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CTRI Number  CTRI/2025/06/088386 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 30/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   "Comparing Dental Health and Saliva Composition in Children With Thalassemia and Those Without" 
Scientific Title of Study   Comparison Of Oral Health Status, Dental Caries Experience, Salivary Sialic Acid and Salivary Total Antioxidant Capacity in Thalassemic Children And Non Thalassemic Children. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutika Gawand 
Designation  Post Graduate Student 
Affiliation  Pravara Institute of Medical Sciences 
Address  Pravara Institute Of Medical Sciences, Loni Tal: Rahata Dist: AhilyanagarState : Maharashtra Pin: 413736.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8999338785  
Fax    
Email  rutikarajkumar06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neeta Padmawar 
Designation  Reader  
Affiliation  Pravara Institute of Medical Sciences 
Address  Pravara Institute Of Medical Sciences, Loni Tal: Rahata Dist: AhilyanagarState : Maharashtra Pin: 413736.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7972800076  
Fax    
Email  opneeta23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rutika Gawand 
Designation  Post Graduate Student 
Affiliation  Pravara Institute of Medical Sciences 
Address  Pravara Institute Of Medical Sciences, Loni Tal: Rahata Dist: AhilyanagarState : Maharashtra Pin: 413736.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8999338785  
Fax    
Email  rutikarajkumar06@gmail.com  
 
Source of Monetary or Material Support  
NIL 
Pravara Institute of Medical Sciences Loni Rahata Ahilyanagar Maharashtra India 413736 
 
Primary Sponsor  
Name  Rutika Gawand 
Address  Pravara Institute of Medical Sciences. Loni Tal: Rahata Dist: Ahilyanagar State: Maharashta India 413736 
Type of Sponsor  Other [self] 
 
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 Rutika Gawand  Department of Pediatric and Preventive Dentistry & Department of Pediatrics   Pravara Institute Of Medical Sciences, Loni Tal: Rahata Dist: AhilyanagarState : Maharashtra Pin: 413736.
Ahmadnagar
MAHARASHTRA 
08999338785

rutikarajkumar06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee PIMS DU Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Non Thalassemic diagnosed children in age group of 5 to 12 years
Children whose guardians are providing informed consent. 
 
ExclusionCriteria 
Details  • Presence of other systemic disease/s.
• Patient with cognitive impairment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Thalassemic patients and their parents are preoccupied with their life-threatening problems arising from the disease and often neglecting the basic preventive dental care. This study would help the patients to take proper care of their oral hygiene as neglection of this may add to existing complications Relation between salivary biomarkers and oral health status in Thalassemic children will help us in preventive dental treatment  Thalassemic children and their parents often overlook oral health due to the burden of systemic illness. This study assesses the relationship between salivary biomarkers and oral health status to highlight the need for preventive dental care. The primary outcome—correlation between salivary biomarkers and oral health indicators—will be assessed at baseline, 4 weeks, and 8 weeks to guide early intervention strategies.












 
 
Secondary Outcome  
Outcome  TimePoints 
This study explores how thalassemia affects oral health & salivary composition. Primary outcomes (biomarker–oral health correlation) will be assessed at baseline, 4 weeks, & 8 weeks. Secondary outcomes include changes in individual parameters over time, aiding in preventive care & screening in thalassemic children.  This study explores how thalassemia affects oral health & salivary composition. Primary outcomes (biomarker–oral health correlation) will be assessed at baseline, 4 weeks, & 8 weeks. Secondary outcomes include changes in individual parameters over time, aiding in preventive care & screening in thalassemic children. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   05/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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  

The dissertation titled "Comparison of Oral Health Status, Dental Caries Experience, Salivary Sialic Acid and Salivary Total Antioxidant Capacity in Thalassemic Children and Non-Thalassemic Children" by Dr. Rutika Rajkumar Gawand, a postgraduate student in the Department of Pediatric and Preventive Dentistry at Rural Dental College, Loni, aims to assess and compare various oral health parameters and salivary biomarkers between children diagnosed with thalassemia and their healthy counterparts. Thalassemia is an inherited blood disorder that causes defective hemoglobin synthesis, leading to chronic anemia and systemic complications. In pediatric patients, the disease often manifests with oral and craniofacial abnormalities, including maxillary enlargement, malocclusion, and a higher risk of dental caries. These complications are often exacerbated by altered salivary composition and reduced oral hygiene maintenance.

This analytical case-control study will include 80 children aged 5 to 12 years—40 thalassemic and 40 non-thalassemic healthy children. The study will be conducted over two years within the facilities of the Department of Pediatric and Preventive Dentistry, the Department of Pediatrics, and the College of Biosciences and Technology, all under the Pravara Institute of Medical Sciences, Loni. The research objectives focus on evaluating and comparing oral hygiene status, caries experience, and key salivary biomarkers such as flow rate, pH, sialic acid levels, and total antioxidant capacity using non-invasive methods. These biomarkers will be assessed through spectrophotometric and pH-based analyses.

The study is based on the hypothesis that thalassemic children exhibit poorer oral health, increased dental caries, and altered salivary composition in comparison to healthy children. The results are expected to highlight the significance of incorporating oral health surveillance and preventive care into the routine management of thalassemic patients. The non-invasive nature of salivary diagnostics provides an efficient and safe means for early detection of oral health risks in medically compromised children. Through this study, the investigator aims to bridge the gap in understanding the oral-systemic link in thalassemia and emphasize the need for integrated dental care approaches in pediatric hematology.

 
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