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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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