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临床试验/NCT03009097
NCT03009097已完成4 期

"Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study

Kamineni Institute of Dental Sciences0 个研究点目标入组 26 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
26
主要终点
bone fill in mm was measured by taking radiographs

研究概览

简要总结

Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction.

Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties.

Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts.

Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.

详细描述

A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups.

Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel.

Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy individual based on personal and medical history.
  • Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss.

排除标准

  • Patients diagnosed and treated for systemic disease
  • Pregnant and Lactating women
  • History of allergy to statin group or patients on systemic statin therapy.
  • History of antibiotic or periodontal therapy for the past 6 months.

研究组 & 干预措施

DFDBA

Active Comparator

13 intrabony defects in chronic periodontitis patients were treated with DFDBA

干预措施: DFDBA (Biological)

DFDBA with Atorvastatin

Active Comparator

13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.

干预措施: DFDBA with atorvastatin (Drug)

结局指标

主要结局

bone fill in mm was measured by taking radiographs

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ETIKA RATHI

Principal investigator

Kamineni Institute of Dental Sciences

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