HealthyNCT03468946
Investigation of the Relationship Between Taste Perception and Caries Activity in School Children
A study testing salty taste perception, bitter taste perception and sour taste perception in people with Healthy, run by University of Beykent.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- salty taste perception, bitter taste perception and sour taste perception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- chronic disease ASA III, IV antibiotic and drug intake within the last month
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- salty taste perception, bitter taste perception, sour taste perception, sweet taste perception
- Keywords
- taste perception, caries risk, cariogram, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salty taste perceptionOther
Also called sodium chloride, Sigma-Aldrich, USA, RIEDEL SK.S.314
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 ).
bitter taste perceptionOther
Also called caffeine, Merck, Germany, MERCK 102584
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 ).
sour taste perceptionOther
Also called citric acid, Sigma-Aldrich, USA, RIEDEL SK.R.2 7102
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 ).
sweet taste perceptionOther
Also called sucrose, Merck, Germany, MERCK 1.07651.1 000
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 ).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: salty taste perception; Other: bitter taste perception; Other: sour taste perception; Other: 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. Receives: Other: salty taste perception; Other: bitter taste perception; Other: sour taste perception; Other: 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. Receives: Other: salty taste perception; Other: bitter taste perception; Other: sour taste perception; Other: sweet taste perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
Sillness&Löe Index
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
Measured: 1 year
Salivary flow rate
Salivary flow rate in ml/minute
Measured: 1 year
buffer capacity
buffer capacity in pH / DMFT, Plaque index, Salivary flow rate, buffer capacity, mutans streptococci
Measured: 1 year
mutans streptococci and lactobacilli counts
mutans streptococci and lactobacilli counts in cfu/ml / DMFT, Plaque index, Salivary flow
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start2 May 2013
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edibe Egil, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468946
- Sponsor's protocol ID
- SAG-C-DRP-090414-0077
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Taste Perception and Caries Activity in School Children
- ClinicalTrials.gov ID
- NCT03468946
- Acronym / sponsor ID
- SAG-C-DRP-090414-0077
- Conditions
- Healthy
- Keywords
- taste perception, caries risk, cariogram, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 2 May 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high caries risk | Other | Other: salty taste perception, Other: bitter taste perception, Other: sour taste perception, Other: sweet taste perceptionchildren 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. |
| medium caries risk | Other | Other: salty taste perception, Other: bitter taste perception, Other: sour taste perception, Other: sweet taste perceptionchildren 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. |
| low risk | Other | Other: salty taste perception, Other: bitter taste perception, Other: sour taste perception, Other: sweet taste perceptionno 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- chronic disease ASA III, IV antibiotic and drug intake within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salty taste perceptionAlso: sodium chloride, Sigma-Aldrich, USA, RIEDEL SK.S.314salty 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 | high caries risk, low risk, medium caries risk |
| bitter taste perceptionAlso: caffeine, Merck, Germany, MERCK 102584bitter 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 | high caries risk, low risk, medium caries risk |
| sour taste perceptionAlso: citric acid, Sigma-Aldrich, USA, RIEDEL SK.R.2 7102sour 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 | high caries risk, low risk, medium caries risk |
| sweet taste perceptionAlso: sucrose, Merck, Germany, MERCK 1.07651.1 000sweet 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 | high caries risk, low risk, medium caries risk |
Primary outcome
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
4 secondary outcomes
Sillness&Löe Index
Time frame: 1 year
Salivary flow rate
Time frame: 1 year
buffer capacity
Time frame: 1 year
mutans streptococci and lactobacilli counts
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing salty taste perception, bitter taste perception and sour taste perception in people with Healthy, run by University of Beykent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMFT, DMFS, dft and dfs indices (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.