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

NCT04381598 | Unknown Phase 2 DMC

• 1 other identifier: SVSIDS/perio/3/2019
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Biomarkers; Gingival crevicular fluid; Glucose; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Probing depth

  From baseline to 6-months.

Study Arms (2)

stevia rebaudiana bertoni

EXPERIMENTAL

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.

Drug: stevia rebaudiana bertoni

placebo

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

stevia rebaudiana bertoni DRUG

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.

Also known as: sweet tulasi

stevia rebaudiana bertoni

placebo OTHER

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

Also known as: Control group

placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute Of Dental Sciences

Hyderabad, Telangana, 509002, India

RECRUITING

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

R V Chandra, MDS;DNB;PHD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both stevia gel and placebo syringes are masked from participants and investigators.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: one group of subjects receives intervention where as other group of subjects receive placebo.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 11, 2020
• Study Start: April 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2021
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

IN (1)