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CTRI Number  CTRI/2024/03/063443 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To study the effect of factor replacement therapy on oral hygiene in hemophilic patients 
Scientific Title of Study   Oral Hygiene and Dentition Status among Children with Hemophilia Undergoing Prophylaxis Treatment in a Tertiary Care Hospital in Mumbai, India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nanda Pai  
Designation  Professor and Head Department of Dentistry 
Affiliation  Seth GSMC and KEMH Mumbai 
Address  Department of Dentistry 104 first floor Main building Seth GSMC and KEM Hospital
Acharya Donde Marg Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  9820340680  
Fax    
Email  nandapai@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaya Chaudhari Gunjal 
Designation  Assistant Professor Department of Clinical Pharmacology 
Affiliation  Seth GSMC and KEMH Mumbai 
Address  Department of clinical Pharmacology 1st floor New Multistoreyed Building Seth GSMC and KEM Hospital
Acharya Donde Marg Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  8097092722  
Fax    
Email  vijugmc@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vijaya Chaudhari Gunjal 
Designation  Assistant Professor Department of Clinical Pharmacology 
Affiliation  Seth GSMC and KEMH Mumbai 
Address  Department of clinical Pharmacology 1st floor New Multistoreyed Building Seth GSMC and KEM Hospital
Acharya Donde Marg Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  8097092722  
Fax    
Email  vijugmc@yahoo.co.in  
 
Source of Monetary or Material Support  
Seth GS Medical college and KEM hospital, Mumbai, Maharashtra India 400012 
 
Primary Sponsor  
Name  Seth GS Medical College and KEM Hospital 
Address  Department of Dentistry, 104, First floor, OPD building, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijaya Chaudhari Gunjal  Seth GS Medical College and KEM Hospital Mumbai  Department of Dentistry 104 first floor Main building Acharya Donde Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 
8097092722

vijugmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC3 Seth G S medical college and KEM hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D67||Hereditary factor IX deficiency, (2) ICD-10 Condition: D66||Hereditary factor VIII deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  15.00 Year(s)
Gender  Male 
Details  1. Hemophilic children diagnosed by hematology
2. Age six months to fifteen years
3. No other systemic disease
First three inclusion criteria and patients receiving prophylaxis for Hemophilia at KEMH
for at least 3 months will be considered as CASES
First three inclusion criteria and patients NOT receiving prophylaxis for Hemophilia but
regularly followed up at KEMH will be considered as CONTROLS 
 
ExclusionCriteria 
Details  Children with Von Willebrand Disease (VWD) or any other bleeding disorder
Key information not available in the medical records
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oral Hygiene status by Simplified Oral Hygiene Index (OHI-S) and Dentition status by assessed by visual examination only according to World Health Organization
criteria
 
3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Brushing habits  3 months 
Fear of brushing  3 months 
Fear of dental treatment  3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Objectives 1.To compare the oral hygiene and dentition status in hemophilic children with prophylaxis versus without the prophylaxis  2. To study the frequency and fear of brushing/ dental treatment in hemophilic children with prophylaxis versus without the prophylaxis 

Methods:  Ethics- The study will be carried out in accordance with the guidelines of the Indian Council of Medical Research [2017] and Central Drug Standard Control Organization [CDSCO] Good Clinical Practice Guidelines (GCP) [2001) that have their origins in the Declaration of Helsinki [2013]. All study records will be kept confidential. Identity of the participant will not be revealed except as required by law. 

Study design and setting The study will be a retrospective case control study based on medical records available in the Department of Dentistry of a tertiary care hospital affiliated with a medical college. 

Eligibility criteria: A. Inclusion Criteria: 1. Hemophilic children diagnosed by hematology 2. Age six months to fifteen years 3. No other systemic disease
a. First three inclusion criteria and patients receiving prophylaxis for Hemophilia at KEMH for at least 3 months will be considered as “cases” 
b. First three inclusion criteria and patients NOT receiving prophylaxis for Hemophilia but regularly followed up at KEMH will be considered as “controls” 

Study Procedures: Clinical records maintained in the Department of Dentistry of hemophilia patients who sought dental treatment will be accessed. Relevant data from eligible records will be extracted using the data extraction form (DCF). No personal identifiers will be collected and the data in the DCF will be anonymized. Data entry will be done in Microsoft Excel (Publisher: Microsoft Corporation, Redmond, Washington, USA, 2016) using password protected computers and will  be shared with our collaborators as Excel sheets. Strict patient confidentiality will be maintained throughout. 

Variables: The data will be collected on the following domains: 
1. Demographic characteristics: age, gender, residence, family history, consanguinity 
2. Medical history- presenting symptoms, date of diagnosis, prophylaxis treatment [duration & dosage], phenotypic severity, Inhibitor status, First episode of bleeding, age of diagnosis, comorbidities [if any] 
3. Dental history: presenting symptoms, intraoral bleeding episodes 
4. Oral Hygiene status: Simplified Oral Hygiene Index (OHI-S)
5. Dentition status: assessed by visual examination only according to World Health Organization criteria
6. Brushing habits- frequency of brushing, type of brush, fear of brushing, type of tooth paste, and fear of dental treatment 

Sample size: Total N=120 [60 cases and 60 controls]. 

Anticipated outcomes The results from this study will be used to help investigators to understand the association of prophylactic treatment and the oral hygiene in hemophilic patients, patients’ attitude towards oral hygiene, which will further help the policy makers to address the important aspects of the oral hygiene and impacting the personal benefit of the hemophilic patients
 
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