| CTRI Number |
CTRI/2025/04/084443 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess salivary biomarkers for detection of early childhood caries in Autism Spectrum Disorder |
|
Scientific Title of Study
|
Investigating Salivary Biomarkers for Early
Childhood Caries in Autism Spectrum Disorder: A
Proteomic 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 |
SYED FAZIL HASAN |
| Designation |
Postgraduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Lower Ground - Room 9, Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
8190007282 |
| Fax |
|
| Email |
drfazilsyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TANU NANGIA |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Lower Ground - Room 9, Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9999384333 |
| Fax |
|
| Email |
tanunangia.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR TANU NANGIA |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna Dental College |
| Address |
Q Block, Lower Ground - Room 9, Department of Pediatric and Preventive Dentistry, Manav Rachna Dental College, Sector 43, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Phone |
9999384333 |
| Fax |
|
| Email |
tanunangia.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Q block Basement Room 9
Department of Pediatric and Preventive Dentistry
Manav Rachna Dental College
Sector 43
Faridabad
Haryana |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Syed Fazil Hasan |
Manav Rachna Dental College |
Room. 9
Department of Pediatric and Preventive Dentistry
Manav Rachna Dental College
Sector 43
Faridabad
HARYANA |
8190007282
drfazilsyed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children aged under 6 years
Children with Autism Spectrum Disorder
Children with def score 3-4 |
|
| ExclusionCriteria |
| Details |
Normal children
Children with chronic illness/systemic illness
Children with orthodontic appliance
Children whose parent/guardian doesn’t give written consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To identify and compare the levels of KRT3
in Autism Spectrum Disorder children with
and without Early Childhood Caries.
2. To identify and compare the levels of
MUC21 in Autism Spectrum Disorder
children with and without Early Childhood
Caries. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate the salivary proteomic findings
along with other salivary parameters (pH
and weight of saliva) in developing tailored
preventive regime for caries prone children
with Autism Spectrum Disorder |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The onset of ECC can occur as early as the first few years of life, making early detection and intervention crucial for preventing the progression of the disease. Recent studies have shown that children with Autism Spectrum Disorder (ASD) are disproportionately affected by ECC, with factors such as dietary preferences, oral hygiene difficulties and sensory sensitivities potentially exacerbating their risk. Despite this, the mechanisms underlying the higher prevalence of ECC in children with ASD remain poorly understood, and effective diagnostic tools for early detection are lacking. This study aims to investigate the potential of salivary biomarkers as indicators for Early Childhood Caries (ECC) in children diagnosed with Autism Spectrum Disorder (ASD). Specifically, the study employs analysis to identify and characterize the differences in the salivary proteome of children with ECC and those without, with a focus on those with ASD. |