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CTRI Number  CTRI/2025/01/079176 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation and comparation of the effect of the 0.2 percent Chlorhexidine and Herbal mouthwash on Salivary Uric acid level and Oral health among Dental patients.  
Scientific Title of Study   Effect of the 0.2 percent Chlorhexidine and Herbal mouthwash on Salivary Uric acid and Oral health – A Randomized Controlled 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 P G Naveen Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9482562631  
Fax    
Email  pgnaveenkumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR P G Naveen Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9482562631  
Fax    
Email  pgnaveenkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR P G Naveen Kumar 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9482562631  
Fax    
Email  pgnaveenkumar@gmail.com  
 
Source of Monetary or Material Support  
Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh 221005, India. 
 
Primary Sponsor  
Name  DR P G Naveen Kumar 
Address  Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh 221005, India. 
Type of Sponsor  Other [Self sponsored] 
 
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 P G Naveen Kumar  Banaras Hindu University.  Room no 8, Fourth floor, Public Health Dentistry, Faculty of Dental Sciences, IMS, Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH 		 9482562631

pgnaveenkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Banaras Hindu University - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health individuals ranging from 20 to 40 years with mild to moderate gingivitis without any systemic diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.2 percent Chlorhexidine mouthwash  ICPA Health product - Hexidine mouthwash consists of Chlorhexidine gluconate solution I.P. diluted to 0.2 percent weight by volume. The participants will be advised to use this mouthwash for 10 days. 
Intervention  Herbal mouthwash   The herbal mouthwash named “Oralife” is an alcohol free mouthwash formulated with botanical extracts of Pomegranate Dadima (Punica granatum), Grapefruit seed extract Jambir (Citrus paradisi) and Thymol Yavanisatva (Thymus vulgaris). The participants will be advised to use this herbal mouthwash for 10 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects ranging from 20 to 40 years with mild to moderate gingivitis according to Loe and Sillness gingival index without any systemic diseases will be admitted in the study.  
 
ExclusionCriteria 
Details  Subjects with history of use of any mouthwash, antibiotics, probiotics supplement in past three months; medically compromised individuals; subjects with fixed or removable orthodontic appliances or removable prosthesis or severe intraoral infections will be excluded. 
 
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 
Salivary Uric acid level.  Outcome will be assessed at baseline and on the eleventh
day after the use of mouthwash for 10 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index & gingival index.   Outcome will be assessed at baseline & on the eleventh
day after the use of mouthwash for 10 days. 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 4 
Date of First Enrollment (India)   01/02/2025 
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="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 double blinded clinical trial will be performed for a period of ten days on 28 randomly selected mild to moderate gingivitis patients divided into two groups (n=14). Group A will receive herbal mouthwash and Group B will receive 0.2% Chlorhexidine mouthwash. Unstimulated saliva will be collected at baseline and ten days after the use of the mouthwash for the estimation of salivary uric acid level. Plaque and gingival condition will be assessed by using Silness and Loe plaque index, Loe and Silness gingival index respectively. 

 
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