| CTRI Number |
CTRI/2024/07/069948 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To explore the prevalence, genetic and microbial profile of patients with aggressive nature of gum diseases |
|
Scientific Title of Study
|
In-depth Exploration of the Prevalence, Genetic, and Microbiome Profile of Indian Population with Varying Severity of Periodontitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No. 3, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, India Manipal Academy of Higher Education Udupi KARNATAKA 576104 India |
| Phone |
08292922173 |
| Fax |
|
| Email |
draditichopra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No. 3, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, India Manipal Academy of Higher Education Udupi KARNATAKA 576104 India |
| Phone |
08292922173 |
| Fax |
|
| Email |
draditichopra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Sciences, Manipal |
| Address |
Room No. 3, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, India Manipal Academy of Higher Education Udupi KARNATAKA 576104 India |
| Phone |
08292922173 |
| Fax |
|
| Email |
draditichopra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Manipal Academy of Higher Education, Madhav Nagar Udupi District, Karnataka, India; pin:576104 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Chopra |
| Address |
Manipal College of Dental Sciences, Manipal.
Manipal Academy of Higher Education, Udupi District, Karnataka, India.pin 576104 |
| 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 Aditi Chopra |
Manipal College of Dental Sciences |
Department of Periodontology, Manipal College of Dental Sciences, Manipal
Manipal Academy of Higher Education, Udupi District, Karnataka Udupi KARNATAKA |
918202922173
aditi.chopra@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Karturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All participants between 10-80 years of age (both males and females) will be screened for the presence or absence of PD according to the 2017 classification of periodontal diseases (Caton et al., 2018, Papapanou et al., 2018). The study will include all clinically healthy patients with gingivitis and those with periodontitis (all stages and grades). Patients from diverse age groups will be analyzed to determine the prevalence of periodontitis in those below 25 years of age (early onset periodontitis) and to evaluate the variation in the genetic and microbial profile of such patients and those above 25 years. |
|
| ExclusionCriteria |
| Details |
All physically and mentally challenged individuals will be excluded.
All participants with any systemic condition/ immunocompromising condition such as HIV, autoimmune diseases, or active infections such as tuberculosis, hepatitis, etc. will be excluded.
Pregnant and lactating mothers will be excluded
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Overall prevalence and changing trends of varying severity of periodontitis in the Udupi district according to the 2017 classification of PD from 2000-2024
2. Prevalence of the rapidly progressing form of periodontitis (PD) (Stage III/IV grade C) among individuals below 25 years of age.
3. Genetic variants/mutation in individuals with healthy and varying severity of PD (including Stage III/IV grade C). |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Microbial profile of patients with gingival health, gingivitis, and PD/ perimplantitis (All stages and grades).
2. Levels of E. gingivalis in patients with gingival health, gingivitis, PD (All stages and grades), and those with periimplantitis.
3. Periodontal clinical parameters (presence or absence of interdental papillae; full-mouth bleeding on probing (presence or absence), full-mouth probing pocket depth (in mm) and clinical attachment loss (CAL); the presence of any teeth with mobility/ furcation/ recession; degree of alveolar bone loss on dental radiographs (in mm); DMFT, BMI, other demographic variables as described previously |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="5000" Sample Size from India="5000"
Final Enrollment numbers achieved (Total)= "325"
Final Enrollment numbers achieved (India)="325" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2024 |
| Date of Study Completion (India) |
08/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aditi.chopra@manipal.edu].
- For how long will this data be available start date provided 26-06-2024 and end date provided 25-07-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Periodontal disease is a prevalent and complex immunoinflammatory disease affecting the oral cavity and has proven to be a risk factor for many systemic diseases. It is one of the major global health challenges and is considered the 11th most common disease worldwide (Tonetti et al., 2017). In India, approximately 80–90% of Indians suffer from some form of periodontal disease (Chandra et al., 2016; Shaju et al., 2011). Periodontal disease starts as inflammation of the gums (gingivitis), which later progresses to the underlying bone and soft tissues, resulting in periodontitis (PD). According to the current classification of periodontal diseases and conditions, (Caton et al., 2018), PD is classified according to its severity (by staging) and rate of progression (by grading). A severe form of PD manifests as advanced generalized bone loss. early tooth loss, pain, mobility of teeth, pus discharge, swelling, and severe gingival inflammation. This severe and rapidly progressing form of PD significantly impacts about 11.2% of the global population (Marcenes et al., 2013; Tonetti et al., 2017). Although microbial plaque remains the primary etiology of PD, a severe form of PD. characterized by phenotypes (Stages III and IV) with a rapid rate of progression (Grade C) is known to have a genetic etiology. This form of PD, which is typically early-onset (EO-PD), starts in children and adolescents and progresses at a rapid rate with early loss of teeth and edentulism. In such genetically predisposed individuals, PD develops independently of common extrinsic risk factors such as smoking, systemic diseases, and the nature of the microbiome. This indicates that EO-PD is largely caused by intrinsic genetic factors with strong penetrance. Studies have shown that for this form of PD, the heritability for bone loss is estimated to be 0.4–0.5, and the heritability increases with younger individuals with EO-PD (Nibali et al., 2019). Notably, the genetic variants found to be causative for the disease in the young can also be used to identify susceptibility factors leading to massive bone destruction and tooth loss in adult PD (Fuchsberger et al., 2016; Genovese et al., 2016). A previous study identified deleterious putative causative mutations in the affected siblings, indicating important disease-relevant genes. Notably, some of these high-impact rare variants were also located within risk genes associated with common forms of PD (Richter et al., 2022). Based on this previous work, the proposed study aims to determine the prevalence of varying severity of PD in the Indian population, according to the 2017 classification of periodontal disease. The study also aims to identify rare susceptibility variants of rapidly progressive severe (Stage III/IV grade C) PD in Indian descent (EO-PD) The study also aims to correlate the genetic variants and periodontal conditions that run in their families with siblings. The study will help to understand the genetic factors responsible for severe bone loss and rapidly spreading inflammation in such individuals. In addition, it is of great interest to investigate the microbial profile in the rapidly progressive nature of PD. Currently, our understanding of PD is limited to the role of specific pathogenic oral bacteria, but a comprehensive analysis of the microbial profile could provide insight into the dynamic and aggressive nature of one of the most prevalent diseases affecting mankind today. |