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CTRI Number  CTRI/2024/04/065231 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 02/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Diagnostic
Dentistry 
Study Design  Other 
Public Title of Study   To check blood values before teeth cleaning, after teeth cleaning and after gum surgery  
Scientific Title of Study   Evaluation of mean platelet values as inflammatory markers in patients with stage III periodontitis after scaling and root planing with flap surgery - A hematological 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  Joshua Carlos Misquita 
Designation  Post graduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  9545476404  
Fax    
Email  dr.joshuacm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Joshua Carlos Misquita  
Designation  Post graduate student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  9545476404  
Fax    
Email  dr.joshuacm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Walvekar 
Designation  Professor and Head of Department 
Affiliation  Coorg Institute of Dental Sciences 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu

Kodagu
KARNATAKA
571218
India 
Phone  9480085687  
Fax    
Email  amitakw@rediffmail.com  
 
Source of Monetary or Material Support  
Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu KARNATAKA 571218 India  
 
Primary Sponsor  
Name  Joshua Carlos Misquita 
Address  Coorg institute of dental sciences Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu 
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 Joshua Carlos Misquita  Coorg Institute of Dental Sciences  Department of periodontics and implantology Room 4 Kanjithnda Kushalappa campus Maggula Virajpet Karnataka Kodagu
Kodagu
KARNATAKA 		 9545476404

dr.joshuacm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD, COORG INSTITUTE 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 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Periodontal Flap surgery  Pockets which remain will then be treated with flap surgery one month after scaling and root planing. 
Intervention  Scaling and Root planing  Patients with stage â…¢ periodontitis will first be treated with scaling followed by root planing on the day of first visit  
 
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 â…¢ Periodontitis.
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.
3) Patients with any other systemic diseases.
4) Pregnant or lactating females.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Mean platelet volume of patients treated with scaling, root planing and flap surgery  One month, two months and three months after treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in mean platelet volume of patients treated with flap surgery  Two months & three months after treatment 
Decrease in other blood parameters such as neutrophil count after flap surgery  Three months after treatment 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 09/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
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 - NO
Brief Summary  

This study will be a split mouth single blinded randomized control trial and will be carried out on 25 participants within the age group of 35–65 years who will report to the Department of Periodontics and Implantology, Coorg institute of Dental Sciences Virajpet

At the first visit before therapy (baseline) a detailed case history will be noted down and a Complete blood count (CBC) test will be done to determine MPV, RBC, WBC and other blood values. After clinical, radiographic examinations, all patients will receive oral prophylaxis with supragingival scaling and subgingival debridement and after 1 month a CBC test will be done to determine MPV values. Patients will then be treated for the remaining pockets with flap surgery treatment. CBC test will be done 1 month after flap surgery to compare values in all 3 intervals.

Periodontal examinations will include plaque index (PI), bleeding index (BI), clinical attachment loss (CAL) and probing pocket depth (PD).

A total of 5 ml blood will be obtained by venipuncture from each participating subject, which will be injected into a vacuum tube with anticoagulant (ethylenediaminetetraacetic acid [EDTA). Blood samples in the vacuum tubes with EDTA will be used for complete blood count to determine the platelet and other blood values.

 
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