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
|
|
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
|
|
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. |