"Comparing Dental Health and Saliva Composition in Children With Thalassemia and Those Without"
- Conditions
- Other specified diseases of bloodand blood-forming organs,
- Registration Number
- CTRI/2025/06/088386
- Lead Sponsor
- Rutika Gawand
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 80
Non Thalassemic diagnosed children in age group of 5 to 12 years Children whose guardians are providing informed consent.
- •Presence of other systemic disease/s.
- •Patient with cognitive impairment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Pediatric and Preventive Dentistry & Department of Pediatrics
🇮🇳Ahmadnagar, MAHARASHTRA, India
Department of Pediatric and Preventive Dentistry & Department of Pediatrics🇮🇳Ahmadnagar, MAHARASHTRA, IndiaDr Rutika GawandPrincipal investigator08999338785rutikarajkumar06@gmail.com