Skip to main content
OpenTrials
Completed

NCT Number: NCT03156569

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Xerostomia Due to Hyposecretion of Salivary Gland

Sex eligibility

All sexes

Study type

Observational

Primary location

Pia Lopez Jornet, Murcia, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analysis of the saliva

Diagnostic Test

IFN-, IL-10, IL-1b, IL-4 and IL-6

Primary outcomes

  1. saliva flow rate

    Time frame: 2 months

    Unstimulated salivary flow rate. Pathological < or 1.5 ml/ 15 minutes.

  2. Xerostomia

    Time frame: 2 months

    Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).

  3. 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)

Secondary outcomes

  1. Oral Exam

    Time frame: 4 months

    Caries number, natural teeth number

  2. Periodontal evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Oral Health and Salivary Markers in Patients With Xerostomia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.