Saliva Profiles in Children With Congenital Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Cardiac Disease
• Intervention / Treatment: Other: saliva

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
• Enrollment (Actual): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 3-12 years
• Caridac problems

Exclusion Criteria:

• other ages
• syndromes
• other systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary secretion rate	salivary secretion rate	2 hour
salivary buffering capacity	salivary buffering capacity	2 hour
pH	pH	2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
protein levels of saliva	protein levels	2 hour
superoxide dismutase (SOD)	superoxide dismutase (SOD)	2 hour
ferric reducing antioxidant power (FRAP)	ferric reducing antioxidant power (FRAP)	2 hour
the thiobarbituric acid reactive substances (TBARS)	the thiobarbituric acid reactive substances (TBARS)	2 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
protein carbonyl	protein carbonyl	2 hour
protein thiols	protein thiols	2 hour
total sialic acid	total sialic acid	2 hour

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Figen Seymen; Merve Bayram; Ezel Uslu; Sule Batu; Yegane Güven

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: antioxidant activity; saliva composition; caries risk factors; congenital cardiac disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Cardiovascular Abnormalities; Heart Diseases; Dental Caries; Heart Defects, Congenital
• Other Study ID Numbers: 2010/1109-378

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