Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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 general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.
详细描述
The proposed protocol is a multicenter clinical trial aimed at analyzing the osteogenic action of a medical device based on beta-tricalcium phosphate (hereinafter BTCP) in the bone regeneration process following the extraction of impacted mandibular third molars. The specific objectives of the study include a comparative analysis of clinical and radiological variables between a control group and a study group.
Inclusion criteria for study subjects include being of legal age, providing informed consent, and requiring the extraction of both impacted mandibular third molars, among others. Exclusion criteria include the presence of severe mental disorders or medical contraindications for tooth extraction.
The study involves a total of 60 third molars from 30 patients, divided into a control group and a study group. Data will be collected regarding patient demographics, the surgical procedure, and the bone regeneration assessment.
The surgical procedure involves selecting patients with similarly complex third molars, followed by tooth extraction and the placement of BTCP in the study group or a standard material in the control group. Clinical follow-up will be conducted during the first 7 days, and radiological follow-up will take place over the following 6 months to evaluate bone regeneration.
Patients will receive compensation for their participation in the study, which includes medical consultations, phone follow-ups, examination time, completion of questionnaires, and training in self-assessment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be of legal age, generally defined as 18 years or older, to be able to provide adequate informed consent and understand the risks and benefits of the procedure.
- •Informed Consent: Patients must be willing to provide written informed consent to participate in the study, indicating their understanding and acceptance of the associated procedures and risks.
- •Need for Extraction of Impacted Mandibular Third Molars: Patients must require the extraction of both impacted mandibular third molars to be eligible for the study.
- •Similar Complexity of Impacted Third Molars: The impacted mandibular third molars must present similar complexity for extraction on both sides of the jaw, to ensure a fair comparison between the study groups.
- •Absence of Medical Contraindications for Oral Surgical Procedures: Patients must not have significant medical contraindications that would prevent oral surgical procedures, such as clotting disorders, uncontrolled systemic diseases, or a history of severe infections.
排除标准
- •Severe Mental Disorders: Patients with severe mental disorders that may affect their ability to understand and follow study instructions may be excluded due to concerns about their capacity to provide valid informed consent and follow the study protocol.
- •Contraindications for Dental Extractions: Patients with specific contraindications for dental extraction, such as a history of osteonecrosis of the jaws or serious complications associated with previous dental procedures, may be excluded for safety reasons.
- •Patients under the age of 18 will not be eligible to participate in the study due to ethical and legal concerns related to obtaining informed consent and the ability to understand the risks and benefits of the study.
- •Withdrawal from the Study:
- •If a patient experiences severe complications during the study, such as severe postoperative infections, severe allergic reactions, or any other adverse event that may jeopardize their health, they will be considered for withdrawal from the study to ensure their well-being. Additionally, if a patient decides to voluntarily withdraw from the study at any time, their decision will be respected, and appropriate medical care will be provided as needed.
研究组 & 干预措施
BTCP Group
The experimental BTCP group includes participants who will receive BTCP after the extraction of an impacted mandibular third molar to test its osteogenic properties. BTCP is prepared according to the manufacturer's instructions, initially by immersing it in sterile saline solution. It is applied to the socket after extraction using specialized instruments and is compared with a control group that receives Bio-Oss, a standard xenograft material.
Patients in the experimental group receive postoperative medication, including antibiotics and pain management treatment. Follow-up evaluations assess pain, inflammation, complications, and bone regeneration through radiological assessment.
Objective: To evaluate the efficacy of BTCP in bone regeneration compared to the control.
干预措施: Medical device: beta-tricalcium phosphate (Combination Product)
Control group
The control group serves as the active comparator to the BTCP experimental group in this study. Participants undergo the same impacted mandibular third molar extraction procedures as those in the experimental group, but receive a standard material, Bio-Oss, instead of BTCP.
Bio-Oss, a widely used xenograft material in dental surgeries, serves as the reference due to its osteoconductive properties. It is applied to the socket after extraction using specialized instruments and acts as a benchmark for comparing the efficacy of BTCP. Patients in the control group receive postoperative medication according to the study protocol, including antibiotics and pain management treatment. Follow-up assessments evaluate pain, inflammation, complications, and bone regeneration through 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)
- Healing measured by healing index(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
Professor
University of Santiago de Compostela