| CTRI Number |
CTRI/2025/02/080045 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Association of Salivary Catalase Activity and Oxidative Stress in Early Childhood Caries: A Biomarker for Caries Risk
|
|
Scientific Title of Study
|
Comparative Evaluation of Catalase Enzyme
Production In Children With and Without Early Childhood Caries- A Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani |
| Designation |
BDS final year student |
| Affiliation |
Saveetha University |
| Address |
Dept of pediatric dentistry
Saveetha Dental college
Chennai
Thiruvallur TAMIL NADU 600077 India |
| Phone |
6383048909 |
| Fax |
|
| Email |
152101065.sdc@saveetha.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh R |
| Designation |
Senior lecturer |
| Affiliation |
Saveetha university |
| Address |
Dept of pediatric dentistry
Saveetha Dental college
Chennai
Thiruvallur TAMIL NADU 600077 India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ramesh R |
| Designation |
Senior lecturer |
| Affiliation |
Saveetha university |
| Address |
Dept of pediatric dentistry
Saveetha Dental college
Chennai
Thiruvallur TAMIL NADU 600077 India |
| Phone |
9895725236 |
| Fax |
|
| Email |
rameshr.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental college and hospital, No.162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu - 600 077, India. |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental college and hospitals |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramesh R |
Saveetha dental college and hospital |
Dept of pediatric dentistry, floor 5, clinic 28, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 Chennai TAMIL NADU |
9895725236
rameshr.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ECC group |
Salivary catalase activity spectrometric assessment on DMFT index at baseline and 3 months |
| Comparator Agent |
Non ECC group |
Salivary catalase activity, spectrometric assessment. DMFT index at baseline and 3 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3–6 years diagnosed with early childhood caries (ECC) based on the American Academy of Pediatric Dentistry (AAPD) criteria (ECC group).
Caries-free children with no history of dental caries (Non-ECC group).
Participants were recruited from paediatric dental clinics who were accompanied by parents or guardians who gave informed consent.
|
|
| ExclusionCriteria |
| Details |
Children with underlying health conditions or medical issues.
Children with special needs or disabilities.
Children on medications affecting salivary composition.
Children with any oral soft tissue lesions.
Children who had received fluoride treatment in the last 2 weeks. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: Catalase enzyme activity in the saliva of children with and without ECC.at baseline and 3 months |
Primary outcome: Catalase enzyme activity in the saliva of children with and without ECC.at baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DMFT index evaluation for caries experience |
Immediate comparative assessment |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Early Childhood Caries (ECC) is a widespread public health concern, characterised by the rapid progression of dental decay in the primary teeth of young children. Its multifactorial aetiology encompasses dietary habits, oral hygiene practices, the presence of cariogenic microorganisms, and, increasingly, the role of oxidative stress in oral disease development. Oxidative stress occurs when there is an imbalance between reactive oxygen species (ROS) and the body’s ability to neutralise these harmful molecules through antioxidants, which has been identified as a contributing factor in dental caries progression.
Saliva, an essential physiological fluid, contains a complex mix of enzymes, proteins, and antioxidants that contribute to the maintenance of oral health. Among these, catalase (CAT) plays a critical role in mitigating oxidative damage by breaking down hydrogen peroxide—a byproduct of oxidative metabolism—into water and oxygen. Elevated levels of catalase activity have been observed in the presence of inflammatory processes in the oral cavity, and it serves as an early marker of oxidative stress. In children, the antioxidant defence mechanisms present in saliva, including CAT, are essential for protecting against oral disease, particularly in environments prone to oxidative stress, such as carious lesions.
Oxidative stress, primarily initiated by an overproduction of ROS, has been identified as a predisposing factor in the development and progression of dental caries. By impairing the balance between demineralization and remineralization of tooth enamel, oxidative stress can significantly impact the oral environment, leading to caries activity. Saliva’s antioxidant system, including CAT, serves as a first line of defence, reducing the harmful effects of ROS and supporting tissue health.
Recent studies have highlighted the importance of exploring saliva as a diagnostic tool due to its rich composition of enzymes and antioxidants. Catalase, in particular, has garnered attention for its ability to neutralise hydrogen peroxide and protect oral tissues from oxidative damage. Variations in catalase production and activity in saliva can be influenced by several factors, including genetics, age, health status, and environmental exposures.
Despite the growing body of research on oxidative stress and its role in various oral diseases, limited studies have focused on its contribution to ECC, especially in children. Understanding the relationship between catalase activity and ECC could provide valuable insights into the antioxidant defence mechanisms in children and help identify early biomarkers for the disease. This information could be crucial in developing preventive strategies aimed at reducing the burden of ECC through early detection and intervention.
This randomized controlled trial (RCT) aims to compare catalase enzyme production in children with and without ECC. By examining the differences in CAT activity between these two groups, this study seeks to provide a better understanding of the role of oxidative stress in the development of ECC and its potential implications for preventive care. |