| 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
|
|
|
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
|
|
|
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. |