Chronic Periodontitis Wth Diabetes MellitusPhase 2/3NCT03745300
Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
A Phase 2/3 study testing ATORVASTATIN and SIMVASTATIN in people with Chronic Periodontitis Wth Diabetes Mellitus, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
Trial summary
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal… Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis Wth Diabetes Mellitus
- What is being tested?
- ATORVASTATIN and SIMVASTATIN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2017to 22 Dec 2017
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy
Who cannot join
- 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontics, GDCRI Bangalore
Bangalore, Karnataka, 560002
About this study
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
Read the detailed description
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
- Being tested
- ATORVASTATIN, SIMVASTATIN, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATORVASTATINDrug
Also called ATV
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
SIMVASTATINDrug
Also called SMV
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
PLACEBODrug
Also called inactive drug
Scaling and Root Planing (SRP) followed by placement of placebo gel
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Active comparator | Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery Receives: Drug: ATORVASTATIN |
| GROUP 2 | Active comparator | Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery Receives: Drug: SIMVASTATIN |
| GROUP 3 | Placebo comparator | Scaling and root planing (SRP) followed by placebo gel local drug delivery Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in defect depth
assessed in percentage
Measured: 6 and 9 months
Secondary outcomes (4)
change in probing depth (PD)
Measured: baseline, 6 and 9 months
change in Clinical Attachment Level (CAL)
Measured: baseline, 6 and 9 months
CHANGE IN Plaque Index (PI)
Measured: baseline, 6 and 9 months
change in modified Sulcus Bleding Index (mSBI)
Measured: baseline, 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 posted19 Nov 2018
- Study start3 Mar 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis Wth Diabetes MellitusStudies 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
- 120 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
- Investigators
- Avani R Pradeep, MDS, Principal investigator, GDCRI, Bangalore, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745300
- Sponsor's protocol ID
- GDCRI/ACM/PG/Ph.D/5/2016-2017H
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03745300
- Acronym / sponsor ID
- GDCRI/ACM/PG/Ph.D/5/2016-2017H
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 19 Nov 2018 (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.
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
Detailed description
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Active comparator | Drug: ATORVASTATINScaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery |
| GROUP 2 | Active comparator | Drug: SIMVASTATINScaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery |
| GROUP 3 | Placebo comparator | Drug: PLACEBOScaling and root planing (SRP) followed by placebo gel local drug delivery |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy
Key exclusion criteria (1 listed)
- 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.
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 |
|---|---|---|
| ATORVASTATINAlso: ATVScaling and Root Planing (SRP) followed by placement of atorvastatin gel | Drug | GROUP 1 |
| SIMVASTATINAlso: SMVScaling and Root Planing (SRP) followed by placement of simvastatin gel | Drug | GROUP 2 |
| PLACEBOAlso: inactive drugScaling and Root Planing (SRP) followed by placement of placebo gel | Drug | GROUP 3 |
Primary outcome
change in defect depth
Time frame: 6 and 9 months
assessed in percentage
4 secondary outcomes
change in probing depth (PD)
Time frame: baseline, 6 and 9 months
change in Clinical Attachment Level (CAL)
Time frame: baseline, 6 and 9 months
CHANGE IN Plaque Index (PI)
Time frame: baseline, 6 and 9 months
change in modified Sulcus Bleding Index (mSBI)
Time frame: baseline, 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 19 Nov 2018.
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.
Avani R Pradeep, MDS principal investigator
GDCRI, Bangalore, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ATORVASTATIN and SIMVASTATIN in people with Chronic Periodontitis Wth Diabetes Mellitus, run by Government Dental College and Research Institute, Bangalore 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 1 inclusion and 1 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 19 Nov 2018. 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 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 (time frame: 6 and 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 19 Nov 2018.