| CTRI Number |
CTRI/2025/03/081853 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
An association between gum disease and metabolic syndrome |
|
Scientific Title of Study
|
An association between periodontal disease and metabolic syndrome a case control 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 Nisha Verlianey |
| Designation |
Assistant Professor |
| Affiliation |
government dental college and hospital Jamnagar |
| Address |
Department of
Periodontology, Room
No.6, Government Dental
College and Hospital,
Navagam ghed,Jamnagar-361008,India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825500637 |
| Fax |
|
| Email |
nisha.verlianey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Verlianey |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of
Periodontology, Room
No.6, Government Dental
College and Hospital,
Navagam ghed,Jamnagar-361008,India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825500637 |
| Fax |
|
| Email |
nisha.verlianey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Verlianey |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of
Periodontology, Room
No.6, Government Dental
College and Hospital,
Navagam.
Jamnagar
GUJARAT
361008
India |
| Phone |
9825500637 |
| Fax |
|
| Email |
nisha.verlianey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar-361008,India |
|
|
Primary Sponsor
|
| Name |
Dr Nisha Verlianey |
| Address |
Department of
Periodontology, Room
No.6, Government Dental
College and Hospital,
Navagam ghed,Jamnagar-361008,India
|
| Type of Sponsor |
Other [SELF] |
|
|
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 Nisha Verlianey |
Government Dental College and Hospital, Jamnagar |
Department of
Periodontology, Room
No.6
Jamnagar
GUJARAT |
9825500637
nisha.verlianey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M.P. Shah Medical College and Guru Gobindsingh Hospital, Jamnagar |
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: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
metabolic syndrome |
The National Cholesterol Education Program Adult Treatment Panel III defines it as an individual with at least three of the following risk factors ;(a) elevated glucose levels ,(b)low plasma levels of high density lipoprotein cholesterol, (c) increased values for plasma triglycerides,(d)elevated blood pressure, (e)increased abdominal circumference. increase incidence of periodontal infection in metabolic syndrome patient is compared with better periodontal health in systemically healthy patient . there is proposed increased inflammatory burden on peridontal tissues in patients having metabolic syndrome
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients between age 20- 65 years
b) Patients with at least 20 teeth present in the oral cavity
|
|
| ExclusionCriteria |
| Details |
a) Patients with history of periodontal treatment in past 6 months.
b) Pregnant and Lactating females.
c) Patients with less than 20 teeth present in the oral cavity.
CASES will be defined as subjects with metabolic disorder having periodontal infection whereas CONTROLS will be subjects with no systemic condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient with metabolic syndrome have altered inflammatory and infectious biomarkers which leads to an increase in the incidence of periodontal infection adding to the systemic disease of the body |
at baseline the assessment of the clinical significance between patients having periodontal infection and the dysmetabolic systemic status of an individual was compared with systemically healthy patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periodontal infection and metaolic syndrome association can be highlighted to the medical professionals and general population.Periodontal therapy can reduce the inflammatory burden on the body and aid in management of systemic diseases. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| 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="3"
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
|
Periodontal
Infection is a chronic inflammatory disease associated with dysbiotic plaque
biofilms and characterized by progressive destruction of the tooth supporting structures.
It has a multifactorial etiology with microbial ,environmental and host
associated etiologic factors and leads to several elevated inflammatory
mediators like C-Reactive Protein and interleukin -6 into the systemic
circulation.
Metabolic Syndrome
is a cluster of conditions that occur concomitantly and together they increase
the risk of cardiovascular diseases and double the risk of type 2 diabetes. The National Cholesterol Education
Program Adult Treatment Panel III defines it as an individual with at least
three of the following risk factors ;(a) elevated glucose levels ,(b)low plasma
levels of high density lipoprotein cholesterol, (c) increased values for plasma
triglycerides,(d)elevated blood pressure, (e)increased abdominal circumference.
There has been a
common factor of systemic inflammation and insulin resistance in both these
diseases and hence they can potentially influence one another. Several studies have suggested that periodontitis
can affect systemic conditions.
And successful periodontal treatment can decrease circulating levels of
inflammatory mediators. Aim :
The aim of this study is
to evaluate the association between periodontal infection and metabolic
syndrome.
Objectives
1 To establish the
clinical significance of the association between patients having periodontal
infection with the dysmetabolic systemic status.
2 To investigate the
association of severity of inflammatory and metabolic markers with periodontal disease.
The data will
be collected from the 500 patients visiting the OPD of the Department of
Periodontology, Government Dental College and Hospital, Jamnagar, Gujarat. After
informing the patient about the study and completing the formalities in the
consent form, the patients will be enrolled and data collection in the proforma
will be done. The patient data sheet of the subjects will be
filled with demographic data, chief complain, habit details and a comprehensive
periodontal examination by a single examiner including Probing pocket depth (PPD),
Clinical Attachment Levels(CAL) and Oral hygiene
Index-Simplified (OHI-S).
The current
metabolic status will be evaluated by Complete Blood Count, Lipid Profile, Hba1c,
for average blood sugar status and C-Reactive protein to assess the
inflammatory status. The non-invasive data to be recorded will be the abdominal
girth, height and weight to calculate the BMI and the waist to hip ratio.
|