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临床试验/CTRI/2024/03/063965
CTRI/2024/03/063965尚未招募4 期

Comparative Evaluation of the Alveolar Ridge Preservation Following Intra Alveolar Extraction of Maxillary and Mandibular Molars With and Without the Use of Local Simvastatin: A Randomized Clinical Study.

DR CHARLOTTE SALDANHA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare efficacy of locally applied

研究概览

简要总结

Statins are specific inhibitors of 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) reductase which is involved in the conversion of HMG-CoA to mevalonate, thus reducing the hepatic synthesis of cholesterol. Simvastatin is a chemically modified statin that stimulates bone formation by increasing the gene expression of bone morphogenetic protein-2 (BMP 2) and vascular endothelial growth factor (VEGF). The time of extraction is the best time to preserve the alveolar ridge. Ridge preservation can prevent 40%–60% of the jaw bone atrophy that normally happens 2–3 years after tooth extraction. Simvastatin can be topically or systemically administered to take advantage of its anabolic effects on bone. Systemically administered simvastatin has less than 5% bioavailability due to high first pass metabolism in the liver. Hence local drug delivery systems are used to directly deliver simvastatin to the site of action. The existing methods of ridge preservation include the use of autogenous, allogenic, xenogenous grafts, and alloplasts. Autogenous bone offers osteoinduction, osteogenicity and an osteoconductive matrix that are necessary for bone repair. But disadvantages like, a second surgical site, donor site morbidity, stability of graft, storage, post-operative discomfort and increased surgical time subsequently led to the development of various alternatives like pharmacologic compounds such as simvastatin that can upregulate the necessary autogenous growth factors and will be a cost-effective way to correct bone defects. Simvastatin packed locally in extraction sockets is safe, painless, inexpensive with no side effects and improved tissue repair. This study is designed prospectively to radiographically assess the alveolar ridge preservation following intra alveolar extraction of maxillary and mandibular molars with and without the use of local simvastatin by evaluating changes in bone density, ridge width and ridge height by comparing with sockets packed with local simvastatin. The rationale of the study is to evaluate the role of simvastatin in post extraction sockets for ridge preservation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients indicated for maxillary and mandibular molar intra alveolar extraction under local anaesthesia.
  • Tooth with adjacent teeth present and intact.
  • Tooth indicated for extraction without any radiographically evident periapical lesion.
  • Patients willing to be a part of the study.

排除标准

  • Teeth which require transalveolar method of extraction under local anaesthesia.
  • Patients indicated for maxillary and mandibular third molar extractions.
  • Patients with uncontrolled periodontal diseases.
  • Patients with known allergy to statins.
  • Patients with systemic comorbidities that are contraindications for extraction and affect bone metabolism and healing.
  • Patients on steroid therapy.
  • Patients undergoing radiotherapy.
  • Smokers and Alcoholics.
  • Pregnancy based on history.

结局指标

主要结局

To evaluate and compare efficacy of locally applied

时间窗: Immediate post extraction, at 8 weeks, at 12 weeks

simvastatin in alveolar ridge preservation in post extraction sockets of maxillary and mandibular molars.

时间窗: Immediate post extraction, at 8 weeks, at 12 weeks

次要结局

  • To evaluate and compare bone density following intra(alveolar extraction of maxillary and mandibular molars with and without the use of local simvastatin.)

研究者

发起方
DR CHARLOTTE SALDANHA
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

DR CHARLOTTE SALDANHA

MGM DENTAL COLLEGE AND HOSPITAL, KAMOTHE

研究点 (1)

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