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CTRI Number  CTRI/2024/04/065213 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of germs causing Gum disease. 
Scientific Title of Study   Assessment of Correlation of Red Complex Bacteria in Saliva and Gingival Crevicular Fluid(GCF) using Multiplex Real Time – Polymerase Chain Reaction(RT-PCR) In Subjects with 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  Sahin Sahalam Mollick Mollick 
Designation  Post Graduate Student 
Affiliation  Dayananda Sagar College of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Kumaraswamy layout, 1st stage, Bangalore.

Bangalore
KARNATAKA
560078
India 
Phone  9975544207  
Fax    
Email  sahim269@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savita A M 
Designation  Professor and Head of the Department  
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Kumaraswamy layout, 1st stage, Bangalore.

Bangalore
KARNATAKA
560078
India 
Phone  9845433660  
Fax    
Email  savitaam@dscds.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Savita A M 
Designation  Professor and Head of the Department  
Affiliation  Dayananda Sagar College Of Dental Sciences 
Address  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Kumaraswamy layout, 1st stage, Bangalore.

Bangalore
KARNATAKA
560078
India 
Phone  9845433660  
Fax    
Email  savitaam@dscds.edu.in  
 
Source of Monetary or Material Support  
Infrastructural support from Dayananda Sagar College of Dental Sciences, 1st stage Kumaraswamy Layout, Bangalore- 560078. 
 
Primary Sponsor  
Name  Dr Sahin Sahalam Mollick Mollick  
Address  Dayananda Sagar College of Dental Sciences, Kumarswammy layout,1st stage ,Bangalore. 
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 Savita A M  Dayanand Sagar College of Dental Sciences, bangalore  Room 402, Department of Periodontics, Dayananda Sagar College of Dental Sciences, Kumaraswamy layout, 1st stage, Bangalore.
Bangalore
KARNATAKA 		 984533660

savitaam@dscds.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Dayananda Sagar College of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age group 20-60 yrs

2.Clinically diagnosed periodontitis (based on the 2017 world workshop classification of periodontal disease).

3..Presence of at least two teeth with a probing depth of ≥5mm and clinical attachment loss of ≥3mm in each quadrant.(stage 2 ,stage 3 and stage 4 periodontitis, based on the 2017 world workshop classification of periodontal disease).
 
 
ExclusionCriteria 
Details  1.Subjects who have undergone Periodontal treatment since past 6 months.
2. Use of antibiotics & anti-inflammatory drugs since past 3 months.
3. Pregnant and lactating women.
4. Smokers and tobacco chewer.
5. Substances and any Drug abuse.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.To assess and find a correlation of the levels of red complex bacteria (Porphyromonas gingivalis,
Tannerella forsythia &Treponema denticola) in the saliva and GCF samples in subjects with
periodontitis by multiplex RT-PCR technique.  		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
2.To compare the level of red complex bacteria (Porphyromonas gingivalis, Tannerella forsythia, &Treponema denticola) in the saliva and GCF in patients with periodontitis by multiplex RT-PCR technique.  Baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/04/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [sahim269@gmail.com].

  6. For how long will this data be available start date provided 29-01-2026 and end date provided 29-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary    Periodontitis is a chronic inflammation associated with dysbiotic subgingival biofilms , resulting in progressive and irreversible destruction of the tooth supporting tissues.Although it is not clear whether dysbiotic biofilms initiate the disease or is a consequence of the disease, it is well established that at diseased status the subgingival microbiota is enriched with gram-negative, proteolytic bacteria, while in healthy situation, the microbiota is mainly composed of gram-positive bacteria.Among microbial complexes, the first complex that has been related to disease is the orange complex consisting of anaerobic gram-negative species (Prevotella intermedia, Prevotella nigrescens, Prevotella micros, and Fusobacterium nucleatum) which on disease progression shifts toward red-complex bacteria consisting of Tannerella forsythia, Treponema denticola, and Porphyromonas gingivalis.The red complex bacteria play a critical role in the pathogenesis of periodontitis. These bacteria are found together in periodontal pocket, implicating that they work in synergistic manner leading to destruction of periodontal tissue. The prevalence of periodontitis in India is 51%, and studies related to diagnosis of different forms of Periopathogens are few in Indian published literature, hence its also necessary to further establish data regarding the same.Hence an attempt is being made to assess and correlate in both saliva and GCF the red complex bacteria Porphyromonas Gingivalis (Pg), Tannerella Forsythia (Tf) & Treponema Denticola (Td) using Multiplex RT-PCR using saliva and GCF samples in periodontitis patients.   
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