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
|
|
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
|
|
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
|
|
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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