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CTRI Number  CTRI/2026/01/102369 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of iron containing supplement on teeth of children 
Scientific Title of Study   Effect of iron containing supplement on teeth of children: A cross sectional study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RATHI POOJA DINESH 
Designation  Lecturer 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur  
Address  Room No. 301, Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  07588435425  
Fax    
Email  poojar018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PINJARKAR ADITI 
Designation  Student 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  Room No. 301, Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  07588435425  
Fax    
Email  abeerdentalclinic@gmail.com  
 
Details of Contact Person
Public Query  
Name  RATHI POOJA DINESH 
Designation  Lecturer 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur  
Address  Room No.301, Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  07588435425  
Fax    
Email  poojar018@gmail.com  
 
Source of Monetary or Material Support  
Pooja Rathi, VSPMs DCRC, Nagpur, India 440019 
 
Primary Sponsor  
Name  RATHI POOJA DINESH 
Address  301, Department of pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India 
Type of Sponsor  Other [RATHI POOJA DINESH] 
 
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 Pooja Rathi  Ranjeet Deshmukh Dental College and Research Centre Nagpur  Room No. 301, Department of Pediatric and Preventive Dentistry, NAGPUR 440019
Nagpur
MAHARASHTRA 		 07588435425

poojar018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  taking iron supplementation 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Healthy children between the ages of 3-15 who were prescribed oral iron supplementation in syrup form from 1 to 6 months 
 
ExclusionCriteria 
Details  Uncooperative and systemically ill children were excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Baseline: Effects of iron supplements on teeth of children will be recorded by using modified stain index   Baseline
No follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Baseline assessment of effects of iron supplementation on teeth of children  Baseline assessment of effect of iron supplements on teeth of children  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Aim:

To evaluate the effects of iron containing supplements on teeth of children           

 

Settings and Design:

The study was conducted in a hospital setting, involving pediatric outpatient and inpatient departments. Participants included 60 children, aged 3-15 years, grouped based on the duration of iron supplement use, ranging from one to six months.

 

Methods and Material:

Participants underwent dental examinations using the Modified Stain Index, which classified stains based on intensity and surface coverage. Data on oral hygiene practices, such as brushing frequency and technique, were collected.

 

Statistical Analysis:

Chi-square tests determined the association between supplementation duration and staining severity, with a significance level of p < 0.05.

 

Results:

The study found a positive correlation between supplement duration and stain intensity, with 71.7% of participants exhibiting some level of staining. Children with infrequent brushing habits had more intense stains, while those with better hygiene practices showed reduced staining.

 

Conclusions:

Iron-containing syrups contribute to dental staining in children, especially with prolonged use. Enhanced oral hygiene practices, including regular brushing, may help mitigate these effects, underscoring the need for preventive counseling by healthcare providers.

 
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