Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Bone Regeneration_Reduction in radiolucent volume
研究概览
简要总结
The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.
详细描述
With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be of legal age.
- •Participants must provide informed consent for participation in the study.
- •Participants must require extraction of both impacted mandibular third molars.
- •Both impacted molars must exhibit a similar level of complexity for extraction.
- •Participants must have no history of infection in the impacted molars prior to extraction.
- •Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).
排除标准
- •Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
- •Participants currently receiving medications contraindicated for dental extractions.
- •Participants under the age of legal consent.
- •Participants who have undergone head and neck radiotherapy within the past 18 months.
研究组 & 干预措施
Galibone Group
The Galibone+ experimental group includes participants receiving Galibone+ after impacted mandibular third molar extraction, testing its osteogenic properties. Galibone+ is prepared per manufacturer's instructions, potentially by immersing in sterile saline. Applied post-extraction into the socket using specialized instruments, it's compared to a control group receiving Bio-Oss, a standard xenograft material. Experimental group patients receive postoperative medications, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Goal: Assess Galibone+'s efficacy in bone regeneration versus control.
干预措施: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin (Combination Product)
Control group
The control group serves as an active comparator to the Galibone+ experimental group in this study. Participants undergo identical impacted mandibular third molar extraction procedures as the experimental group but receive a standard material, likely Bio-Oss, instead of Galibone+.
Bio-Oss, a widely used xenograft material in dental surgeries, acts as a benchmark due to its osteoconductive properties. Applied post-extraction into the socket with specialized instruments, it provides a reference for comparing Galibone+'s efficacy. Patients in the control group receive postoperative medications as per the study protocol, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation.
干预措施: Bovine Hydroxyapatite (Other)
结局指标
主要结局
Bone Regeneration_Reduction in radiolucent volume
时间窗: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration.
Bone Regeneration_bone volume
时间窗: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration.
Bone Regeneration_bone density
时间窗: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.
Bone Regeneration_Fractal dimension
时间窗: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface).
次要结局
- Pain levels through visual analog scale(24 hours, 48 hours, 72 hours, and 7 days)
- Clinical Inflammation evaluating by presence/absence(24 hours, 48 hours, 72 hours, and 7 days)
- Post-surgical complications evaluated by presence or absense(24 hours, 48 hours, 72 hours, and 7 days)
- Oral Health-related Quality of Life measured by OHIP-14 test(24 hours, 48 hours, 72 hours, and 7 days)
- Healing measured by healing index(24 hours, 48 hours, 72 hours, and 7 days)
研究者
Mario Pérez Sayáns
Principal investigator of ORALRES Group
University of Santiago de Compostela