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CTRI Number  CTRI/2024/07/069853 [Registered on: 03/07/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effect of Grape seed extract mouthwash, probiotic mouthwash and commonly prescribed mouthwash (Chlorhexidine) on salivary pH of children. 
Scientific Title of Study   Comparative Evaluation Of Mouth Rinsing With Probiotic Herbal And Chlorhexidine Mouthwash On Salivary pH Of Children- A Randomized Control 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 Rasika Talmale 
Designation  Post Graduate Student Department of Pedodontics and Preventive Dentistry  
Affiliation  Chhattisgarh Dental College And Research Institute, Rajnandgaon. 
Address  Room No. 4, first floor, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon.
Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon.
Rajnandgaon
CHHATTISGARH
491441
India 
Phone  7507366541  
Fax    
Email  talmalerasika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nagarathna PJ 
Designation  Head of the Department, Pedodontics and Preventive Dentistry. 
Affiliation  Chhattisgarh Dental College And Research Institute, Rajnandgaon. 
Address  Room no.4 Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon.

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9986889525  
Fax    
Email  drsiddu4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nagarathna PJ 
Designation  Professor and Head of Department 
Affiliation  Chhattisgarh Dental College and Research Institute, Rajnandgaon 
Address  Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon.

Rajnandgaon
CHHATTISGARH
491441
India 
Phone  9986889525  
Fax    
Email  drsiddu4@gmail.com  
 
Source of Monetary or Material Support  
Room No.4,Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College and Research Institute Sundra Rajnandgaon. 491441,India 
 
Primary Sponsor  
Name  Dr Rasika Talmale 
Address  Room no.4 Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College And Research Institute, Sundra, Rajnandgaon.491441, India 
Type of Sponsor  Other [[Self Funded]] 
 
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 Rasika Talmale  Chhattisgarh Dental College and Research Institute, Rajnandgaon.  Room no.4 Department of Pedodontics and Preventive Dentistry Rajnandgaon
Rajnandgaon
CHHATTISGARH 		 7507366541

talmalerasika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Chhattisgarh Dental College and Research Institute, Rajnandgaon  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine   0.12% CHLORHEXIDINE will be dispensed in the form of a mouthwash. 5 ml will be swished for 30 seconds, twice daily, for 1 week. 
Intervention  Grape seed extract mouthwash   1.563 gram of Grape seed extract powder mixed 100 ml distilled water and will be dispensed in the form of a mouthwash. 5 ml will be swished for 30 seconds twice daily, for 1 week. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Free from any systemic illness.
Children with informed consent. 
 
ExclusionCriteria 
Details  Children with periodontal diseases.
Children taken antibiotic within one month before the study.
Children with any congenital anomalies, physical or mental disabilities.
Children with any severe medical illness or allergy to any of the content of
mouthwash. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in Salivary pH Score. 
O(BASELINE), 1 WEEK  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Probiotic, Herbal and Chlorhexidine
mouthwash on salivary pH of children of 6 to 11 years. 		 1 week 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   16/08/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The maintenance of oral hygiene is one of the key elements of oral health. The oral cavity harbors bacteria and is exposed to environmental stimuli such as foods, chemicals, and temperature which remain in a balanced state during healthy state of mouth. However, imbalances in equilibrium of defense mechanisms and various stimuli lead to various oral diseases such as dental caries and periodontal diseases. Salivary pH has a direct effect in maintaining oral health. Acidic pH results in demineralization and gingival inflammation. Mouth rinsing results in clearance of debris and prevents accumulation of harmful bacteria, thereby promoting oral health. Saliva is a dynamic system which helps to maintain a balance of the carious process by various variables such as pH from a salivary fluid and buffer capacity. Salivary pH is a good indicator of demineralization which is the first step in the carious process. They are non-sterile aqueous solutions and used as an antibacterial agent which prevents the growth of bacteria in the mouth and teeth and for decreasing oral malodor. They are commonly used as topical solutions against plaque development, and also can be used frequently to prevent oral infections. Mouthwash supplements routine mechanical oral hygiene procedures in controlling supragingival plaque formation. Natural herbs when used in mouthwashes, have shown significant advantages over the chemical ones. Probiotics, another potential tool of anti-plaque activity, have been reported to have beneficial effects on oral health. Hence, the present study was designed with an aim to compare the effectiveness of herbal and probiotic mouthwashes with that of chlorhexidine (CHX) on salivary pH.  
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