- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03468946
Investigation of the Relationship Between Taste Perception and Caries Activity in School Children
Four basic taste perceptions and relationship with caries are poorly investigated in children as compared to adults.
The aim of this study was to evaluate salty, sweet, bitter and sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
Study Overview
Status
Conditions
Detailed Description
Study design
Caries risk assessment The investigators developed a questionnaire to understand the patient's overall health status, to collect demographic and socio-economic information, to assess their oral health habits. The questionnaire consists of 3 parts; first part includes questions about general health such as chronic diseases, drugs and allergies, second part includes questions about income and education level of parents, and last part includes questions about oral health knowledge, habits, diet contents and frequency, fluoride exposure. the investigators allowed the parents to fill the questionnaire.
After the questionnaire was filled, the investigators performed the oral examination using DMFT, DMFS, dft and dfs indices according to WHO. Then, the investigators determined the oral hygiene status with Sillness&Löe Index (Silness ve Loe, 1964). the investigators estimated paraffin-stimulated salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts using CRT chairside kits (Ivoclar Vivadent, Schaan, Liechtenstein).
In addition to initial questionnaire and oral examination, the investigators asked the patients to record their nutritional takings of 2 weekdays and 1 weekend day. the investigators estimated the caries risk profiles of all children using the Cariogram which is a computer-based program. Cariogram identifies three risk groups low, medium and high caries risk according the scores.
- Taste evaluation the investigators prepared aqueous basic taste solutions of sucrose (Merck, Germany, purity >99.5%), sodium chloride (Sigma-Aldrich, USA, purity >99%), caffeine (Merck, Germany, purity >99.5%), citric acid monohydrate (Sigma-Aldrich, USA, purity >99%), at two levels (1.0 ISO, 2.0 ISO) (ISO 3972:1991, 8586-1:1993) (Table 1). the investigators formulated all the solutions by using spring water in the same day of measurement at room temperature (25 ± 2°C). Each solution was coded randomly.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- without any chronic disease such as diabetes and being ASA I or ASA II. We only included patients who had no antibiotics and drug intake within the last month.
Exclusion Criteria:
- chronic disease ASA III, IV antibiotic and drug intake within the last month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: high caries risk
children with high caries -identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
|
salty taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).
Other Names:
bitter taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sour taste perception in high caries risk, medium caries risk, low caries risk.
The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sweet taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
|
|
OTHER: medium caries risk
children with medium caries- identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
|
salty taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).
Other Names:
bitter taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sour taste perception in high caries risk, medium caries risk, low caries risk.
The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sweet taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
|
|
OTHER: low risk
no caries or low risk- identified by cariogram to evaluate sweet taste perception, salty taste perception, sour taste perception and bitter taste perception of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors.
|
salty taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk ).
Other Names:
bitter taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sour taste perception in high caries risk, medium caries risk, low caries risk.
The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
sweet taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DMFT, DMFS, dft and dfs indices
Time Frame: 1 year
|
DMFT, DMFS, dft and dfs indices are total counts of decayed, missing, filled teeth / DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts are combined to report caries risk in high/medium/low caries risk
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sillness&Löe Index
Time Frame: 1 year
|
Sillness&Löe index in total amount of dental plaque on the teeth.
/DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci and lactobacilli counts are combined to report caries risk in high/medium/low caries risk
|
1 year
|
|
Salivary flow rate
Time Frame: 1 year
|
Salivary flow rate in ml/minute
|
1 year
|
|
buffer capacity
Time Frame: 1 year
|
buffer capacity in pH / DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci
|
1 year
|
|
mutans streptococci and lactobacilli counts
Time Frame: 1 year
|
mutans streptococci and lactobacilli counts in cfu/ml / DMFT, Plaque index, Salivary flow
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Anticoagulants
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Chelating Agents
- Sequestering Agents
- Central Nervous System Stimulants
- Calcium Chelating Agents
- Caffeine
- Citric Acid
Other Study ID Numbers
- SAG-C-DRP-090414-0077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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