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CTRI Number  CTRI/2022/06/043056 [Registered on: 07/06/2022] Trial Registered Prospectively
Last Modified On: 03/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   STUDY TO COMPARE THE CLINICAL OUTCOME OF OZONE GEL VERSUS CHLORHEXIDINE GEL IN PERIODONTITIS PATIENTS.  
Scientific Title of Study   Efficacy of ozone gel with chlorhexidine gel delivered locally in periodontal pockets in chronic periodontitis patients. A randomized controlled double blind clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHIVANI SACHDEVA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Rural Dental College; Pravara institute of medical sciences 
Address  Department of Periodontolgy Rural Dental College Pravara institute of medical sciences Loni 413736
Pravara institute of medical sciences,DU, Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09730548805  
Fax    
Email  dr.shivani19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHIVANI SACHDEVA 
Designation  Associate Professor 
Affiliation  RDC Pravara institute of medical sciences 
Address  Department of Periodontolgy Rural Dental College Pravara institute of medical sciences Loni 413736
Pravara institute of medical sciences, DU, Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09730548805  
Fax    
Email  dr.shivani19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Sachdeva 
Designation  Associate Professor 
Affiliation  RDC Pravara institute of medical sciences 
Address  Dept of Periodontolgy Rural Dental College Pravara institute of medical sciences Loni 413736
Pravara institute of medical sciences, DU, Loni
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09730548805  
Fax    
Email  dr.shivani19@gmail.com  
 
Source of Monetary or Material Support  
Rural Dental College, Pravara institute of medical sciences, Loni, all cases included from the institute.  
 
Primary Sponsor  
Name  SHIVANI SACHDEVA 
Address  Department of Periodontology, Rural Dental College, PIMS Loni – 413736, Tehsil – Rahata, Ahmednagar, Maharashtra Associate professor 9730544805 dr.shivani19@gmail.com  
Type of Sponsor  Other [INDIVIDUAL] 
 
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 SHIVANI SACHDEVA  Rural Dental College, Pravara Institute of Medical Sciences  Department of Periodontolgy Rural Dental College Pravara institute of medical sciences Loni 413736
Ahmadnagar
MAHARASHTRA 		 9730548805

dr.shivani19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Pravara institute of medical sciences (IEC-PIMS DU). Loni 413736  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease, (2) ICD-10 Condition: B999||Unspecified infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Systemically healthy subjects with probing pocket depth of 3-7mm
2.Patients exhibited 1-2 mm of clinical attachment loss
3.Horizontal bone loss with no furcation involvement
4.Age range of 20-50 years old of any gender.
5.Patients willing to give written and informed consent before any study specific procedure.
6.Hemodynamically stable patients
 
 
ExclusionCriteria 
Details  1.Patients requiring periodontal flap surgery
2.Recurrent history of periodontal infections and wearing orthodontic brackets.
3.Use of antibiotics in the past 3–4 weeks
4.History of use of gel application or use of mouthwash within last month
5.Patient with acute necrotizing ulcerative gingivitis, acute herpetic gingivostomatitis, allergic gingivitis, gingivitis associated with skin diseases, gingivitis associated with endocrine-metabolic disturbances, gingivitis associated with hematologic-immunologic disturbances, gingival enlargement associated with medications, gingival tumors.
5.Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS
6.Subjects who having psychiatry/physical morbidity and cannot perform proper manual brushing
7.Individuals with known systemic disease
8.Smokers
9.Pregnant, lactating women, allergic to ozone gel and the patients with history of any previous periodontal or antibiotic therapy.
Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary
1. To assess and compare the gingival index and plaque index in Group A and Group B at baseline and 3 months.
2. To assess and compare pocket depth reduction and clinical attachment levels in ozone gel group and chlorhexidine gel group at 3 months.
3. To assess and compare the colony forming units (CFU) of E.coli in plaque samples at baseline and 3 months GROUP A and GROUP B.
 
3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1. to compare the primary outcome in different groups for age and gender  3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   15/06/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/05/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   ALREADY PUBLICATIONS ARE THERE RELATED TO OUR STUDY. AND THE RESULTS WERE POSITIVE FOR OUTCOME 
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 (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 15-07-2021 and end date provided 05-01-2023?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, double blind, single centre, parallel group, Phase III clinical study to evaluate treatment outcome for two groups; first is the OZONE GEL (experimental /test drug) and second is the CHLOREXIDINE GROUP (gold standard). The aim of the study is to evaluate the which has better treatment outcome in reduction of periodontal pocket depth and decreasing colony forming units in chronic periodontitis patients. The primary variables will be age, gender, probing pocket depth, gain in the attachment levels, plaque index, modified gingival index, colony forming units, recurrence and healing.  
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