To

The Convener, IEC-SIBAR,

Takkellapadu, Guntur.
Project Title: Prevalence and Occupational Transmission Risk of Hepatitis B, Hepatitis
C, and Human Immunodeficiency Virus (HIV) Among Dental Patients in a Teaching
Hospital Setting

Department of: Oral maxillofacial surgery

Sibar Institute of Dental Sciences, Guntur.
Purpose of the study:-Short Term Studies (STS)
Principal Investigator
Name : Ryan Hu
nd
Affiliation : 2 year Bds undergraduate SIDS
Email : ryanhu198484@gmail.com
Mobile .No : 8121204512
Guide Name : Dr.
Affiliation :
Email :
Mobile No. :
Duration of the study : 18 to 24 months
Sponsors (if any details) :
Approval from any other ethics / regulatory committee (if required) :

We shall follow the Good Clinical Practice guidelines and the approved protocol in
conducting the research project. Further, we declare that any sort of inclusion of text or
pictorial material which amounts to plagiarism will be avoided. In case of any serious
adverse events, I/We shall bring it to the notice of IEC-SIBAR

Signature of the Investigator(s) Ryan Hu

Signature of the Co-Investigator(s) Dr.

The proposal has been verified as per the requirement mentioned in the information
broacher and forwarded to the IEC-SIBARfor approval. Synopsis of the project,
Informed consent form, Case record form and Study flow chart are enclosed.

Signature of the HOD

(With full name and rubber stamp)

(For IEC office use)Proposal No. Date:

 SYNOPSIS OF THE PROPOSAL

Title: Prevalence and Occupational Transmission Risk of Hepatitis B, Hepatitis C, and

Human Immunodeficiency Virus (HIV) Among Dental Patients in a Teaching Hospital
Setting

Principal Investigator: Ryan Hu

Department of Oral maxillofacial surgery

Sibar Institute of Dental Sciences, Guntur

Introduction: Healthcare professionals, particularly dental personnel, are routinely

exposed to infectious agents due to the nature of their work involving frequent contact
with blood and saliva. Among these, blood-borne pathogens such as hepatitis B virus
(HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) pose
significant risks through percutaneous (needle-stick, sharp injuries) and mucocutaneous
exposures. Dental professionals are at a heightened risk due to aerosol generation, sharp
instruments, and complex procedures within a confined operative field.

In low- and middle-income countries, data regarding the actual seroprevalence of these
viruses among dental patients is limited. Even less is known about their occupational
transmission to dental personnel, leading to an underestimation of the real threat.
Understanding the prevalence in patients and identifying specific occupational risk
factors is crucial for formulating preventive strategies and modifying infection control
protocols.

This study is rooted in the dual objective of establishing baseline prevalence data and
examining real-world scenarios of transmission risks in a high-volume academic setting.

Hypothesis:
Null (H₀): No significant seroprevalence or occupational transmission of HBV, HCV, or
HIV.
Alternative (H₁): Significant seroprevalence exists with measurable occupational
transmission risk.

Procedures:

Serological testing (ELISA + rapid kits) for HBsAg, anti-HCV, and HIV ½ antibodies.

Real-time logging and follow-up of exposure incidents among staff over 6 months.

Sample Size: ~400 patients; 50 dental personal

Sampling: Stratified random sampling for patients; consecutive sampling for exposures.

Ethical Considerations:

IEC approval and informed consent required.

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Anonymity, voluntary participation, and data security ensured.

Free testing and PEP offered post-exposure.

Monitoring at 6 weeks, 3 months, and 6 months post-exposure if needed

Data Analysis:

Software: SPSS v25, R.

Descriptive statistics for prevalence and injury frequency.

Inferential analysis via chi-square, logistic regression, Kaplan-Meier survival, Fisher’s

exact test.

Significance: p < 0.05.

Primary Objectives:

To determine the seroprevalence of HBV, HCV, and HIV among patients attending a
teaching dental hospital.

