Salivary Markers in Patients With Xerostomia

November 15, 2017 updated by: Pia Lopez Jornet, Universidad de Murcia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30008
        • Pia Lopez Jornet
      • Murcia, Spain, 30004
        • Pia Lopez Jornet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Exam
Time Frame: 4 months
Caries number, natural teeth number
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Murcia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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