number, natural teeth number	4 months
Secondary	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	4 months