Back to resultsStevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.
Primary Purpose
Periodontitis
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
stevia rebaudiana bertoni
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Periodontitis focused on measuring Biomarkers, Gingival crevicular fluid, Glucose, Diabetes
Eligibility Criteria
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.
Sites / Locations
- SVS Institute Of Dental SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
stevia rebaudiana bertoni
placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Probing depth
Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm.
Full Information
NCT ID
NCT04381598
First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
SVS Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04381598
Brief Title
Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Biomarkers, Gingival crevicular fluid, Glucose, Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
one group of subjects receives intervention where as other group of subjects receive placebo.
Masking
ParticipantInvestigator
Masking Description
Both stevia gel and placebo syringes are masked from participants and investigators.
Allocation
Randomized
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stevia rebaudiana bertoni
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
stevia rebaudiana bertoni
Other Intervention Name(s)
sweet tulasi
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
Control group
Intervention Description
A placebo without the active drug will be placed in the control sites.
Primary Outcome Measure Information:
Title
Bio-marker (Ghrelin) levels in Gingival crevicular fluid.
Description
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.
Time Frame
From baseline to 6-months.
Secondary Outcome Measure Information:
Title
Probing depth
Description
Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm.
Time Frame
From baseline to 6-months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R V Chandra, MDS;DNB;PHD
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Information:
Facility Name
SVS Institute Of Dental Sciences
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R V Chandra, MDS;DNB;PHD
Phone
9908183071
Email
viswachandra@hotmail.com
12. IPD Sharing Statement
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Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.
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