Validation and Clinical Assessment of Clinical and Radiological Classification of the Jawbone Anatomy in Endosseous Dental Implant Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of patients with proper clinical diagnosis based on classification
研究概览
简要总结
The purpose of this study is to evaluate validation and clinical assessment of the earlier proposed clinical and radiological classification of the jawbone anatomy in endosseous dental implant treatment.
Expected results.
- high accuracy of proposed classification for proper implantation risk degree evaluation.
- the proposed classification system based on anatomical and radiological jawbone quantity and quality evaluation will be a helpful tool for planning of treatment strategy and collaboration among specialists.
- good interobserver reliability of clinical and radiological edentulous jaw segment evaluation.
- good reliability between radiological and intraoperative investigations and postoperative data.
详细描述
The study aim.
to assess reliability and validity of the purposed jawbone anatomy clinical and radiological classification.
Objectives.
- risk degree evaluation for proper implantation.
- radiological edentulous jaw segment assessment according to study protocol for classification validation and reliability.
- intraoperative evaluation of surgery (dental implant placement if edentulous jaw segment (EJS) is type I or type II) according to study protocol: reliability of new proposed classification evaluation.
- postoperative radiological edentulous jaw segment evaluation for the accuracy of the classification identification.
- implant treatment success evaluation at final crown placement.
Object of the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •systematically healthy (American Society of Anaesthesiologists I or II)
- •subject age 18 years or older women and men
- •availability of complete clinical records
- •compliance with all requirements in the study and signing the informed consent
- •absence of allergy to dental implants alloys
- •subjects have one or more single limited by neighbouring teeth from both sides edentulous jaw segment
- •the tooth was lost two months or earlier prior the study
- •adjacent edentulous jaw segments have no implant
- •adjacent teeth are intact or have all no defective restorations over cementoenamel junction
- •patient will not wear any kind of removable prosthesis over the treatment area
排除标准
- •acute infection at the region of edentulous jaw segment
- •active periodontal diseases
- •current orthodontic or periodontal treatments
- •heavy smokers (more than 10 cigarettes a day)
- •untreated teeth or defective restorations that can potentially exacerbate during the study
- •wisdom tooth edentulous jaw segment or edentulous jaw segment with unerupted tooth
- •central and lateral lower incisors edentulous jaw segments (individual case related treatment planning)
- •pregnancy or lactating mothers
- •history of alcoholism or drug abuse
- •bone disorders (Paget's disease, osteoporosis, or hyperparathyroidism)
- •a history of intravenous (IV) bisphosphonate use
- •neurologic or psychiatric disorders, systemic infections
- •chronic use of medications known to affect the periodontal status (calcium antagonists, anticonvulsives, immunosuppressives, anti-inflammatory medications)
- •diseases of the immune system or any medical conditions that may influence the treatment outcome (e.g. uncontrolled diabetes)
研究组 & 干预措施
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Cone-Beam Computed Tomography preoperative evaluation. (Radiation)
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Intraoperative edentulous jaw segment parameters evaluation. (Procedure)
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Endosseous dental implant placement. (Device)
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Dental implant position evaluation. (Radiation)
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Medications. (Drug)
Classification assessment.
Random group of the partially edentulous individuals will be assessed according to prepared classification evaluation protocol during dental implant treatment period. Cone-beam computed tomography preoperative evaluation will be made during preoperative stage. Intraoperative edentulous jaw segment parameters evaluation, endosseous dental implant placement parameters assessment during intraoperative stage will be made. Dental implant position evaluation during early postoperative stage will be made. Medications will be prescribed. Late postoperative soft tissue evaluation of edentulous jaw segment will be made during final crown placement. Cone-beam computed tomography analysis results will be compared with subsequent stages assessment results to evaluate reliability of the classification.
干预措施: Late postoperative soft tissue evaluation. (Procedure)
结局指标
主要结局
Number of patients with proper clinical diagnosis based on classification
时间窗: One year
Number of patients with proper diagnosis represent reliability of the classification
次要结局
未报告次要终点
研究者
Marius Kubilius
DDS, Oral Surgeon, PhD Student
Lithuanian University of Health Sciences