A Phase 2/3 interventional study of ATORVASTATIN and SIMVASTATIN in Chronic Periodontitis Wth Diabetes Mellitus, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-19.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
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).
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.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's enrollment of 120 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery
Drug: ATORVASTATIN
Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery
Drug: SIMVASTATIN
Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: PLACEBO
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
Also known as: ATV
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
Also known as: SMV
Scaling and Root Planing (SRP) followed by placement of placebo gel
Also known as: inactive drug
change in defect depth
assessed in percentage
Time frame: 6 and 9 months
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
Ran from Mar 2017 to primary completion in Dec 2017, 9 months.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atorvastatin · Simvastatin
Government Dental College and Research Institute, Bangalore