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Completed

NCT Number: NCT03457974

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.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Dental Caries Heart Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3-12 years
  • Caridac problems

Exclusion criteria

  • other ages
  • syndromes
  • other systemic diseases

Treatment and study plan

saliva

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Ezel Uslu
  • Figen Seymen
  • Merve Bayram
  • Sule Batu
  • Yegane Güven

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2018
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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