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CTRI Number  CTRI/2024/09/074027 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 15/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the effect of herbal mouthwash (Oralife)and Chlorhexidine mouthwash (Rexidine SRS) in patients with gum disease. 
Scientific Title of Study   Comparative Evaluation of Efficacy of Herbal Mouthwash (Oralife) with Chlorhexidine Mouthwash (Rexidine SRS) in Generalized Chronic Periodontitis Patients- A Randomized Clinical Trial 
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 Aishwary Patil 
Designation  3 year postgraduate 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, Room No 202,Nair Hospital Dental College, opposite maratha mandir, mumbai central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  8446022798  
Fax    
Email  aishwaryupatil@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praneeta Kamble 
Designation  Assistant Professor 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, Room No 202,Nair Hospital Dental College, opposite maratha mandir, mumbai central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praneeta Kamble 
Designation  Assistant Professor 
Affiliation  Nair Hospital Dental College 
Address  Department of Periodontics, Room No 202,Nair Hospital Dental College, opposite maratha mandir, mumbai central, Mumbai.

Mumbai
MAHARASHTRA
400008
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental College, Mumbai 
 
Primary Sponsor  
Name  Dr Aishwary Patil 
Address  Nair Hospital Dental College, opposite maratha mandir, mumbai central, Mumbai Pincode-440008,Maharstra 
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 Aishwary Patil  Nair Hospital Dental College  Department of Periodontics, Room No 202,Nair Hospital Dental College, opposite maratha mandir, mumbai central, Mumbai
Mumbai
MAHARASHTRA 		 8446022798

aishwaryupatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethics committee Nair Hospital Dental College  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  Chlorhexidine mouthwash (Rexidine SRS)   Rexidine SRS mouthrinses twice a day for 30 sec for 30 days. 
Intervention  Herbal mouthwash (OralifeTM)  Oralife TM mouth rinses twice a day for 30 sec for 30 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients in the age group between 20-60 yrs.
2.Patients diagnosed with Chronic Periodontitis.
3.Patients who are non smokers or do not consume tobacco in any other form.
4.Patients with good systemic health.
 
 
ExclusionCriteria 
Details  1.Individuals suffering from any systemic diseases.
2. Individuals wearing fixed or removable orthodontic appliances or
prosthesis
3. Pregnant and lactating females
4. Individuals taking medications since prolonged duration
5. Smokers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.) (Silness and Loe, 1964)
2. Gingival Index (G.I.) (Loe and Silness, 1963)
3. Probing Pocket Depth (PPD)
 		 Baseline, 1 month Post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical attachment level  Baseline, 1 month post treatment 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/11/2024 
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="2"
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   Aim-To clinically compare and evaluate the efficacy of herbal mouthwash (OralifeTM) with Chlorhexidine Mouthwash(Rexidine® SRS).
Materials and Methods- 

This study is an Interventional Prospective Clinical Trial. It is a double-blinded, single-centre, Institution-based study. The patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, and treated as follow.

Group A: Scaling and chlorhexidine (Rexidine® SRS 0.2%) mouthwash

Group B: Scaling and herbal (OralifeTM) mouthwash

The following clinical parameters will be recorded at baseline (post scaling), 1 month post-scaling. 1. Plaque Index (P.I.) (Silness and Loe, 1964) 2. Gingival Index (G.I.) (Loe and Silness, 1963) 3. Probing Pocket Depth (PPD) 4. Clinical Attachment Loss(CAL)

 
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