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Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects

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ClinicalTrials.gov Identifier: NCT02369250
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Furcation Defects Drug: Rosuvastatin Biological: platelet rich fibrin Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rosuvastatin 1.2mg in Situ Gel Combined With 1:1 Mixture of Autologous Platelet-rich Fibrin and Porus- Hydroxyappatite Bone Graft in Surgical Treatment of Mandibular Degree II Furcation Defects: A Randomized Clinical Control Trial
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Placebo Comparator: OFD+ PLACEBO GEL
furcation defect site is surgically debrid and placed a placebo gel
Active Comparator: OFD+ PRF + BONE GRAFT
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
AUTOLOGUS PLATELET GROWTH FACTOR
Other Name: platelet concentrate

Experimental: RSV1.2% gel + PRF+ BG
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.
Other Name: statin




Primary Outcome Measures :
  1. BONE FILL [ Time Frame: 9 MONTHS ]
    BONE FILL/ defect depth reduction recorded at baseline and at 9 months


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: 9 months ]
    Probing depth recorded at baselin and at 9 months

  2. Clinical attachment level [ Time Frame: 9 months ]
    Gain in Clinical attachment level from cementoenamel junction to the base of the periodontal pocket



Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD ± 5mm and horizontal PD ± 3mm after Phase I therapy (SRP)
  2. no history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

  1. systemic illness known to affect the outcomes of periodontal therapy, such as diabetes mellitus, cardiac diseases, insufficient platelet count (<200,000/mm3), or immunocompromised (e.g., HIV individuals) patients taking medications, such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing
  2. individuals known or suspected allergy to the RSV group or allergic to medications
  3. systemic statin therapy
  4. pregnant or lactating women
  5. patients using tobacco in any form
  6. individuals with unacceptable oral hygiene (plaque index >1.5). In addition, teeth with interproximal intrabony defects, gingival recession, endodontic (pulpal) involvement, or mobility of tooth ≥ Grade II were also excluded.

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Responsible Party: Dr. A R Pradeep, Proffesor and Head, dept of periodontology, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02369250    
Other Study ID Numbers: GDCRI/ACM/PG/PhD/12/2013-14
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
regeneration
surgical therapy
furcation defect
Additional relevant MeSH terms:
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Furcation Defects
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors