Chronic PeriodontitisPhase 2/3NCT02372656
Simvastatin and Metformin in Chronic Periodontitis
A Phase 2/3 study testing 1% Metformin and 1.2% Simvastatin in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- 1% Metformin and 1.2% Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Aug 2014
- Phase
- Phase 2/3
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy subjects
- Pocket depth ≥ 5 mm
- Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months
Who cannot join
- Subjects allergic to MF or SMV
- Those on systemic MF or SMV therapy
- Subjects with aggressive periodontitis
- Immunocompromised subjects
- Use of tobacco in any form, alcoholics
- Lactating and pregnant females
About this study
Official title: Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
Read the detailed description
Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.
Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software
Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.
Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.
- Conditions
- Chronic Periodontitis
- Being tested
- Placebo gel, 1% Metformin, 1.2% Simvastatin
- Keywords
- Simvastatin, Metformin, Chronic periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
Also called Placebo group
Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
1% MetforminDrug
Also called 1% Metformin group
1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
1.2% SimvastatinDrug
Also called 1.2% Simvastatin group
1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months. Receives: Drug: Placebo gel |
| 1% Metformin | Active comparator | 1% metformin gel to be delivered at baseline, 3, 6 and 9 months. Receives: Drug: 1% Metformin |
| 1.2% Simvastatin | Active comparator | 1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months. Receives: Drug: 1.2% Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.
Measured: Baseline to 6 months and Baseline to 9 months
Secondary outcomes (4)
Plaque index will be measured at 3, 6 and 9 months
Measured: 3,6 and 9 months
Modified sulcular bleeding index at 3, 6 and 9 months
Measured: 3 , 6 and 9 months
Probing pocket depth at 3, 6 and 9 months
Measured: 3 , 6 and 9 months
Clinical attachment level at 3, 6 and 9 months
Measured: 3 , 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372656
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/10C/2013-14
- Status last verified
- Feb 2015
- First submitted
- 30 Nov 2014
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02372656
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/10C/2013-14
- Conditions
- Chronic Periodontitis
- Keywords
- Simvastatin, Metformin, Chronic periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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.
This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.
Detailed description
Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.
Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software
Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.
Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo gelPlacebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months. |
| 1% Metformin | Active comparator | Drug: 1% Metformin1% metformin gel to be delivered at baseline, 3, 6 and 9 months. |
| 1.2% Simvastatin | Active comparator | Drug: 1.2% Simvastatin1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy subjects
- Pocket depth ≥ 5 mm
- Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months
Key exclusion criteria (6 listed)
- Subjects allergic to MF or SMV
- Those on systemic MF or SMV therapy
- Subjects with aggressive periodontitis
- Immunocompromised subjects
- Use of tobacco in any form, alcoholics
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 |
|---|---|---|
| Placebo gelAlso: Placebo groupPlacebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. | Drug | Placebo Group |
| 1% MetforminAlso: 1% Metformin group1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. | Drug | 1% Metformin |
| 1.2% SimvastatinAlso: 1.2% Simvastatin group1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months. | Drug | 1.2% Simvastatin |
Primary outcome
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months
Time frame: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.
4 secondary outcomes
Plaque index will be measured at 3, 6 and 9 months
Time frame: 3,6 and 9 months
Modified sulcular bleeding index at 3, 6 and 9 months
Time frame: 3 , 6 and 9 months
Probing pocket depth at 3, 6 and 9 months
Time frame: 3 , 6 and 9 months
Clinical attachment level at 3, 6 and 9 months
Time frame: 3 , 6 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1% Metformin and 1.2% Simvastatin in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in defect depth reduction from baseline to 6 months and from baseline to 9 months (time frame: Baseline to 6 months and Baseline to 9 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 26 Feb 2015.