NL-OMON44593已完成不适用
Implantology and Sjögren*s syndrome: a multicenter prospective cohort study - Implantology and Sjögren*s syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria (dentate group, Sjögren)
- •- The patient is at least 18 years and younger than 80;
- •- A diagnosed (by the AECG guidelines; see attachment) primary or secondary Syndrome of Sjögren;
- •- The missing or lost tooth/teeth are premolars and/or molars in the upper or lower jaw.
- •- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 3.8 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone mixed with artificial bone (tricalcium phosphate bone graft substitutes in combination with a membrane).
- •- The implant site must be free from infection;
- •- Adequate oral hygiene (modified plaque index and modified sulcus bleeding index * 1) (Mombelli et al., 1987; Loe and Silness, 1963)
- •- Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
- •- The patient is capable of understanding and giving informed consent.;Inclusion criteria (edentulous group, Sjögren)
- •- The patient is at least 18 years and younger than 80;
- •- A diagnosed (by the EULAR guidelines) primary or secondary Syndrome of Sjögren
- •- The patient is edentulous. Before final inclusion in the study the patient has to be edentulous for 1 year.
- •- Problems with conventional denture retention, stability and/or adaptation, which could be solved by an implant, supported denture.
- •- Sufficient healthy and vital bone to insert dental implants with a minimum length of 8 mm and at least 3.8 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure and/or sinus elevation procedure will be performed with autologue bone mixed with artificial bone (tricalcium phosphate bone graft substitutes in combination with a membrane).
- •- The implant site must be free from infection;
- •- Capable of performing adequate oral hygiene;
- •- The patient is capable of understanding and giving informed consent.;Inclusion criteria control groups
- •- The inclusion criteria for the healthy control groups are similar as for the Sjögren groups without the Sjögren criterion.
排除标准
- •Criteria used for excluding patients from this study are as follows:
- •- Medical and general contraindications for the surgical procedures;
- •- Presence of an active and uncontrolled periodontal disease as expressed by probing pockets depths > 4mm with bleeding upon probing;
- •- Smoking (patients who stop smoking six weeks before the operation can be included);
- •- A history of radiotherapy to the head and neck region.
- •- Use of intravenous bisphosphonates or the use of oral bisphosphonates for more than 5 years.
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