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CompletedNCT03457974Updated Mar 8, 2018

Saliva Profiles in Children With Congenital Heart Disease

An interventional study of saliva in Cardiac Disease and Dental Caries, sponsored by Istanbul University. Completed. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-08.

Sponsored by Istanbul University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
3 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Disease
  • Dental Caries

Keywords

  • saliva composition
  • antioxidant activity
  • caries risk factors
  • congenital cardiac disease
03

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 3-12 years
  • Caridac problems

Exclusion criteria

Exclusion Criteria:

  • other ages
  • syndromes
  • other systemic diseases
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    congenital heart disease

    42 patients

    Other: saliva

  • Other
    helathy children

    42 children

    Other: saliva

Interventions

  • Othersaliva

    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.

05

What researchers measure

Primary outcomes

  1. salivary secretion rate

    salivary secretion rate

    Time frame: 2 hour

  2. salivary buffering capacity

    salivary buffering capacity

    Time frame: 2 hour

  3. pH

    pH

    Time frame: 2 hour

Secondary outcomes

  1. protein levels of saliva

    protein levels

    Time frame: 2 hour

  2. superoxide dismutase (SOD)

    superoxide dismutase (SOD)

    Time frame: 2 hour

  3. ferric reducing antioxidant power (FRAP)

    ferric reducing antioxidant power (FRAP)

    Time frame: 2 hour

  4. the thiobarbituric acid reactive substances (TBARS)

    the thiobarbituric acid reactive substances (TBARS)

    Time frame: 2 hour

Other outcomes

  1. protein carbonyl

    protein carbonyl

    Time frame: 2 hour

  2. protein thiols

    protein thiols

    Time frame: 2 hour

  3. total sialic acid

    total sialic acid

    Time frame: 2 hour

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03457974
Lead sponsor
Istanbul University
Collaborators
Figen Seymen, Merve Bayram, Ezel Uslu, Sule Batu, Yegane Güven
Responsible party
Mine Koruyucu (Principal Investigator, Istanbul University) — Principal investigator
First posted
Mar 8, 2018
Start date
Jan 1, 2011
Primary completion
Jan 1, 2012
Completion
Jan 1, 2012
Last update
Mar 8, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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