FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080474 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device
Surgical/Anesthesia
Diagnostic
Dentistry
Other (Specify) [C reactive protein level in blood before and after treatment]  
Study Design  Single Arm Study 
Public Title of Study   To Compare The Effect Of Gum Disease Treatment by checking Blood Parameter 
Scientific Title of Study   Comparative Evaluation Of Plasma C Reactive Protein Levels Before And After Periodontal Therapy In Stage III Periodontitis Patients : A Clinico Biochemical 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 Anju C 
Designation  Postgraduate Student 
Affiliation  Coorg Institute Of Dental Science Virajpet 
Address  Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Maggula Virajpet Kodagu Karnataka

Kodagu
KARNATAKA
571218
India 
Phone  9447766337  
Fax    
Email  anjuc89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anju C 
Designation  Postgraduate Student 
Affiliation  Coorg Institute Of Dental Science Virajpet 
Address  Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Maggula Virajpet Kodagu Karnataka 571218 India

Kodagu
KARNATAKA
571218
India 
Phone  9447766337  
Fax    
Email  anjuc89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Radhika B 
Designation  Professor 
Affiliation  Coorg Institute Of Dental Science Virajpet 
Address  Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Maggula Virajpet Kodagu Karnataka 571218 India

Kodagu
KARNATAKA
571218
India 
Phone  9742096982  
Fax    
Email  radika_b24@yahoo.co.in  
 
Source of Monetary or Material Support  
Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Maggula Virajpet Kodagu Karnataka 
 
Primary Sponsor  
Name  Dr Anju C 
Address  Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Magula Virajpet Kodagu Karnataka 
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 
ANJU C  Coorg Institute Of Dental Science  Coorg Institute Of Dental Science Department Of Periodontics And Implantology Room 4 KK Campus Maggula Virajpet Kodagu Karnataka
Kodagu
KARNATAKA 		 9447766337

anjuc89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Review Board, Coorg Institute Of Dental Science  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  periodontal therapy includes scaling and root planing and flap surgery  Compare and evaluate the impact of scaling and root planing (SRP) and flap surgery on the plasma CRP levels in Stage III periodontitis patients at baseline,1 month after scaling and root planing and 3 months after flap surgery 
Comparator Agent  without periodontal therapy  comparing C reactive protein levels with and without periodontal therapy 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients of age between 35 and 65 years
2.Patients with stage III Periodontitis with Probing depth ≥6mm, vertical bone loss ≥3mm, furcation involvement Class Ⅱ and Ⅲ, moderate ridge defects.
3.Patients without any history of previous periodontal therapy
 
 
ExclusionCriteria 
Details  1)Current or previous smokers and alcoholics.
2)History of periodontal therapy or antimicrobial therapy within 6 months, or history of orthodontic therapy.
3)Patients with any other systemic diseases.
4)Pregnant or lactating females
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
periodontitis is associated with elevation in plasma C reactive protein levels and that periodontal therapy is able to bring down the levels of c reactive protein.  All clinical parameters and plasma c reactive protein will be measured at baseline,1 month after scaling and root planing and 3 months after flap surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
comparison and evaluation of the impact of scaling and root planing (SRP) and flap surgery on the plasma CRP levels in Stage III periodontitis patients.  All clinical parameters and plasma c reactive protein will be measured at baseline,1 month after scaling and root planing and 3 months after flap surgery. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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
Modification(s)  		 N/A 
Date of First Enrollment (India)   05/05/2025 
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="0"
Months="3"
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   This study is a clinico biochemical study where 20 patients of both gender with stage 3 periodontitis, satisfying all the inclusion criteria will be enrolled for the study. This study evaluates plasma c reactive levels in stage 3 periodontitis patients before treatment, after scaling and root planing, and after flap surgery. Initial assessments will include a detailed case history and clinical parameters, with blood samples taken for CRP detection. Patients will receive scaling and root planing and return after 1 month for reevaluation. Those with persistent pockets will undergo flap surgery, with follow up assessments 3 months later. CRP levels will be compared at these three intervals. 
Close