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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  
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
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
 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aditi.chopra@manipal.edu].

  6. 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.

  7. 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.

 
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