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CTRI Number  CTRI/2013/01/003291 [Registered on: 11/01/2013] Trial Registered Retrospectively
Last Modified On: 04/01/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two herbal mouthwashes green tea and guava in 12-15 years old school children with gum disease in Belgaum city. 
Scientific Title of Study   Comparison of effectiveness of two herbal mouthrinses (Green tea and Guava)on plaque and gingival scores among 12-15 years old school children in Belgaum city-A Randomized Controlled Field Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1137-9534  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sweta J Toshniwal 
Designation  MDS,Postgraduatestudent 
Affiliation  KLE,VK Institute of Dental Sciences 
Address  Dept of Public Health Dentistry, KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.
KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.
Belgaum
KARNATAKA
590010
India 
Phone  08431887463  
Fax    
Email  sweta.toshniwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamata Hebbal 
Designation  MDS,Reader 
Affiliation  KLE,VK Institute of Dental Sciences 
Address  Dept of Public Health Dentistry, KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.
KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.
Belgaum
KARNATAKA
590010
India 
Phone    
Fax    
Email  drmamatahebbal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sweta J Toshniwal 
Designation  MDS,Postgraduatestudent 
Affiliation  KLE,VK Institute of Dental Sciences 
Address  Dept of Public Health Dentistry, KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.
KLE,VK Institute of Dental Sciences,Nehru nagar,Belgaum, Karnataka.

KARNATAKA
590010
India 
Phone  08431887463  
Fax    
Email  sweta.toshniwal@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Dr Sweta J Toshniwal 
Address  Dept oF public Health Dentistry, KLE, VK Institute of Dental sciences,Nehru nagar,Belgaum,Karnataka. 
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 Sweta J Toshniwal  KLE ,VK Institute of Dental Sciences  Department no -2 ,public Health Dentistry .KLE ,VK Institute of Dental Sciences, Nehru Nagar ,Belgaum .
Belgaum
KARNATAKA 
08431887463

sweta.toshniwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Etthics and Research Committee KLE Universitys VK Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gum Diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control -Chlorhexidine Mouthwash  Chlorhexidine Mouthwash- 5ml twice daily for 30 seconds for 30 days 
Intervention  Green Tea, Guava Mouthwash.   Green tea , Guava - mouthwash -5ml wice daily for 30 seconds for 21 days.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Free from systemic diseases.
Subjects whose gingival scores are moderate and plaque scores are fair.
Subjects having DMFT scores between 3 and 6.
Should not have used mouthwashes for the last 1 month.
ï‚— All the index teeth should be erupted.
ï‚— Subjects whose parents give informed consent.
ï‚— Free from systemic diseases.
ï‚— Subjects whose gingival scores are moderate and plaque scores are fair.
ï‚— Subjects having DMFT scores between 3 and 6.
ï‚— Should not have used mouthwashes for the last 1 month.
ï‚— All the index teeth should be erupted.
ï‚— Subjects whose parents give informed consent.
 
 
ExclusionCriteria 
Details  Suffering from diseases which might affect the salivary flow.
History of antibiotic therapy in the previous one month till the start of the study
Subjects having retained deciduous teeth.
Subjects using any mouthwashes.
ï‚— Subjects suffering from any physical or mental handicap
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Scores and Gingival Scores.  21 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival Scores.  21 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/08/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NO 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Present study was a  randomized controlled field trial conducted to compare the effectiveness of green tea, guava and Chlorhexidine mouthwashes on plaque scores , gingival scores  among 12-15 years old school children in Belgaum city.  Ethical clearance was obtained. Two stage random sampling was done. One  school was randomly selected from the  schools of Belgaum city. Permissions from the headmaster and Consent from the parents was obtained. All the children aged between 12-15 years were screened for inclusion and exclusion criteria. From the eligible candidates, a sample of 90 was randomly selected. These 90 participants were randomized into 3 groups- Those receiving green tea  mouthwash– Group I (n= 30) ,Those receiving guava  mouthwash – Group II (n= 30)  and those receiving Chlorhexidine mouthwash- Group III (n= 30). Baseline data for plaque index, gingival index  was recorded for all the children selected.All the children were administered green tea , guava  and Chlorhexidine mouthwashes according to the group they were assigned ,  5ml for 30 seconds twice daily for 21 days and again plaque index, gingival index  were  recorded. It was concluded that all the three mouthwashes were effective antiplaque and antigingivitis agent.

 
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