| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|