Periodontitis
Conditions
Keywords
Biomarkers, Gingival crevicular fluid, Glucose, Diabetes
Brief summary
With the increase in the incidence of diabetes and obesity, among other artificial sweeteners the need of natural non-caloric sweetener with acceptable taste and without any adverse effects is demanding.So,the use of stevia presents beneficial effects to general and oral health and its properties could result potentially effective in the treatment of periodontal diseases.
Detailed description
Stevia is considered as a novel molecule, because it is 100% natural and non caloric sweetener, with more sweetness than sucrose, without any adverse effects. It also demonstrates multiple benefits like anti-plaque effect, anti-diabetic effect, anti-periodontophatics properties, anti-hypertensive properties, anti-cariogenic properties etc. There are many studies conducted on stevia in humans, which justifies my study.
Interventions
Stevia has an anti-plaque effect because of its ability in decreasing the formation of bacterial insoluble polymers.It significantly decreases the production of TNF-R and IL-1a and slightly decreases the production of NO in stimulated cells with LPS and THP-1 showing its anti-inflammatory properties.These characteristics in combination with anti-diabetic properties could results in the effective treatment of periodontal diseases.
OTHERplacebo
A placebo without the active drug will be placed in the control sites.
Sponsors
SVS Institute of Dental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Both stevia gel and placebo syringes are masked from participants and investigators.
Intervention model description
one group of subjects receives intervention where as other group of subjects receive placebo.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects that will be included in the study are in the age group ranging from 20-70 years -with established diabetes and under medication to maintain normal glycemic state i.e;Hb1Ac \< 7％. * Oral findings including the presence of minimum of 16 natural teeth with minimum of 4 nonadjacent sites showing pocket depths≥ 5 mm.
Exclusion criteria
Subjects will be excluded from the study if they are using * any type of mouth-rinses or if they had underwent any periodontal therapy within the 3-months of the study or * if they were under antibiotics within the 3-months of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bio-marker (Ghrelin) levels in Gingival crevicular fluid. | From baseline to 6-months. | GCF samples can be eluted from the strips by placing them in Eppendrof® tubes that contained 500 micro-litre of buffer and will be stored at -80℃ until analysis was done. The levels of GCF Ghrelin will be evaluated by using commercially available ELISA kit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | From baseline to 6-months. | Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm. |
Countries
India
Contacts
Primary ContactR V Chandra, MDS;DNB;PHD
Outcome results
None listed