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Saliva Profiles in Children With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT03457974
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Figen Seymen
Merve Bayram
Ezel Uslu
Sule Batu
Yegane Güven
Information provided by (Responsible Party):
Mine Koruyucu, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Dental Caries Other: saliva Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cross sectional study was carried out with 42 CHD and 42 healthy children
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Saliva Profiles in Children With Congenital Heart Disease
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : January 1, 2012
Actual Study Completion Date : January 1, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: congenital heart disease
42 patients
Other: saliva
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.

helathy children
42 children
Other: saliva
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 Measures :
  1. salivary secretion rate [ Time Frame: 2 hour ]
    salivary secretion rate

  2. salivary buffering capacity [ Time Frame: 2 hour ]
    salivary buffering capacity

  3. pH [ Time Frame: 2 hour ]
    pH


Secondary Outcome Measures :
  1. protein levels of saliva [ Time Frame: 2 hour ]
    protein levels

  2. superoxide dismutase (SOD) [ Time Frame: 2 hour ]
    superoxide dismutase (SOD)

  3. ferric reducing antioxidant power (FRAP) [ Time Frame: 2 hour ]
    ferric reducing antioxidant power (FRAP)

  4. the thiobarbituric acid reactive substances (TBARS) [ Time Frame: 2 hour ]
    the thiobarbituric acid reactive substances (TBARS)


Other Outcome Measures:
  1. protein carbonyl [ Time Frame: 2 hour ]
    protein carbonyl

  2. protein thiols [ Time Frame: 2 hour ]
    protein thiols

  3. total sialic acid [ Time Frame: 2 hour ]
    total sialic acid



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 3-12 years
  • Caridac problems

Exclusion Criteria:

  • other ages
  • syndromes
  • other systemic diseases

Responsible Party: Mine Koruyucu, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03457974     History of Changes
Other Study ID Numbers: 2010/1109-378
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Mine Koruyucu, Istanbul University:
saliva composition
antioxidant activity
caries risk factors
congenital cardiac disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Dental Caries
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs