Salivary Markers in Patients With Xerostomia

Completed

• Conditions: Xerostomia Due to Hyposecretion of Salivary Gland

• Registration Number: NCT03156569
• Lead Sponsor: Universidad de Murcia

Brief Summary

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2017-03
• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interleukins	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)
saliva flow rate	2 months	Unstimulated salivary flow rate. Pathological \< or 1.5 ml/ 15 minutes.
Xerostomia	2 months	Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).

Secondary Outcome Measures

Name	Time	Method
Oral Exam	4 months	Caries number, natural teeth number
Periodontal evaluation	4 months	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

Trial Locations

Locations (1)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain