A Phase 4 interventional study of Rosuvastatin and platelet rich fibrin in Furcation Defects, sponsored by Government Dental College and Research Institute, Bangalore. Completed. Open to participants aged 26 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-23.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 4, Interventional, and Treatment
Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic statin, that stimulate bone formation in critical-size cortical bone defects adjacent to titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a platelet concentrate with sustained release of various growth factors, having regenerative potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has clinically satisfactory response, when used to fill periodontal intrabony defects. This double-masked randomized study is designed to evaluate the potency of combination of RSV 1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical treatment of mandibular degree II furcation defects when compared with autologous PRF and HA bone graft placed after open flap debridement (OFD).
ABSTRACT Background: A wide range of regenerative materials have been tried in the treatment of furcation defects. Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic statin, that stimulate bone formation in critical-size cortical bone defects adjacent to titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a platelet concentrate with sustained release of various growth factors, having regenerative potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has clinically satisfactory response, when used to fill periodontal intrabony defects. This double-masked randomized study is designed to evaluate the potency of combination of RSV 1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical treatment of mandibular degree II furcation defects when compared with autologous PRF and HA bone graft placed after open flap debridement (OFD).
Material and methods 105 patients with mandibular buccal Class II furcation defects were randomly allotted and treated either with, OFD and placebo gel: Group 1, or OFD + autologous PRF and porus-HA bone graft: Group 2, or OFD + RSV 1.2mg in situ gel combined with autologous PRF and porus-HA bone graft: Group 3. Clinical parameters were recorded at baseline before SRP and at 9 months; they included modified sulcus bleeding index (mSBI), probing depth (PD), and relative vertical (RVAL) and horizontal (RHAL) attachment levels. At baseline and after 9 months, radiographic assessment of bone defect fill was performed postoperatively.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's enrollment of 110 is above the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects 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:
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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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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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Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
furcation defect site is surgically debrid and placed a placebo gel
Following surgical debridment of furcation site autologous PRF and bone graft is placed in defect as a competator drug used is platelet rich fibrin and porus hydroxyapatite bone graft
Biological: platelet rich fibrin
Following surgical debridment of furcation site Rosuvastatin 1.2% in situ gel combined with autologous PRF and bone graft is placed
Drug: Rosuvastatin
Rosuvastatin, is a statin group of drug.
Also known as: statin
AUTOLOGUS PLATELET GROWTH FACTOR
Also known as: platelet concentrate
BONE FILL
BONE FILL/ defect depth reduction recorded at baseline and at 9 months
Time frame: 9 MONTHS
Probing depth
Probing depth recorded at baselin and at 9 months
Time frame: 9 months
Clinical attachment level
Gain in Clinical attachment level from cementoenamel junction to the base of the periodontal pocket
Time frame: 9 months
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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rosuvastatin
Government Dental College and Research Institute, Bangalore