NCT03468946

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2013

Typical duration for not_applicable healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

12 months

First QC Date

February 19, 2018

Last Update Submit

March 12, 2018

Conditions

Keywords

taste perceptioncaries riskcariogramchildren

Outcome Measures

Primary Outcomes (1)

  • DMFT, DMFS, dft and dfs indices

    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 Outcomes (4)

  • Sillness&Löe Index

    1 year

  • Salivary flow rate

    1 year

  • buffer capacity

    1 year

  • mutans streptococci and lactobacilli counts

    1 year

Study Arms (3)

high caries risk

OTHER

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.

Other: salty taste perceptionOther: bitter taste perceptionOther: sour taste perceptionOther: sweet taste perception

medium caries risk

OTHER

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.

Other: salty taste perceptionOther: bitter taste perceptionOther: sour taste perceptionOther: sweet taste perception

low risk

OTHER

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.

Other: salty taste perceptionOther: bitter taste perceptionOther: sour taste perceptionOther: sweet taste perception

Interventions

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 ).

Also known as: sodium chloride, Sigma-Aldrich, USA, RIEDEL SK.S.314
high caries risklow riskmedium caries risk

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 ).

Also known as: caffeine, Merck, Germany, MERCK 102584
high caries risklow riskmedium caries risk

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 ).

Also known as: citric acid, Sigma-Aldrich, USA, RIEDEL SK.R.2 7102
high caries risklow riskmedium caries risk

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 ).

Also known as: sucrose, Merck, Germany, MERCK 1.07651.1 000
high caries risklow riskmedium caries risk

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- chronic disease ASA III, IV antibiotic and drug intake within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium ChlorideCaffeineCitric AcidCandySucrose

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 19, 2018

Study Start

May 2, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

March 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share