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CTRI Number  CTRI/2025/06/089832 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Study of Herbal Mouthwash as Dispersible Tablets. 
Scientific Title of Study   A Comparative Study of Herbal Mouthwash as Dispersible Tablets: Seabuckthorn and Jamun Seed Extracts vs Chlorhexidine for Assessment of Plaque Index of Children in age group of 7-14 years- A Double-Blinded Randomized Clinical Trail. 
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 Chaya Chhabra 
Designation  Professor and Head of the Department  
Affiliation  NIMS Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, NIMS Dental College and Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN
303121
India 
Phone  9929535666  
Fax    
Email  chaya.chhabra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrushti Raju Thakare 
Designation  Postgraguate 
Affiliation  NIMS Dental College and Hospital 
Address  NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
room no.7, NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN
303121
India 
Phone  9607668889  
Fax    
Email  shrushtithakare31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chaya Chhabra 
Designation  Professor and Head 
Affiliation  NIMS Dental College and Hospital 
Address  NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN
303121
India 
Phone  9929535666  
Fax    
Email  chaya.chhabra@nimsuniversity.org  
 
Source of Monetary or Material Support  
NIMS Dental College and Hospital, NIMS University, Jaipur, Rajasthan, India - 303121. 
 
Primary Sponsor  
Name  Dr Shrushti Thakare 
Address  Magnolia Girls Hostel 212, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan, India- 303121 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
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 Shrushti Raju Thakare  NIMS Dental College  NIMS Dental College And Hospital, NIMS University, B S Tomar City, Shobha Nagar, Jaipur-Delhi Highway, Jaipur, Rajasthan- 303121
Jaipur
RAJASTHAN 		 09607668888

shrushtithakare31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children aged 7–14 yrs without systemic issues, able to maintain oral hygiene, follow protocol, with cooperative, accepting parents or caregivers. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged between 7-14 years
Participants in good general health without systemic diseases or conditions affecting oral health.
Children who are able to comply with oral hygiene instructions and follow the study protocol.
Parents/caregivers acceptance and cooperation 
 
ExclusionCriteria 
Details  Presence of any oral pathology, such as gingival overgrowth or abscesses requiring urgent treatment.
Children with orthodontic appliances (e.g., braces or space maintainers) that could interfere with plaque assessment.
Systemic health conditions or medications that could influence oral hygiene or microbial flora (e.g., diabetes, immunosuppression).
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.  The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Gingival Health:
Monitoring changes in gingival index or signs of gingival inflammation to assess any additional periodontal benefit.

Acceptability & Compliance:
Evaluating the taste acceptability, ease of use, & adherence to using dispersible tablet formulations in children.

Adverse Effects:
Documenting any side effects such as tooth staining, altered taste sensation, or mucosal irritation associated with either the herbal or Chlorhexidine mouthwash. 		 8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   01/11/2025 
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="1"
Months="0"
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 randomized, double-blinded clinical trial aims to compare the efficacy of herbal mouthwash formulated as dispersible tablets containing Seabuckthorn and Jamun seed extracts with that of standard Chlorhexidine mouthwash tablets. The target population includes children aged 7 to 14 years. The primary objective is to assess and compare the reduction in plaque index among the groups. Secondary objectives include evaluating improvements in gingival health, patient acceptability of the herbal formulation, and recording any adverse effects. By exploring natural alternatives to Chlorhexidine, the study seeks to provide a safer, effective, and child-friendly option for maintaining oral hygiene and controlling dental plaque.

 
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