| 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 (in lay language) | Effect of the use of a herbal toothpaste on gum disease | |
| Acronym, if any | None | |
| Brief title, if any | Herbal toothpaste trial on patients with gingivitis | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Chronic Gingivitis | |
| What is the research question being addressed? | Is Sudantha toothpaste effective in the management of patients with chronic gingivitis? | |
| Study design | randomized double-blind placebo-controlled clinical trial | |
| 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. | |
| Target number / sample size | 30 participants in each arm | |
| Primary outcome(s) | 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 ) | |
| Primary outcome(s) - time of assessment(s) | At Baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks after commencement of the trial | |
| Secondary outcome(s) | None | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 16/12/2010 | |
| Anticipated end date | 01/12/2011 | |
| Recruitment status | Recruiting | |
| State of ethics review approval | Approval obtained from by Faculty of Dental Sciences - Ethics Committee | |
| Funding source(s) | Link Natural Products (Pvt) Ltd | |
| Applicant's Email | sunethraraj@pdn.ac.lk | |
| Approval Status | Approved | |
| 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 |
|
| 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 |
|
| Contact Person for Public Queries | Sunethra Rajapakse Professor in Periodontology Faculty of Dental Sciences, University of Peradiniya 081 2397552 081 2388948 sunethraraj@pdn.ac.lk |
|
| Secondary Study Sponsor(s), (if any) | None |
|
