Oral Hygiene and Dentition Status among Children with Hemophilia Undergoing Prophylaxis Treatment in a Tertiary Care Hospital in Mumbai, India.

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