| 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
|
|
|
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 “controlsâ€
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 |