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CTRI Number  CTRI/2022/07/043936 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare efficacy of Turmeric, Friendly Bacteria, and Fluoride based mouth rinses in children  
Scientific Title of Study   A comparative evaluation of efficacy of curcumin, probiotic and fluoride containing mouth rinses on mutans streptococci and clinical inflammatory parameters of gingivitis in early mixed dentition period. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karuna 
Designation  PG student 
Affiliation  SGT University 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  7988736798  
Fax    
Email  dr.karunatewatia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Gupta 
Designation  Professor and Head of the Department 
Affiliation  SGT University 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9899039805  
Fax    
Email  anil.gupta@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Karuna 
Designation  PG student 
Affiliation  SGT University 
Address  Room no.6, Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences, SGT University Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  7988736798  
Fax    
Email  dr.karunatewatia@gmail.com  
 
Source of Monetary or Material Support  
SGT University, Budhera, Gurgaon , Haryana 122505  
 
Primary Sponsor  
Name  SGT University 
Address  Faculty of Dental Science,SGT University, Gurgaon-122505  
Type of Sponsor  Research institution and hospital 
 
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 
Karuna  SGT University, Budhera, Gurgaon 122505   Room no. 6 Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences
Gurgaon
HARYANA 		 7988736798

dr.karunatewatia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI GURUGOBIND SINGH TRICENTENARY UNIVERSITY, GURGAON  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  nil-  nil 
Intervention  randomised clinical trial  To assess antimicrobial efficacy of probiotic (VARUGUD LB), curcumin (0.1%), fluoride (0.05%) containing mouth rinses on mutans streptococci count by colony forming units and gingival health in 7-9 yr. old children. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Children of age 7-9 years.
2. Mixed dentition with erupted noncarious permanent central incisors and permanent 1st molars.
3. High caries risk Children with dmft scoring ≤3.
 
 
ExclusionCriteria 
Details  1. Children suffering from any systemic illness.
2. Patients with reduced manual dexterity (children with special health care needs).
3. Children who had taken any antibiotics in the last 14 days.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess antimicrobial efficacy of probiotic (VARUGUD LB), curcumin (0.1%), fluoride (0.05%) containing mouth rinses on mutans streptococci count by colony forming units and gingival health in 7-9 yr. old children.  microbiological evaluation at baseline sample and 1 month sample
gingival evaluation at baseline sample , 1 month , 3 months,6 months ,9 months.  
 
Secondary Outcome  
Outcome  TimePoints 
- To compare the efficacy of curcumin (0.1%), probiotic (VARIGUD LB), fluoride (0.05%) containing mouth rinses clinically using Nyvad criteria, gingival index, plaque index and microbiologically on microbiologically on mutans streptococci count by colony forming units at baseline sample and after 1 month follow up sample in 7-9year old children.   microbiological evaluation at baseline sample and 1 month sample
gingival evaluation at baseline sample , 1 month , 3 months, 6 months, 9months .  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2022 
Date of Study Completion (India) 14/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Use of mouth rinses along with daily brushing and flossing is useful for maintaining dental oral hygiene.  They help in reaching areas not easily accessed by a toothbrush and may further reduce the disease risk like arresting plaque accumulation, gingival inflammation, dental caries, and others risk used to reduce the microbial load in the mouth.
Streptococcus mutans has been associated with increased caries risk which is a gram-positive bacterium. Of all cariogenic microorganisms, S. mutans has many virulent factors such as producing acids from carbohydrates, tolerating an extreme acidic environment, and producing extracellular polysaccharides, which facilitate their adherence to other bacteria and tooth surfaces. These are acidogenic and form long-chain high molecular mass polymers which is an important virulent factor in the cariogenicity of S. Mutans.
Curcumin is a natural plant present in the curcuma longa. Previous studies have stated that the use of curcumin could decrease the biofilm activity of s. Mutans as they are inhibitors of quorum sensing in bacteria. It is an herbal and natural product that has no side effects. It is an antibacterial of S. Mutans.
Probiotics are dietary substances that compose bacteria or potentially useful fungi. They are being widely researched in bacteriotherapy. Bacteriotherapy is the method of harmonizing oral ecology and reducing the no. of cariogenic bacteria by an alternative approach. It has been found useful in reducing the amount of salivary S. Mutans and dental plaque, further reducing cariogenesis.
Fluoride is widely used in dentistry to control caries at either the community or individual levels. Scientific evidence exists on caries management through effective therapeutic interventions like fluoride.
Therefore, the aim of the present study is to compare the clinical efficacy of curcumin, probiotics. Once eligibility is confirmed according to the inclusion and exclusion criteria, the treatment procedure will be explained to the parent and after obtaining the consent from the parents the study will be conducted. 
 
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