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CTRI Number  CTRI/2024/08/072085 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Dentistry 
Study Design  Other 
Public Title of Study   A Clinical study to explore the correlation between WBCs and Cholesterol Ratio as Biomarker in Chronic Periodontitis patients 
Scientific Title of Study   Assessment of Monocyte-to-High Density Cholesterol Ratio and the Delta Neutrophil Index as potential biomarkers in Chronic Periodontitis: 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  Dr Aarti Yashwant Patil 
Designation  PG Student 
Affiliation  JMFs ACPM Dental College Dhule 
Address  Dept of Periodontology JMFs ACPM Dental College Sakri Road Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9029535551  
Fax    
Email  aartipatil654@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alka Waghmare 
Designation  Head of the Department and PG guide 
Affiliation  JMFs ACPM Dental College Dhule 
Address  Dept of Periodontology JMFs ACPM Dental College Sakri Road Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9423918900  
Fax    
Email  dralkawaghmare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aarti Yashwant Patil 
Designation  PG student 
Affiliation  JMFs ACPM Dental College Dhule 
Address  Dept of Periodontology JMFs ACPM Dental College Sakri Road Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9029535551  
Fax    
Email  aartipatil654@gmail.com  
 
Source of Monetary or Material Support  
JMFs ACPM Dental College, Sakri Road Dhule, Maharashtra, India 424001 
 
Primary Sponsor  
Name  Dr Aarti Patil 
Address  JMFs ACPM Dental College, Sakri Road, Dhule, Maharashtra, India 424001 
Type of Sponsor  Other [Self] 
 
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 Aarti Patil  JMFs ACPM Dental College,Dhule  Dept no 3 Dept of Periodontology and Oral Implantology JMFs ACPM Dental College, Sakri Road, Dhule 424001
Dhule
MAHARASHTRA 		 9029535551

aartipatil654@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JMFS ACPM Dental College Dhule INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinically Healthy Gingiva  Healthy Gingival conditions with no periodontal pocket 
Intervention  Moderate Periodontitis  At least more than two teeth with periodontal pocket depth of more than 3mm and clinical attachment loss of 4mm 
Intervention  Severe Periodontitis  At least more than two teeth with periodontal pocket depth of more than 3mm and clinical attachment loss of more than 5mm 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  1. Within the age group of 25 to 58 years.

2. Patients having at least 20 teeth (not including third molars and teeth with orthodontic appliances, bridges, crowns, or implants).

3. Gingival Index scoring of 0 for clinically Healthy Gingiva.

4. At least ≥2 teeth with one or more sites with probing pocket depth (PD) ≥3 mm and clinical attachment loss (CAL) of 3-4mm for moderate periodontitis and 5mm or more for severe periodontitis.

5. Patients who are willing to participate in the study and given their written consent.
 
 
ExclusionCriteria 
Details  1. Patients having Systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, hepatic diseases, bone metabolic diseases, cardiovascular diseases, lung diseases, malignancies or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
2. Smokers and chronic alcoholic patients.
3. Pregnant or lactating women.
4. Chronic use of NSAIDs and periodontal therapy within the previous 3 months.
5. Patients on lipid lowering drugs.
6. Patients who are not willing to participate
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the Monocyte-to-High Density Cholesterol Ratio and the Delta Neutrophil Index as a potential Biomarker in Chronic Periodontitis Patients.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Chronic Periodontitis on the levels of cholesterol in the body.  Baseline 
 
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)   20/08/2024 
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="1"
Months="0"
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   Assessment of Monocyte-to-High Density Cholesterol Ratio and the Delta Neutrophil Index as potential biomarkers in Chronic Periodontitis patients: A Cross-sectional study.

INTRODUCTION: Chronic periodontitis (CP) is described as an infectious disease resulting in the inflammation of the supporting structures of the teeth with connective tissue attachment loss and alveolar bone loss.

This inflammation of the supporting structures of the periodontium is the mainstay for the pathogenesis of the periodontal disease. The pathogenic bacteria contribute to the spread of the inflammation by its components like lipopolysaccharides which leads to various mechanisms of inflammation. Monocytes which are the largest cells among the leukocytes and contributes to about 2-8% of all the blood cells. They are also the second in line to move to the site of infection. Activated monocytes can produce a number of inflammatory cytokines like tumor necrosis factor-α [TNF-α], Interleukin 1β [IL-1 β] and interleukin-6
              As against HDL [High Density Cholesterol] which has potent anti-inflammatory effect which helps in lowering of activated monocytes, neutrophils and prevent the adhesion of the monocytes to the endothelial wall. Monocyte-to-HDL ratio has been now considered as a potent marker or predictor in many inflammatory conditions like atherosclerosis, cardiovascular diseases, chronic kidney diseases, metabolic syndrome, etc. The fraction of immature granulocytes obtained by subtraction of mature polymorphonuclear leucocytes is the Delta Neutrophil Index. It reflects as a potential blood biomarker as it gives the number of immature neutrophils.

          Therefore, the aim of this study is to assess the Monocyte-to-High Density Cholesterol Ratio and the Delta Neutrophil Index as potential biomarkers in Chronic Periodontitis patients.


METHOD OF SELECTION-The patients satisfying inclusion criteria will be allotted and divided into groups as follows-

Group 1- Clinically Healthy Gingiva

Group 2-Moderate Periodontitis

Group 3- Severe Periodontitis

METHOD OF DATA COLLECTION: At the first visit, all patients will receive a complete dental examination
The nature and purpose of the study will be explained to the patient and informed consent will be obtained

The following clinical parameters will be included;

Gingival Index {GI}

Probing Pocket Depth {PD}

Clinical Attachment Loss{CAL} Venous blood will be collected with the help of 24-gauge needle of 5ml syringe Blood samples will be sent for biochemical analysis for Monocyte, Immature Granulocytes, Neutrophil, Eosinophil count and High-Density Cholesterol levels.
Delta neutrophil index will be calculated as the neutrophil subfraction and the eosinophil subfraction - the PMN subfraction 

            

 
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