| CTRI Number |
CTRI/2019/01/016897 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
27/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of toothpaste containing mango twig and market available toothpaste on oral bacteria and debris among 12-15 years old children in Davangere city. |
|
Scientific Title of Study
|
Comparison of efficacy of dentifrices containing mangifera indica extract and fluoride on salivary streptococcus mutans count and plaque accumulation among 12 – 15 years school children in Davangere city – A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anindita Dutta |
| Designation |
Post Graduate Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Public Health Dentistry
Bapuji Dental College and Hospital
MCC B Block, Davangere
-
Davanagere
KARNATAKA
577004
India |
| Phone |
9167119073 |
| Fax |
|
| Email |
anindita.03.dutta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna B |
| Designation |
Reader |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Public Health Dentistry
Bapuji Dental College and Hospital
MCC B Block, Davangere
-
Davanagere
KARNATAKA
577004
India |
| Phone |
9448038191 |
| Fax |
|
| Email |
sapnaprasanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna B |
| Designation |
Reader |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Department of Public Health Dentistry
Bapuji Dental College and Hospital
MCC B Block, Davangere
-
Davanagere
KARNATAKA
577004
India |
| Phone |
9448038191 |
| Fax |
|
| Email |
sapnaprasanna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and Hospital, Davangere |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Anindita Dutta |
Bapuji Dental College and Hospital |
MCC B Block Davangere
Davanagere
KARNATAKA |
9167119073
anindita.03.dutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional review board Bapuji Dental college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TEST DENTIFRICE- Mangifera indica extract |
Composition include all the basic ingredients of toothpaste and therapeutic agent as Mangifera indica extract at a concentration of 0.2%w/w
To be used twice daily for 21 days |
| Comparator Agent |
Fluoridated dentifrice: |
Commercially available fluoridated toothpaste (Colgate total care) will be used as positive control. Colgate total care toothpaste contains 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a silica base.
To be used twice daily for 21 days |
| Comparator Agent |
Placebo dentifrice |
Composition is same as test dentifrice, except the therapeutic agent Mangifera indica extract
To be used twice daily for 21 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects whose parents will give consent for their children to participate in study.
2. Subjects having at least one cavitated active carious lesion
A cavitated active lesion – is a well-defined cavity with exposed dentin, yellowish or light brown in colour, which feels soft on gentle probing.
3. Having a streptococcus mutans count of equal to or more than 105 CFU per ml of saliva (microbiological selection criteria)
4. Subjects with a baseline mean plaque index score of at least 1.5 as determined by the use of the Turesky modification of the Quigley-Hein Plaque Index.
5. Subjects with presence of more than 20 scoreable teeth in the oral cavity
|
|
| ExclusionCriteria |
| Details |
1. Subjects on medications and subjects with systemic diseases that affect their salivary flow rate.
2. History of hypersensitivity to any product used in the study
3. History of antibiotic therapy in the previous one month till the start of the study.
4. Subjects who will be unable to comply with the study appointment
Schedules
5. Subjects using orthodontic appliances
6. Subjects using adjunctive oral hygiene aid like mouthwash
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess and compare the antiplaque and antibacterial efficacy of Mangifera indica extract dentifrice, commercially available Fluoridated dentifrice (Colgate total care) and a Placebo dentifrice on salivary Streptococcus mutans levels and plaque levels among 12 – 15 years old school children in Davanagere city |
1. 21 days after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/01/2019 |
| 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="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
This is a randomized, triple blinded, parallel group
trial to evaluate the efficacy
of dentifrices containing mangifera
indica extract and fluoride
on salivary streptococcus mutans
count and plaque accumulation
among
12 – 15 years school children in
Davangere city. A Two
stage random sampling method
will be followed for recruitment of participans. Sample size
calculation was
done using G Power software by fixing the effect size at 0.4. 84 participants were equally divided into
3 groups containing test group , placebo group and control group. Baseline and post-test assessment will be done after 3 weeks, for
streptococcus mutans count and Plaque score will be assessed by applying
Turesky Gilmore Glickman modification of
the Quigley Hein Plaque index.
Comparison of salivary streptococcus mutans
counts and plaque scores within group
will be done by Students paired ‘t’ test and comparison of salivary streptococcus mutans
counts and plaque score will be done at baseline and after 3 weeks for three dentifrices using one way ANOVA followed by post hoc
Tukey’s test .
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