| CTRI Number |
CTRI/2025/07/091920 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring how childrens taste perception influences dental caries risk |
|
Scientific Title of Study
|
Correlation Between Four Different Taste Perceptions (Sweet, Salty, Sour and Bitter) and Caries Activity Level in Children Aged 7–12 Years in Belgaum: A Cross-sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAsifa Gazali |
| Designation |
POST GRADUATE |
| Affiliation |
Maratha Mandal N G H Institute of Dental Sciences , Belagavi |
| Address |
Dept. of pediatric and preventive dentistry . room no. 7 , Maratha mandal N G H Institute of dental sciences , Bauxite road, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8618366991 |
| Fax |
|
| Email |
asifagazali15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ramya Pai |
| Designation |
Reader |
| Affiliation |
Maratha Mandal N G H Institute of Dental Sciences , Belagavi |
| Address |
Dept. of pediatric and preventive dentistry . room no. 7 , Maratha mandal N G H Institute of dental sciences , Bauxite road, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8618366991 |
| Fax |
|
| Email |
ramyapai87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAsifa Gazali |
| Designation |
POST GRADUATE |
| Affiliation |
Maratha Mandal N G H Institute of Dental Sciences , Belagavi |
| Address |
Dept. of pediatric and preventive dentistry . room no. 7 , Maratha mandal N G H Institute of dental sciences , Bauxite road, Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8618366991 |
| Fax |
|
| Email |
asifagazali15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of pediatric and preventive dentistry . room no. 7 , Maratha mandal N G H Institute of dental sciences , Bauxite road, Belgavi |
|
|
Primary Sponsor
|
| Name |
DrAsifa Gazali |
| Address |
Dept. of pediatric and preventive dentistry . room no. 7 , Maratha mandal N G H Institute of dental sciences , Bauxite road, Belgavi |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAsifa Gazali |
Maratha Mandal N G H Institute of Dental Sciences |
Room no.7,Department of Pediatric and preventive dentistry ,Maratha mandal N G H Institute of dental sciences Belagavi,Karnataka,India
Belgaum
KARNATAKA |
08618366991
asifagazali15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maratha mandal N G H Institute of dental sciences Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 7–12 years
Systemically healthy
Written informed consent from parent/guardian and verbal assent from child
Cooperative behavior adequate for oral exam and taste testing
|
|
| ExclusionCriteria |
| Details |
Special healthcare needs or systemic illness
On antibiotic or other long-term medication at time of testing
Known gustatory or olfactory disorder
History of recent oral mucosal pathology affecting taste
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between taste perception scores (sweet, salty, sour, bitter) and caries activity using ICDAS-II scoring in 7–12-year-old children |
At baseline during a single visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean number of correct taste identifications per taste modality per group
Concentration threshold at which 50 of group correctly identifies taste
Group-wise comparison (Chi-square) for correct identification at each concentration level
|
At baseline during single visit |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [asifagazali15@gmail.com].
- For how long will this data be available start date provided 31-07-2025 and end date provided 17-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Dental caries is a common chronic disease in children influenced by behavioral and dietary factors. Taste perception is believed to affect food preferences and caries risk. This cross-sectional observational study was conducted among 100 children aged 7-12 years in Belagavi, Karnataka to evaluate the correlation between taste perception ( sweet, salty, sour and bitter) and caries activity level using ICDAS II scoring. Participants were divided into two groups: caries free and caries active. Taste perception was tested using graded taste strips and suprathreshold sprays. The primary outcome was the correlation between taste perception and caries status. Findings suggested that altered taste sensitivity , especially for sweet and bitter, may serve as a behavioral indicator for caries risk assessment. |