PeriodontitisPhase 2NCT04381598
Stevia Rebaudiana Bertoni on Levels of GCF Glucose and Bio-markers in Diabetics.
A Phase 2 study testing stevia rebaudiana bertoni in people with Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- stevia rebaudiana bertoni
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2019to Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
SVS Institute Of Dental Sciences
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PHD, 9908183071, viswachandra@hotmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- stevia rebaudiana bertoni, placebo
- Keywords
- Biomarkers, Gingival crevicular fluid, Glucose, Diabetes
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stevia rebaudiana bertoniDrug
Also called sweet tulasi
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.
placeboOther
Also called Control group
A placebo without the active drug will be placed in the control sites.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6-months.
Secondary outcomes (1)
Probing depth
Probing depth (PD): Distance from the gingival margin to the bottom of gingival sulcus in mm.
Measured: From baseline to 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Apr 2019
- Primary completionOct 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group of subjects receives intervention where as other group of subjects receive placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381598
- Sponsor's protocol ID
- SVSIDS/perio/3/2019
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04381598
- Acronym / sponsor ID
- SVSIDS/perio/3/2019
- Conditions
- Periodontitis
- Keywords
- Biomarkers, Gingival crevicular fluid, Glucose, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- one group of subjects receives intervention where as other group of subjects receive placebo.
| Arm | Type | Receives |
|---|---|---|
| stevia rebaudiana bertoni | Experimental | Drug: stevia rebaudiana bertoniRandomly 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 comparator | Other: placeboOther 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stevia rebaudiana bertoniAlso: sweet tulasiStevia 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. | Drug | stevia rebaudiana bertoni |
| placeboAlso: Control groupA placebo without the active drug will be placed in the control sites. | Other | placebo |
Primary outcome
Bio-marker (Ghrelin) levels in Gingival crevicular fluid.
Time frame: 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.
1 secondary outcome
Probing depth
Time frame: From baseline to 6-months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stevia rebaudiana bertoni in people with Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R V Chandra, MDS;DNB;PHD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bio-marker (Ghrelin) levels in Gingival crevicular fluid. (time frame: From baseline to 6-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.