The Impact of Ozone Gel on the Bone Height and Density After Closed Sinus Lifting with Simultaneous Implant Placement: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Implant stability
研究概览
简要总结
Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously..
Materials and Methods: A total of 30 sinuses with an average residual alveolar bone height ranging from 4-7 mm participated in this randomized controlled clinical trial. After closed sinus lift operation, patients were randomly and equally allocated into control group and ozone gel recipient group. Cone beam computed tomography was performed immediately and at 4 months postoperatively. Bone stability was measured immediately and at 3 & 4 months postoperatively. Bone height and stability were evaluated radiographically, and bone stability was measured using the Osstell device.
详细描述
Concern over biological augmentations used in bone healing has grown in recent years. One of the essential demands in sinus lifting procedure is to speed up the bone formation and enhance the quality of the formed bone in the space created after sinus elevation. Since more than 100 years medical grade ozone has been used as one of the non-medication methods of treatment. E. A. Fisch in the 1930's was the first dentist to use ozone therapy in his practice to aid in disinfection and wound healing. Current ozone uses a mixture of ozone gel and pure oxygen, with today's medical ozone generators which regulate the flow of medical grade O2 through high voltage tubes which is capable of producing pure ozone-oxygen mixtures in precise dosages.
Nevertheless, there is not enough evidence to support the use of ozone in oral and maxillofacial surgery. Ozone therapy has a therapeutic effect that promotes blood and growth factor supply, aids in wound healing, and may improve bone regeneration . However up till now, no studies were conducted to assess the impact of using ozone gel on bone formation in case maxillary sinus elevation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
biostatistician
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
- •Patient age should be > 18 years of age.
- •Patients included were ASA I and ASA II.
- •Both males and females were included in the study.
- •Patients with need of tooth replacements in the maxillary premolar and molar area where the residual alveolar bone height ranges from 4-7 mm and bone density D3 or D
- •Compliance with all requirements in the study and signing the informed consent.
排除标准
- •Patients with immunological diseases or diseases affecting bone healing.
- •Patients suffering from uncontrolled systemic diseases.
- •Patients with active acute infection related to the planned implant site, maxillary sinusitis or pathosis.
- •Patients with parafunctional occlusal habits.
- •Patients with bad oral hygiene.
- •Patients who were alcohol and drug abusers.
- •Heavy Smoker Patients.
- •Patients who went previous sinus lifting surgery.
研究组 & 干预措施
closed sinus lifting using osteotomes with simultaneous implant placement
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .
干预措施: closed sinus lifting using osteotomes with simultaneous implant placement (Procedure)
closed sinus lifting using osteotomes with simultaneous implant placement with ozone gel placement
Full thickness mucoperiosteal flap was elevated.• The pilot drill of the implant system was used to create an osteotomy 1 mm short of the subantral floor. • The insertion of the osteotome were repeated several times until the required membrane lift was achieved then the osteotome corresponding in size to the last drill was used.Ozone gel was delivered into the osteotomy . To obtain the ozone gel, pure olive oil was blasted with 25 μ/ml O3 gas for two days, or until the oil changed from a greenish-colored liquid to a whitish gel. The longevity Ext 120 ozone generator executed out this process. After that, placement of the implant was done .Healing abutment was placed to allow for multiple times measurements of implant stability and primary closure was done and the flap was sutured in an interrupted manner using 4/0 prolene suture .
干预措施: Ozone gel placed after closed sinus lifting then implant placed simultaneously. (Drug)
结局指标
主要结局
Implant stability
时间窗: Immediate postoperative,3 months and 4 months postoperative
- Resonance frequency analysis was performed to assess implant stability. The implant stability was measured using the Osstell ISQ scale "immediate postoperative then after 3 and 4 months . The readings were taken along the three surfaces of the implant (perpendicular to the implant axis, mesial surface and distal surface). Finally, the averages of these readings were taken as a representative value for each implant .
次要结局
- Bone Density(Immediate postoperative and 4 months postoperative)
- Bone height gain(Immediate postoperative and 4 months postoperative)
研究者
Dina yousry
Principle investigator "Doctorate candidate"
Suez Canal University