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SLCTR Registration Number
Date of Registration
The date of last modification
Jul 14, 2012
View original TRDS
Scientific Title of Trial
A randomized double- blind, placebo- controlled study on the effects of a herbal toothpaste ( Sudantha ®) on gingival, oral hygiene and microbial parameters
Public Title of Trial
A controlled trial of a herbal Ayurvedic toothpaste (Sudantha ®)
Disease or Health Condition(s) Studied
Oral and gingival hygiene
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is Link Sudantha effective in protecting oral and gingival health?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Purpose
Study Phase
Phase 2-3
Intervention(s) planned
Tooth brushing with placebo or Sudantha toothpaste.
Inclusion criteria
Healthy volunteers over 18 years of age with no co-morbidities, with similar plaque and gingival bleeding.
Exclusion criteria
Presence of co-morbidities, current users of herbal toothpaste
Primary outcome(s)
|
1.
1.Total salivary bacterial counts (aerobic and anaerobic) 2.Plaque score. 3.Gingival bleeding. |
[ One, two and three months after using Placebo or Sudantha toothpaste ] |
|
2.
Plaque score. |
[ One, two and three months after using Placebo or Sudantha toothpaste ] |
|
3.
Gingival bleeding. |
[ One, two and three months after using Placebo or Sudantha toothpaste ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
30 participants in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2010-04-01
Anticipated end date
2009-07-30
Date of first enrollment
Date of study completion
Recruitment status
5
Funding source
Link Natural Products (Pvt) Ltd, 199, Kew Road, Colombo 02, Sri Lanka
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Professor Sunethra Rajapakse
Professor in Periodontology Faculty of Dental Science, University of Peradeniya
Faculty of Dental Science, University of Peradeniya, Sri Lanka.
081 - 2397552 081 - 2388948
sunethraraj@pdn.ac.lk
Contact Person for Public Queries
Professor Sunethra Rajapakse
Professor in Periodontology Faculty of Dental Science, University of Peradeniya
Faculty of Dental Science, University of Peradeniya, Sri Lanka.
081 - 2397552 081 - 2388948
sunethraraj@pdn.ac.lk
Primary study sponsor/organization
Link Natural Products (Pvt) Ltd
199, Kew Road, Colombo 02, Sri Lanka
0112409294 0112409293
info@linknaturalproducts.com
www.linknaturalproducts.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
