Home » Trials » SLCTR/2011/007
Effects of an eugenol containing toothpaste Clogard ® after three months use in patients with chronic gingivitis
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SLCTR Registration Number
SLCTR/2011/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effects of an eugenol containing toothpaste Clogard ® after three months use in patients with chronic gingivitis
Public Title of Trial
Effects of an eugenol containg toothpaste Clogard on gum disease
Disease or Health Condition(s) Studied
Chronic gingivitis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
FDS-FRC/2011/06 (Faculty Research Committee, Faculty of Dental Sciences, University of Peradeniya)
What is the research question being addressed?
Is Clogard ® toothpaste useful in the management of Chronic gingivitis ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Toothbrushing with a placebo or Clogard ® toothpaste for three months
Inclusion criteria
Patients over 18 years of age with no co-morbidities
Exclusion criteria
presence of co-morbidities, current users of eugenol containing toothpastes or herbal toothpastes
Primary outcome(s)
|
1.
Gingival bleeding on probing, probing pocket depth, plaque score, aerobic and anaerobic salivary bacterial counts at 4, 8 and 12 weeks Gingival crevicular fluid volume in relation gingival pocket of two selected teeth baseline 4 weeks, 8 weeks and 12 weeks |
[ Baseline,and at 4, 8 and 12 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
2011-06-20
Anticipated end date
2012-12-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Hemas Manufacturing Pvt Ltd, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2011-03-31
Approval number
FDS-FRC/2011/06
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
Prof. Sunethra Rajapakse
Professor in Periodontology
Faculty of Dental Science, University of Peradeniya
0812397552 0812388948
sunethraraj@pdn.ac.lk
Contact Person for Public Queries
Prof. Sunethra Rajapakse
Professor in Periodontology
Faculty of Dental Science, University of Peradeniya
0812397552 0812388948
sunethraraj@pdn.ac.lk
Primary study sponsor/organization
Hemas Manufacturing Pvt Ltd
Hemas innovation Centre, Dankotuwa
0314877877 0314877878
hemalal.consumer@hemas.com
http://www.hemas.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
