The Effect of Locally Applied Gel-Based Simvastatin on Dental Implant Stability and Marginal Bone Level : A Randomized Controlled Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Implant Stability Quotient (ISQ)
研究概览
简要总结
stability and marginal bone level. Forty-two patients received dental implants and were randomly assigned to two groups. In the test group, 1.2% simvastatin in 4% methylcellulose gel was applied around the implant, while in the control group, methylcellulose gel alone was used. Implant stability was measured using resonance frequency analysis at baseline, 8 weeks, and 16 weeks. Marginal bone level was assessed by cone-beam computed tomography (CBCT) at baseline and 16 weeks. The aim of the study was to investigate whether local application of simvastatin enhances osseointegration and reduces marginal bone loss compared to the control treatment.
详细描述
ental implant stability is a key factor for the long-term success of implant therapy. Stability depends initially on primary mechanical fixation and later on secondary biological osseointegration. Various pharmacological agents have been suggested to promote bone formation around implants, including statins. Statins, primarily used as lipid-lowering agents, also demonstrate pleiotropic effects, such as stimulating bone morphogenetic protein-2 (BMP-2) expression and enhancing osteoblastic differentiation.
This randomized, double-blind, controlled clinical trial was designed to evaluate the effect of locally applied simvastatin gel on implant stability and marginal bone level. A total of 42 patients requiring single dental implants were enrolled. Participants were randomly allocated into two groups:
Simvastatin group (test): Implants placed with local application of 1.2% simvastatin in 4% methylcellulose gel.
Control group: Implants placed with local application of 4% methylcellulose gel only.
Implant stability quotient (ISQ) values were recorded at the time of implant placement (baseline), at 8 weeks, and at 16 weeks using resonance frequency analysis (RFA). Cone-beam computed tomography (CBCT) scans were performed immediately after implant placement and at 16 weeks to measure marginal bone level changes at buccal, mesial, and distal aspects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design was implemented to ensure that participants, care providers, investigators, and outcome assessors were unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients ≥ 18 years of either gender.
- •Having missing teeth in maxillary jaw maxillary jaw( premolar and molar area) at least 6 months after teeth extraction.
- •Patients who had alveolar ridges of sufficient vertical and horizontal dimensions and were considered surgically straight forward cases according to SAC classification
排除标准
- •Patients with signs of acute or chronic infection in the implant zone
- •Patients with signs of parafunctional habits
- •Patients with history of systemic diseases or recent radiotherapy to the head and neck or chemotherapy.
- •Patients who had history or were currently under treatment with oral or intravenous bisphosphonate or statins other drugs that may alter bone metabolism
- •Patients who are heavy smoker or presented with severe periodontitis.
- •Pregnant patients.
研究组 & 干预措施
Simvastatin Gel Group
Participants received dental implants with a single local application of 1.2% simvastatin in 4% methylcellulose gel applied around the implant site immediately after implant placement and prior to flap closure.
干预措施: Simvastatin Gel (Drug)
Control Gel Group
articipants received dental implants with a single local application of 4% methylcellulose gel without simvastatin, applied around the implant site immediately after implant placement and prior to flap closure.
干预措施: Methylcellulose Gel (Drug)
结局指标
主要结局
Implant Stability Quotient (ISQ)
时间窗: Baseline, 8 weeks, and 16 weeks
Implant stability was assessed using resonance frequency analysis (Osstell device). ISQ values were recorded at baseline (implant placement), 8 weeks, and 16 weeks postoperatively.
次要结局
- Marginal Bone Level (MBL)(Baseline and 16 weeks)
研究者
Maha Zuhair
Maha Zuhair Ahmed Al-Chalabi
University of Baghdad