| CTRI Number |
CTRI/2024/11/076113 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Detection of early tooth decay using oral mouth rinse in children between 7 to 11 years |
|
Scientific Title of Study
|
Evaluating Diagnostic Accuracy of Fluorescent Starch Nanoparticles Oral Rinse in Detection of Early Carious Lesion in Children aged 7 to 11 years – A Cross-Sectional Study |
| 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 Vashi Mitulkumar Narendra |
| Designation |
Postgraduate Student |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
No. 3, Department of Pediatric and Preventive Dentistry, First Floor,
KM Shah Dental College and Hospital, Sumandeep Vidyapeeth,
Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998021650 |
| Fax |
|
| Email |
mitul1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Dave |
| Designation |
Professor and Head of the Department |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
No. 3, Department of Pediatric and Preventive Dentistry, First Floor,
KM Shah Dental College and Hospital, Sumandeep Vidyapeeth,
Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavna Dave |
| Designation |
Professor and Head of the Department |
| Affiliation |
K. M. Shah Dental College and Hospital |
| Address |
No. 3, Department of Pediatric and Preventive Dentistry, First Floor,
KM Shah Dental College and Hospital, Sumandeep Vidyapeeth,
Waghodia, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, At & Po: Piparia, Waghodia Road, Ta: Waghodia, Vadodara, Gujarat, India - 391760 |
|
|
Primary Sponsor
|
| Name |
Dr. Vashi Mitulkumar Narendra |
| Address |
No. 3, Department of Pediatric and Preventive Dentistry, First Floor,
KM Shah Dental College and Hospital, Sumandeep Vidyapeeth,
Waghodia, Vadodara, Gujarat |
| 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 Vashi Mitulkumar Narendra |
K M Shah Dental College and Hospital |
Room No. 3,
Department of Pediatric
and Preventive
Dentistry.
Vadodara
Vadodara
GUJARAT |
9998021650
mitul1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children at risk of developing dental caries or
children with initial signs of dental caries(ICDAS
score 0 to 2) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with age group of 7-11 years showing Frankl Behaviour Rating Scale of 3 and 4.
2. Children with minimum ICDAS II score of 1 or 2.
3. Children who are able to rinse properly. |
|
| ExclusionCriteria |
| Details |
1.Children having hypoplasia, fractures, dentinogenesis imperfecta, amelogenesis imperfecta and other conditions affecting the structural health of the enamel.
2.Children having intrinsic and extrinsic stains.
3.Children who do not give assent and parents who do not give written consent for their child to participate in the study.
4.Children with special health care needs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate Diagnostic Accuracy of Oral Rinse containing Targeted Fluorescent Starch Nanoparticles in Detection of Early Carious Lesion in children aged 7 to 11 years. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a new clinically valid methodology to diagnose early carious lesions that also enables effective monitoring of conservative treatment. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
LumiCareâ„¢ Caries Detection Rinse (GreenMark Biomedical Inc, USA) provides quick and painless, preventive dental care for children. It is a water-based solution containing patented fluorescent sub-micron starch particles that have been functionalized to target and adhere to the subsurface of early-stage carious lesions after penetrating through surface porosities. [14] Implementing early caries detecting oral rinse at the community level is crucial for promoting oral health and preventing dental decay. This proactive approach allows for timely identification of initial tooth decay stages, enabling prompt intervention and treatment. By incorporating such rinses into community oral health initiatives, individuals can detect issues early, leading to more effective management and potentially preventing progression to severe stages. Our ultimate goal is to develop a new clinically valid methodology to diagnose early carious lesions that also enables effective monitoring of conservative treatment. |