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Salivary Markers in Patients With Xerostomia

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ClinicalTrials.gov Identifier: NCT03156569
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Pia Lopez Jornet, 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

Condition or disease Intervention/treatment
Xerostomia Due to Hyposecretion of Salivary Gland Diagnostic Test: Analysis of the saliva

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Oral Health and Salivary Markers in Patients With Xerostomia
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients Oral Medicine Hospital Morales Meseguer Clinica Odontologica University
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156569


Locations
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Spain
Pia Lopez Jornet
Murcia, Spain, 30004
Pia Lopez Jornet
Murcia, Spain, 30008
Sponsors and Collaborators
Universidad de Murcia

Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pia Lopez Jornet, MD DDS PhD, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT03156569     History of Changes
Other Study ID Numbers: University of Murcia
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pia Lopez Jornet, Universidad de Murcia:
saliva , dental , oral health

Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases