Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.

Periodontitis Clinical Trial

Official title:

Efficacy of Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetic Patients With Periodontitis-A Split Mouth Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381598
• Other study ID #: SVSIDS/perio/3/2019
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: November 2021

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PHD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: November 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Drug:
• stevia rebaudiana bertoni
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.

Other:
• placebo
A placebo without the active drug will be placed in the control sites.

Locations

Country	Name	City	State
India	SVS Institute Of Dental Sciences	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bio-marker (Ghrelin) levels in Gingival crevicular fluid.	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.	From baseline to 6-months.
Secondary	Probing depth	Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm.	From baseline to 6-months.