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CTRI Number  CTRI/2025/11/097113 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of Periodontal Health Status in Patients Having blood pressure With and Without Smoking An Observational Study 
Scientific Title of Study   Assessment Of Periodontal Health Status in Patients Having Hypertension With and Without Smoking: An Observational Study With and Without Smoking An Observational 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 Puniti Bohria 
Designation  BDS student 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  103,104 RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, DIGDOH HILLS HINGNA ROAD NAGPUR 44009

Nagpur
MAHARASHTRA
440019
India 
Phone  09096093470  
Fax    
Email  docneha85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Puniti Bohria 
Designation  BDS student 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  103 104RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE DIGDOH HILLS HINGNA ROAD NAGPUR 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  09096093470  
Fax    
Email  docneha85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Puniti Bohria 
Designation  BDS student 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
Address  103 104 RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE DIGDOH HILLS HINGNA ROAD NAGPUR 440019

Nagpur
MAHARASHTRA
440019
India 
Phone  09096093470  
Fax    
Email  docneha85@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ranjeet Deshmukh Dental College and Research Centre Nagpur 
Address  Digdoh hiils Hingna road Nagpur 440019  
Type of Sponsor  Other [Private Dental College] 
 
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 NEHA DESHPANDE  Ranjeet Deshmukh Dental College and Research Centre Nagpur  103 104 Ranjeet Deshmukh Dental College and Research Centre Hingna Nagpur 440019
Nagpur
MAHARASHTRA 
09096093470

docneha85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Hypertension 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Known cases of Hypertension
Patients having more than 20 functional teeth
 
 
ExclusionCriteria 
Details  Patients suffering from any other systemic diseases except for Hypertension, allergies or drug usage
Pregnant and Lactating women
Subjects who have undergone periodontal therapy in last 6 months

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Their Oral Health assessments will be taken in which detailed periodontal examinations by trained dental professionals to measure Probing Pocket Depth, Clinical Attachment Level, Plaque Index & Gingival Index and Cardiovascular data in which Medical History collection & Blood Pressure measurements will be taken  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2025 
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 Yet Recruiting 
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  

Hypertension is a powerful independent contributor to cardiovascular morbidity and mortality, on average conferring a threefold increase in risk at all ages and in both sexes Changes in clinical, biochemical and pathological variables characterize cardiovascular damage from smoking and hypertension when it acts independently . Smoking increases the risks of vascular damage by increasing sympathetic tone, platelet stickiness and reactivity, free radical production, damage to endothelium, and by surges in arterial pressure. Active smoking is a widely accepted risk factor for cardiovascular disease and is recognized as a major public health problem. Passive smoking, also known as Second-Hand Smoke Exposure (SHSE), is thought to have similar cardiovascular consequences and the risk has been postulated to be equivalent to that of active smoking. Smoking has a dose-dependent effect on periodontium. Poor periodontal health is associated with increased prevalence of hypertension and may have an influence on BP control. Risk factors such as older age, male gender, non-Caucasian ethnicity, smoking, overweight/obesity, diabetes, low socioeconomic status, and poor education have been considered the common denominators underpinning this relationship.

 

 
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