To document the incidence and characteristics of percutaneous and mucocutaneous

injuries among dental personnel.

Secondary Objectives:

To identify factors associated with increased risk of occupational exposure and potential
transmission.

To analyze current preventive protocols and assess compliance levels in the hospital

Materials &Methods: To ensure accuracy, reliability, and standardization across all

procedures, the following materials and equipment will be utilized:

1. Diagnostic Materials for Serological Testing (Patients):

Vacutainers and Needles (5 mL): Sterile, single-use blood collection tubes with EDTA
and plain variants for serum separation.

Tourniquets and Alcohol Swabs: For aseptic venipuncture.

Centrifuge Machine: For serum separation prior to testing.

ELISA Kits:

HBsAg ELISA (3rd generation) – [Specify brand, e.g., J. Mitra or Bio-Rad]

Anti-HCV ELISA – WHO prequalified or ICMR-approved kit

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HIV 1 & 2 Antibody ELISA – 4th generation, CE/ICMR certified

Rapid Immunochromatographic Test Kits:

For HBsAg, Anti-HCV, HIV 1 & 2 – used for preliminary screening and in urgent
reporting situations.

Micropipettes (1–1000 µL): For precise reagent handling.

Incubator (37°C): For incubation of ELISA plates.

ELISA Plate Reader and Washer: For quantitative absorbance reading of serological
results.

2. Personal Protective Equipment (PPE) for Personnel:

Nitrile gloves (powder-free, latex-free)

N95 or triple-layer surgical masks

Protective face shields and goggles

Disposable gowns and aprons

Shoe covers and surgical caps

3. Exposure Incident Documentation and Monitoring Tools:

Standardized Exposure Incident Reporting Forms (pre-printed and digital versions)

Post-Exposure Monitoring Charts for follow-up documentation

Vaccination Status Forms (HBV titers and booster tracking)

Serological Testing Kits for Follow-up:

Rapid tests and ELISA kits for HBV, HCV, HIV monitoring of dental personnel

4. Disinfection and Emergency Response Materials:

70% Isopropyl alcohol

0.5% Sodium hypochlorite solution for surface decontamination

Sterile saline and water for wound irrigation

First-aid kits at chairside

HIV Post-Exposure Prophylaxis (PEP) kits (e.g., tenofovir + lamivudine + efavirenz)

Hepatitis B vaccine and immunoglobulin vials (if required)

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5. Data Collection and Management Tools:

Structured Proformas:

Patient Screening Form

Consent Forms (ICF)

Exposure Logs

Follow-up Checklists

Potential Risks and Benefits:

Risks include accidental needle-stick injuries, mucocutaneous exposures, and psychological
stress from seropositive findings.
Minimal discomfort during blood collection may occur.
Immediate care and post-exposure prophylaxis will be ensured.
Benefits include early diagnosis of HBV, HCV, and HIV in patients.
The study enhances safety protocols and informs preventive strategies for dental personnel.

Statistical analysis:
Data will be entered into Microsoft Excel and analyzed using SPSS version 25.
Simple percentages will be calculated for HBV, HCV, and HIV prevalence.
Bar charts and pie charts will be used to show exposure types and frequency.
Chi-square test will check if exposure risk varies by department or staff level.
A p-value less than 0.05 will be considered statistically significant.

Reference:
1. WHO. (2023). Global hepatitis report. Geneva: World Health Organization.
2. CDC. (2022). Guidelines for Infection Control in Dental Health-Care Settings.
3. ICMR. (2017). National Ethical Guidelines for Biomedical . and Health Research.
4. Shaghaghian S et al. (2020). “Occupational Exposure to Blood-Borne Pathogens
among Dental Students and Interns.” BMC Oral Health.
5. Prüss-Üstün A et al. (2005). “The global burden of disease from sharps injuries to
health-care workers.” Bull WHO.
6. Khosravi SH et al. (2015). “Hepatitis B vaccination status and needle-stick
injuries among dental personnel in Iran.” J Infect Dev Ctries.
7. Grobler SR et al. (2021). “HIV seroprevalence in dental patients: A cross-
sectional study.” Int J Infect Dis.

