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Saliva Profiles in Children With Congenital Heart Disease

Primary Purpose

Cardiac Disease, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
saliva
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Disease focused on measuring saliva composition, antioxidant activity, caries risk factors, congenital cardiac disease

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 3-12 years
  • Caridac problems

Exclusion Criteria:

  • other ages
  • syndromes
  • other systemic diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    congenital heart disease

    helathy children

    Arm Description

    42 patients

    42 children

    Outcomes

    Primary Outcome Measures

    salivary secretion rate
    salivary secretion rate
    salivary buffering capacity
    salivary buffering capacity
    pH
    pH

    Secondary Outcome Measures

    protein levels of saliva
    protein levels
    superoxide dismutase (SOD)
    superoxide dismutase (SOD)
    ferric reducing antioxidant power (FRAP)
    ferric reducing antioxidant power (FRAP)
    the thiobarbituric acid reactive substances (TBARS)
    the thiobarbituric acid reactive substances (TBARS)

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    March 1, 2018
    Sponsor
    Istanbul University
    Collaborators
    Figen Seymen, Merve Bayram, Ezel Uslu, Sule Batu, Yegane Güven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03457974
    Brief Title
    Saliva Profiles in Children With Congenital Heart Disease
    Official Title
    Saliva Profiles in Children With Congenital Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2011 (Actual)
    Primary Completion Date
    January 1, 2012 (Actual)
    Study Completion Date
    January 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University
    Collaborators
    Figen Seymen, Merve Bayram, Ezel Uslu, Sule Batu, Yegane Güven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.
    Detailed Description
    Using heart failure medications may cause low salivary pH and buffering capacity.As improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up. This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Disease, Dental Caries
    Keywords
    saliva composition, antioxidant activity, caries risk factors, congenital cardiac disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    cross sectional study was carried out with 42 CHD and 42 healthy children
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    congenital heart disease
    Arm Type
    Experimental
    Arm Description
    42 patients
    Arm Title
    helathy children
    Arm Type
    Other
    Arm Description
    42 children
    Intervention Type
    Other
    Intervention Name(s)
    saliva
    Intervention Description
    salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
    Primary Outcome Measure Information:
    Title
    salivary secretion rate
    Description
    salivary secretion rate
    Time Frame
    2 hour
    Title
    salivary buffering capacity
    Description
    salivary buffering capacity
    Time Frame
    2 hour
    Title
    pH
    Description
    pH
    Time Frame
    2 hour
    Secondary Outcome Measure Information:
    Title
    protein levels of saliva
    Description
    protein levels
    Time Frame
    2 hour
    Title
    superoxide dismutase (SOD)
    Description
    superoxide dismutase (SOD)
    Time Frame
    2 hour
    Title
    ferric reducing antioxidant power (FRAP)
    Description
    ferric reducing antioxidant power (FRAP)
    Time Frame
    2 hour
    Title
    the thiobarbituric acid reactive substances (TBARS)
    Description
    the thiobarbituric acid reactive substances (TBARS)
    Time Frame
    2 hour
    Other Pre-specified Outcome Measures:
    Title
    protein carbonyl
    Description
    protein carbonyl
    Time Frame
    2 hour
    Title
    protein thiols
    Description
    protein thiols
    Time Frame
    2 hour
    Title
    total sialic acid
    Description
    total sialic acid
    Time Frame
    2 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 3-12 years Caridac problems Exclusion Criteria: other ages syndromes other systemic diseases

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Saliva Profiles in Children With Congenital Heart Disease

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