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CTRI Number  CTRI/2025/05/086832 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Analysis of Salivary compounds in patients with gum disease having high Blood pressure  
Scientific Title of Study   Estimation of Salivary volatile organic compounds in hypertensive subjects with periodontitis using Gas chromatography- Mass Spectrometry 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lipika Gopal 
Designation  Reader 
Affiliation  manav rachna dental college 
Address  Department of Periodonology Manav rachna dental college Sector 43, Aravalli hills Surajkund Badhkal road Faridabad

Faridabad
HARYANA
121004
India 
Phone  9717546141  
Fax    
Email  lipikagopal@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Lipika Gopal 
Designation  Reader 
Affiliation  manav rachna dental college 
Address  Department of Periodonology Manav rachna dental college Sector 43, Aravalli hills Surajkund Badhkal road Faridabad

Faridabad
HARYANA
121004
India 
Phone  9717546141  
Fax    
Email  lipikagopal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Lipika Gopal 
Designation  Reader 
Affiliation  manav rachna dental college 
Address  Department of Periodonology Manav rachna dental college Sector 43, Aravalli hills Surajkund Badhkal road Faridabad

Faridabad
HARYANA
121004
India 
Phone  9717546141  
Fax    
Email  lipikagopal@yahoo.com  
 
Source of Monetary or Material Support  
Manav Rachna Dental College, SDS, MRIIRS, Sector 44, Aravalli hills, Delhi-Surajkund Road Pin Code-121002 
 
Primary Sponsor  
Name  Manav Rachna Dental college 
Address  Manav Rachna Dental College Sector 44 Aravali hills, Delhi-Surajkund Road - 121002 
Type of Sponsor  Research institution 
 
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 
Lipika Gopal  Manav Rachna Dental College, MRIIRS  Manav Rachna Dental College, Sector 44 Aravalli hills, Delhi-Surajkund Road, Pin code-121002
Faridabad
HARYANA 
9717546141

lipikagopal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional 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, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non surgical periodontal therapy  Scaling and Root planing 
Comparator Agent  Pre-hypertensives with periodontitis  Scaling and root planing 
Comparator Agent  Stage I hypertensives with periodontitis  Scaling and root planing 
Comparator Agent  Stage II hypertensives with periodontitis  Scaling and root planing 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Group A Pre-Hypertensive periodontitis subjects

1.Generalised periodontitis
2.Age between 30 to 60 years
3.Bleeding on probing <10%
4.Pre-hypertension subjects according to AHA classification
5.Patient willing to participate in the study
Group B- Stage I Hypertensive periodontitis subjects

1. Generalized periodontitis
2. Age between 30 to 60 years
3.Stage I Hypertension according to AHA guidelines
4.Patient willing to participate in the study

Group C- Stage II Hypertensive periodontitis subjects

1. Generalized periodontitis
2. Age between 30 to 60 years
3. Stage II hypertension according to AHA guidelines
4.Patient willing to participate in the study
 
 
ExclusionCriteria 
Details  1. Periodontal therapy last 3 months.
2. Antibiotics in last 3 months.
3. Pregnant and lactating females.
4. Subjects using any form of tobacco.
5. History of nasal obstructions and mouth breathers
6. History of known systemic diseases except hypertension
7. History of use of mouthwashes
8. Subjects using Dental prosthesis
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The present study is undertaken to facilitate investigation to clarify the
role of volatile organic compounds measurement with the help of GC-MS in causing oral
malodour in obese hypertensive subjects with and without periodontitis. 
The recording of clinical parameters , saliva collection and estimation of volatile sulphur compounds measurement with the help of GC-MS at baseline and 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the salivary VOC levels and clinical parameters in
hypertensive with periodontitis subjects among all groups using GC-
MS. 
1 month 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   19/05/2025 
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="2"
Months="6"
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  

Saliva is non-invasive and easily accessible fluid. It consist of volatile and non-volatile organic compounds responsible for the breath malodour. Halitosis/Breath malodour is an unpleasant smell from oral cavity.This originates from volatile sulphur compounds especially hydrogen sulphide, methyl mercaptan. Proteolytic degradation of sulphur and non sulphur containing amino acids by oral microorganisms in saliva, leads to release of malodorous compounds. The volatile organic compounds such as 1-Tetradecanol, 1-Hexadecanol, Toluene, Butylated hydroxytoluene and Dotriacontane are the products detected in saliva, breath and tongue-coating samples which is responsible for oral malodor. These compounds which are responsible for oral malodour are not observed in published studies in hypertensive patients with periodontitis because of difficulty in identification and quantification leading to exhaustive laboratory procedures. The putative pathogens responsible for periodontal disease are considered to be the prime causative factors for production of VOC causing oral malodour. Considering that periodontitis and hypertension share common risk factors,  the confounding factors must be controlled when assessing the association of these outcomes. Given the lack of published studies that have investigated the quantity of oral malodourous compounds in hypertensive subjects with or without periodontitis,this study is undertaken to evaluate malodourous compounds hypertensive patients with periodontitis. The subjects for the study will be selected from OPD in the Department of Periodontology, Manav Rachna Dental College, Faridabad. Selected subjects will be divided into 3 groups Group A, Group B and Group C based on hypertension and periodontal status. Group A consisting of Pre-Hypertensive  subjects with periodontitis, Group B comprising of Stage I Hypertensive periodontitis subjects  and Group C with Stage II Hypertensive periodontitis subjects .  All groups will undergo non-surgical periodontal therapy, recording of clinical parameters and saliva collection at baseline and at 1month. 3ml of unstimulated saliva will be collected by suction method and will be transferred to Eppendorf tubes. It will be stored at -80 degree centigrade till analysis. The Volatile organic compounds will be detected in saliva through the Gas chromatography- Mass spectrometry  analysis.

 
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