Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft on Osseointegration of Immediate Dental Implants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Implant Stability (ISQ)
研究概览
简要总结
Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. The aim of this study is to evaluate clinically and radiographically the efficacy of injectable bone graft versus ozonated olive oil gel to promote bone formation and improve outcomes in immediate implant cases. 16 immediate implants will be placed in mandibular premolar region the study will be devided equally and randomlly into two groups , Group 1: it will be 8 immediate implants represent the control group were the implants will be placed with injectable bone graft , Group 2: will be 8 immediate implant represent the study group were the implants will be placed with ozonated olive oil gel be used as a graft material . The implant stability will be assessed clinically using Ostell , and the bone density will be assed radiographically .
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 20 and 60 years.
- •Adults of both genders.
- •Patients who are medically healthy and without systemic conditions that could contraindicate implant placement.
- •Patients requiring extraction of a single unrestorable mandibular premolar indicated for immediate implant placement.
- •Presence of sufficient apical and peripheral bone to achieve primary implant stability (minimum 3-5 mm of bone beyond the socket apex and overall socket length ≥ 10 mm).
排除标准
- •Pregnant and lactating women's
- •Heavy smoking (>10 cigarettes/day)
- •Severe parafunctional habits (e.g., uncontrolled bruxism).
- •Periapical infections or lesions.
- •Gingival and periodontal diseases.
- •Inability or unwillingness to attend scheduled follow-up visits.
研究组 & 干预措施
Group I (Control Group)
8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.
干预措施: Immediate implant placement (Procedure)
Group I (Control Group)
8 implants were inserted immediately after teeth extraction with grafting of injectable β-tricalcium phosphate (β-TCP) bone graft around the implant.
干预措施: β-tricalcium phosphate Injectable Bone Graft (Biological)
Group II (Study Group)
8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.
干预措施: Immediate implant placement (Procedure)
Group II (Study Group)
8 implants were inserted immediately after teeth extraction with grafting of ozonated olive oil gel around the implant.
干预措施: Ozonated olive oil gel (Biological)
结局指标
主要结局
Implant Stability (ISQ)
时间窗: Baseline, and 6 months postoperatively
Osstell enables precise and objective monitoring of osseointegration and implant stability through non-invasive measurements. A cable-connected probe requires a smart peg to be securely attached to the implant. When using the device, it should be held at a right angle to the implant, with a maximum deviation of 45 degrees and a distance of 0.6-2.5 mm from the test surface. The implant stability is measured using the ISQ scale, ranging from 1 to 100, where values above 70 indicate strong stability, 60-69 indicate medium stability, and lower values suggest lower stability. Measurements are taken immediately postoperatively and reassessed after 6 months for final stability confirmation.
Bone density
时间窗: Baseline, 3 and 6 months postoperatively
Direct paralleling digital periapical radiographs were obtained using the KaVo Scan eXam™ One system and the Rinn extension cone paralleling device. The KaVo system employs a thin, flexible, wireless phosphorescent imaging plate, and the imaging plate size 2 has a specific active surface area and resolution. A long cone was attached to the x-ray tube, and fixed exposure parameters were applied throughout the study. Radiographic assessments occurred immediately post-operative and after 3 and 6 months. Image analysis utilized IDRISI Kilimanjaro software for restoration, enhancement, and densitometric measurements. This software uniquely monitored changes in bone density in two zones: the osseointegration zone near the implant border and the surrounding bone interface.
次要结局
- Visual Analogue Scale of Pain (VAS)(Days 1, 3, and 7 postoperatively)
- Visual Scale of Edema(Days 1, 3, and 7 postoperatively)