A Phase 2/3 interventional study of Placebos and Rosuvastatin in Chronic Periodontitis, sponsored by Government Dental College and Research Institute, Bangalore. Completed. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) have shown to have bone stimulatory and anti-inflammatory effects.Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of intrabony defects.
Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) have shown to have bone stimulatory and anti-inflammatory effects.Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1MF gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of intrabony defects.
Methods: Ninety patients with intrabony defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1% MF gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were delivered at the respective sites at baseline . Then again all clinical and radiographic parameters were recorded after 6 months and 12 months.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's enrollment of 90 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:
patients with systemic diseases like cardiovascular disease diabetes or infection or on medications like which may impede the healing in periodontal tissues.
pregnant/lactating females tobacco users alcoholics patients with unsatisfactory oral hygiene (plaque index greater than 1.5) teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility Furthermore, patients allergic to Metformin and rosuvastatin or those taking Metformin and rosuvastatin systemically were excluded.
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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.
The human immunodeficiency virus, which weakens the immune system.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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 placebo gel local drug delivery
Drug: Placebos
SRP followed by 1.2% rosuvastatin (RSV) gel
Drug: Rosuvastatin
SRP followed by 1% Metformin ( MF) gel
Drug: Metformin
Oral prophylaxis followed by placement of placebo gel
Also known as: Inactive drug
Oral prophylaxis followed by placement of rosuvastatin gel
Also known as: RSV
Oral prophylaxis followed by placement of metformin gel
Also known as: MF
Change in Bone defect fill
Assessed in percentage
Time frame: baseline, 6 & 12 months
Change in modified sulcus bleeding index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in Plaque index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in pocket probing depth
measured in mm
Time frame: baseline, 6 & 12 months
Change in clinical attachment level
measured in mm
Time frame: baseline, 6 & 12 months
change in intrabony defect depth
measured in mm ( Radiograph)
Time frame: baseline, 6 & 12 months
No study locations are listed for this record.
Ran from Feb 2016 to primary completion in Feb 2017, 12 months.
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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rosuvastatin · Metformin
Government Dental College and Research Institute, Bangalore