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 STUDY FLOW CHART

Title: Prevalence and Occupational Transmission Risk of Hepatitis B, Hepatitis C, and

Human Immunodeficiency Virus (HIV) Among Dental Patients in a Teaching Hospital
Setting

Principal Investigator: Ryan Hu

Department of Oral maxillofacial surgery

Sibar Institute of Dental Sciences, Guntur

PATIENTS ATTENDING OPD

Informed Consent & Questionnaire

Blood Sample Collection for ELISA Testing

(HBsAg, Anti-HCV, HIV 1 & 2 Antibodies) – Same Day Report

Seropositive Cases Documented and Coded Anonymously

DENTAL PERSONNEL INCIDENT MONITORING

(Percutaneous / Mucocutaneous Injury Log Maintained)

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 |

Immediate Care + Vaccination/PEP as per Guidelines

Longitudinal Follow-up at if necessary

Data Entry → Statistical Analysis → Final Reporting

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 INFORMED CONSENT FORM (ICF) Confidential
ID No. __________

Title: Prevalence and Occupational Transmission Risk of Hepatitis B, Hepatitis C, and

Human Immunodeficiency Virus (HIV) Among Dental Patients in a Teaching Hospital
Setting Principal Investigator: Ryan Hu
Department of. Oral maxillofacial surgery
Sibar Institute of Dental Sciences, Guntur

Name: Gender: Age:

Address:

Having been informed about the aim, objectives and the procedure of the said research
project, I am agreeing to reveal information required for the research and allowing the
investigator and his team to utilize my blood and CSF sample for the same purpose without
disclosing my identity. I also understand that the participation is completely voluntary and I
can withdraw myself from the study anytime without assigning any reason and this will not
affect my ongoing and future treatment.
నాకు పరిశోధన యొక్క లక్ష్యం మరియు విధి విధానములన్నిటి గురించి పరిశోధన
బృందంచే విశదీకరిండం అయింది. వారికి కావలసిన సమాచారము స్వచ్చందంగా
తెలియజేయుచున్నాను. నా వ్యక్తిగత వివరములు బయటపెట్టకుండా నేను ఇచ్చిన
సమాచారము, నా శరీరము నుండి మస్తిష్కమేరుద్రవమ మరియురక్తంపరిశోధన నిమిత్తం
ఉపయోగించుటకు నేను మనస్పూర్తిగా అంగీకరిస్తున్నాను. ఇందులో నాపై ఎవరి
వత్తిడి లేదు. అంతేగాకుండా నేను ఏ కారణము చేతనైనను ఎప్పుడైనను ఈ పరిశోధన
నుండి వైదొలగే అవకాశం కూడా నాకు కలదు. నేను పూర్తి తెలివితో
స్వచ్చందంగా ఈ అంగీకారము తెలుపుచున్నాను.

Signature of Witness Signature of the Participant

సాక్షి సంతకం పాల్గొన్నవారి సంతకం

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 ID No.
CASE RECORD FORM (CRF) ______________

Title: Prevalence and Occupational Transmission Risk of Hepatitis B, Hepatitis C, and

Human Immunodeficiency Virus (HIV) Among Dental Patients in a Teaching Hospital
Setting

Principal Investigator: Ryan Hu

Department of Oral Maxillofacial surgery

Sibar Institute of Dental Sciences, Guntur

Questionire

Institution Logo/Header]

Patient Medical History Questionnaire – Blood-Borne Viral Infections Study

Teaching Dental Hospital – Confidential Document

Study Title: Seroprevalence and Transmission Risk of Hepatitis B, C, and HIV among Dental Patients

