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
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 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.
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)
- Healing measured by healing index(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)
研究者
Mario Pérez Sayáns
Principal investigator of ORALRES Group
University of Santiago de Compostela