Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System: Open Ended Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Radiographic Bone Level (RBL) Change
研究概览
简要总结
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully edentulous maxilla
- •The implant site has to be healed for at least 4 months after extraction
- •Wearing complete dentures deemed adequate
- •Orthopantomogram available (OPT)
- •Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant
- •No bone grafting required
- •Implant IT ≥ 20 N/cm
排除标准
- •Conditions requiring chronic routine prophylactic use of antibiotics
- •Conditions requiring prolonged use of steroids
- •History of leukocyte dysfunction and deficiencies
- •Bleeding disorders
- •History of neoplastic disease requiring use of radiation or chemotherapy
- •Metabolic bone disorders
- •Uncontrolled endocrine disorder
- •Use of any investigational drug or device within the 30-day period prior to implant surgery
- •Smoking more than 10 cigarettes a day
- •Alcoholism or drug abuse
- •Patient infected with HIV
- •Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
- •Local exclusion criteria:
- •Local inflammation including untreated periodontitis
- •Mucosal disease such as erosive lichen planus
- •History of local irradiation therapy
- •Osseous lesion
- •Severe bruxism and clenching habits
- •Active infection with suppuration or fistula track
- •Persistent intraoral infection
- •Lack of primary stability <20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol.
- •Inadequate oral hygiene or unmotivated home care.
- •Bone grafting
- •Inadequate bone volume for implants insertion as measured on the per-treatment CBCT.
结局指标
主要结局
Radiographic Bone Level (RBL) Change
时间窗: Baseline to 12 months post implant
RBL change will be measured in mm on standardized periapical radiographs. The distance between the implant platform and the most coronal level of the bone deemed to be in contact with the implant surface will be evaluated. Mesial and distal bone height measurements will be averaged for each implant. The measurements of the bone level at implant placement will be considered as baseline. The RBL change will be calculated in comparison with the baseline value.
次要结局
未报告次要终点