Participant ID: ___________ Date: //20___

Consent Obtained: Yes / Nn

Section A: Demographic Information

1. Full Name: _____________________________________

2. Age: _______ Gender: ☐ Male ☐ Female ☐ Other

3. Occupation: _____________________________________

Section B: Medical History

4. Have you ever been diagnosed with:

☐ Hepatitis B ☐ Hepatitis C ☐ HIV/AIDS ☐ None

If yes, year of diagnosis: ____________

Are you currently undergoing treatment? ☐ Yes ☐ No

5. Have you been vaccinated for Hepatitis B?

☐ Yes ☐ No ☐ Not Sure

If yes, approximate year: ___________

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6. Have you ever undergone any of the following medical procedures? (Tick all that apply)

☐ Blood transfusion ☐ Organ transplant ☐ Dialysis

☐ Chemotherapy ☐ Tattoos / Body Piercing

☐ Dental extraction or surgery ☐ None

7. Do you have a history of:

☐ Intravenous drug use

☐ Unprotected sexual contact with multiple partners

☐ Needle-stick injuries (occupational or non-occupational)

☐ History of STD/STI

☐ None of the above

Section C: Symptoms and Clinical Indicators

8. Do you currently or have you recently experienced any of the following?

☐ Jaundice (yellowing of eyes or skin)

☐ Chronic fatigue

☐ Unexplained weight loss

☐ Swollen lymph nodes

☐ Frequent infections or fever

☐ None

9. Are you aware of any family member diagnosed with:

☐ Hepatitis B ☐ Hepatitis C ☐ HIV ☐ None

Section D: Consent & Acknowledgment

I understand that my participation is voluntary and my information will remain confidential.

I consent to have my blood tested for Hepatitis B, Hepatitis C, and HIV antibodies for this study.

Signature of Participant: ___________________________

Date: //20___

Signature of Investigator: _________________________

Signature of Person Collecting Data

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 GUIDELINES TO FILL THE APPLICAION FORM
The application form is to be neatly typed with Times New Roman, 12 font size. The original
is to be signed in each page by the investigator and properly numbered for page as shown.
Original and 9 copies of filled proposal forms are to be submitted to Dr. B.V. Ramana Reddy
soft copy of the proposal in word format to be mailed to iec.sibar@gmail.com

Synopsis
INTRODUCTION : Briefly introduce the topic with its importance.
REVIEW OF LITERATURE: National status, International status, Why this work is important
AIMS AND OBJECTIVES: Hypothesis, Aim of the proposal, Specific objectives.
MATERIALS & METHODS:Subjects (Sources), Sample size / duration, Inclusion and exclusion
criteria point wise. Procedures to be followed in the study (with references)
POTENTIAL RISKS AND BENEFITS: Mention the potential risks in the study and the probable
benefits of the study.
STATISTICAL ANALYSIS:Outline the parameter to be studied. Mention the type of data to be
collected. Exact statistical tests to be employed for analysis.Mention the level of significance.
REFERENCE :Papers already cited in Review and Methods in Vancouver style.

Study Flow Chart

How the work is planned to be executed. Which should include -Recruitment of the subject
and Enrollment - Selection of patients as per the inclusion-exclusion criteria - Making study
groups - Study Procedures - Data collection - Statistical analysis – Conclusion (Expected
outcome). Recruitment and enrollment of patient or volunteer require advertisement and
payment.Is it true for your study? If not omit these points.

Informed Consent Form

The IFC form may contain all the information like: Mob. No.; address of the patient; Bed No.;
IP or OP No.; Admission date; Medico legal Case No and other details of the patient but
required for the study; as it is confidential.
The meaning of English and Telugu version of consent form must be same.
The IFC form can be modified to suit your objective.

Case Record Form

Must be designed and structured to suit your study.
Must record information only related to the objectives of the study.
No disclosure of participant’s detail which may lead to disclosure of identity.Instead of
address you may think of- Urban/ rural/ Semi-urban.

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