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

Phase 2

• Conditions: Periodontitis
• Interventions: Drug: stevia rebaudiana bertoni; Other: placebo

• Registration Number: NCT04381598
• Lead Sponsor: SVS Institute of Dental Sciences

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11
• Primary Completion: 2020-10
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stevia rebaudiana bertoni	stevia rebaudiana bertoni	Randomly in all subjects one quadrant will be allotted as test site for placing stevia gel in the gingival sulcus having probing depth ≥ 5mm after performing thorough scaling and root planing.
placebo	placebo	Other quadrant will be allotted as a control site for placing placebo in the gingival sulcus having PD≥ 5mm after performing thorough scaling and root planing.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Probing depth	From baseline to 6-months.	Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm.

Trial Locations

Locations (1)

SVS Institute Of Dental Sciences; 🇮🇳 Hyderabad, Telangana, India