Home » Trials » SLCTR/2010/012
A randomized double -blind placebo-controlled study on therapeutic effects of a herbal toothpaste (sudantha) after 6 months use in patients with chronic gingivitis
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SLCTR Registration Number
SLCTR/2010/012
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A randomized double -blind placebo-controlled study on therapeutic effects of a herbal toothpaste (sudantha) after 6 months use in patients with chronic gingivitis
Public Title of Trial
Effect of the use of a herbal toothpaste on gum disease
Disease or Health Condition(s) Studied
Chronic gingivitis
Scientific Acronym
None
Public Acronym
None
Brief title
Herbal toothpaste trial on patients with gingivitis
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
FDS-FRC/2011/02 (Approved - Faculty Research Committee, Faculty of Dental Sciences, University of Peradeniya)
What is the research question being addressed?
Is Sudantha toothpaste effective in the management of patients with chronic gingivitis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Tooth brushing with a placebo, ( 4 ) Sudantha or another commercially available toothpaste
Inclusion criteria
Patients oner 18 years with mild to moderate chronic gingivitis with no co-morbidities
Exclusion criteria
Presence of co-morbidities current users of herbal toothpastes.
Primary outcome(s)
|
1.
Total salivary bacterial counts Gingival bleeding on probing, pocket depth plaque score at 6,12,18,24 weeks after using 1) placebo2) Sudantha 3) positive control toothpaste. ( Commercially available toothpaste ) |
[ At Baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks after commencement of the trial ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
30 participants in each arm
Countries of recruitment
Sri Lanka
Anticipated start date
2010-12-16
Anticipated end date
2011-12-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Link Natural Products (Pvt) Ltd
Regulatory approvals
Status
Approved
Date of Approval
2010-08-18
Approval number
FDS-RERC/2010/02
Details of Ethics Review Committee
| Name: | Research and Ethical Review Committee, Faculty of Dental Sciences, University of Peradeniya |
| Institutional Address: | Peradeniya, 20400, Sri Lanka |
| Telephone: | +94-812397552 |
| Email: | sunethraj@pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Sunethra Rajapakse
Professor in Periodontology
Faculty of Dental Sciences, University of Peradiniya
0812397552 0812388948
sunethraraj@pdn.ac.lk
Contact Person for Public Queries
Sunethra Rajapakse
Professor in Periodontology
Faculty of Dental Sciences, University of Peradiniya
0812397552 0812388948
sunethraraj@pdn.ac.lk
Primary study sponsor/organization
Link Natural Products (Pvt) Ltd
CIC House, 199, Kew Road, Colombo 02
011 2409294 011 2409293
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
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
