| CTRI Number |
CTRI/2024/03/063682 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study conducted to estimate the number of root decay cases in South Coastal population of India and to determine the causes of it. |
|
Scientific Title of Study
|
Root caries risk assessment through salivary and molecular analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyothi Ashith Shetty |
| Designation |
Ph.D Research Scholar |
| Affiliation |
A B Shetty Memorial Institute of Dental Sciences, Nitte Deemed to be university |
| Address |
Dept. of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences, Nitte Deemed to be University, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480909605 |
| Fax |
|
| Email |
jyothi.21phdd102@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr Mithra N Hegde |
| Designation |
Vice Dean |
| Affiliation |
|
| Address |
Dept. of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences, Nitte Deemed to be University, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845284411 |
| Fax |
|
| Email |
drmithra.hegde@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyothi Ashith Shetty |
| Designation |
Ph.D Research Scholar |
| Affiliation |
|
| Address |
Dept. of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences, Nitte Deemed to be University, Derelakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480909605 |
| Fax |
|
| Email |
jyothi.21phdd102@student.nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Dr Jyothi Ashith Shetty |
| Address |
Dept. of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences, Nitte Deemed to be University, Derelakatte, Mangalore |
| 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 |
| Dr Jyothi Ashith Shetty |
A B Shetty Memorial Institute of Dental Sciences |
Dept of Conservative Dentistry & Endodontics, Room no.3, A B Shetty Memorial Institute of Dental Sciences, Derelakatte, Mangalore -575018
Dakshina Kannada
KARNATAKA |
9480909605
jyothi.21phdd102@student.nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cenral Ethics Committe, Nitte DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Root caries |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- Subjects in the age group of 30- 75 years residing in south coastal region from past 10
years or more. (as per the term South Coastal population included in the Objectives)
- Subjects with 20 or more natural teeth present in the oral cavity.
- Subjects willing to consent to be a part of the study. |
|
| ExclusionCriteria |
| Details |
- Subjects with any oral diseases ( like salivary gland disease)
- subjects on antibiotics or antifungal agents within the last 1 month prior to sample collection.
-Subjects using mouthwashes and lozenges. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| presence of root caries. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| presence of additional root caries |
2 years |
|
|
Target Sample Size
|
Total Sample Size="1062"
Sample Size from India="1062"
Final Enrollment numbers achieved (Total)= "1062"
Final Enrollment numbers achieved (India)="1062" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A cross sectional observational study was conducted to assess the prevalence of root caries in South Coastal population of India with a sample size of 1062. After screening of the subjects for root caries, salivary samples were collected from 47 root caries free and 47 root caries active subjects for salivary analysis. In the next phase of the study, salivary samples were collected from patients with high root caries index and root caries free subjects to determine the bacterial diversity of healthy and carious roots through metagenomic approach. |