NCT03457974

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

February 23, 2018

Last Update Submit

March 1, 2018

Conditions

Cardiac DiseaseDental Caries

Keywords

saliva compositionantioxidant activitycaries risk factorscongenital cardiac disease

Outcome Measures

Primary Outcomes (3)

  • salivary secretion rate

    salivary secretion rate

    2 hour

  • salivary buffering capacity

    salivary buffering capacity

    2 hour

  • pH

    pH

    2 hour

Secondary Outcomes (4)

  • protein levels of saliva

    2 hour

  • superoxide dismutase (SOD)

    2 hour

  • ferric reducing antioxidant power (FRAP)

    2 hour

  • the thiobarbituric acid reactive substances (TBARS)

    2 hour

Other Outcomes (3)

  • protein carbonyl

    2 hour

  • protein thiols

    2 hour

  • total sialic acid

    2 hour

Study Arms (2)

congenital heart disease

EXPERIMENTAL

42 patients

Other: saliva

helathy children

OTHER

42 children

Other: saliva

Interventions

salivaOTHER

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.

congenital heart diseasehelathy children

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years
  • Caridac problems

You may not qualify if:

  • other ages
  • syndromes
  • other systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart DiseasesDental Caries

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: cross sectional study was carried out with 42 CHD and 42 healthy children
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 8, 2018

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 8, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share