Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Change in marginal peri-implant bone loss of dental implants
研究概览
简要总结
Until now it has not been investigated whether placement of implants in SS patients is less successful than compared to non-SS patients. The risk factors and the efficacy of dental implants in dry mouth patients are not known because of the lack of scientific evidence. The aim of this study is to investigate changes in marginal peri-implant bone loss and the clinical performance of dental implants in SS patients compared to implants in healthy patients.
详细描述
Rationale: Until now it has not been investigated whether placement of implants in SS patients is less successful than compared to non-SS patients. The risk factors and the efficacy of dental implants in dry mouth patients are not known because of the lack of scientific evidence.
Objective: to investigate changes in marginal peri-implant bone loss and the clinical performance of dental implants in SS patients compared to implants in healthy patients.
Study design: A prospective multicenter clinical trial.
Study population: N = 120
Intervention: All patients receive Biohorizons Laser-lok bonelevel implants to replace the missing (pre)molars or to support a full denture in the upper and lower jaw .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(dentate group, Sjögren):
- •The patient is at least 18 years and younger than 70;
- •A diagnosed (by the AECG guidelines; see attachment; Vitali et al., 2002) 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. If necessary the autologue bone can be mixed with artificial bone (artificial 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 70;
- •A diagnosed (by the AECG guidelines; Vitali et al., 2002) 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 (lower or/and upper jaw).
- •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 will be performed with autologue bone. If necessary the autologue bone can be mixed with artificial bone (artificial 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.
研究组 & 干预措施
Dentate Sjogren's syndrome arm
30 human adults affected by SS with the need of replacement of missing premolars or molars in the upper or lower jaw. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
干预措施: Biohorizons Laser-lok bonelevel dental implants (Device)
Dentate healthy controls arm
30 healthy human adults with the need of replacement of missing premolars or molars in the upper or lower jaw. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
干预措施: Biohorizons Laser-lok bonelevel dental implants (Device)
Edentulous Sjogren's syndrome arm
30 human edentulous adults affected by SS with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
干预措施: Biohorizons Laser-lok bonelevel dental implants (Device)
Edentulous healthy controls arm
30 healthy human edentulous adults with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
干预措施: Biohorizons Laser-lok bonelevel dental implants (Device)
结局指标
主要结局
Change in marginal peri-implant bone loss of dental implants
时间窗: 1.5 years
changes in marginal peri-implant bone loss of dental implants between the healthy and SS groups and differences in clinical performance 1.5 years after finalization.
次要结局
- Width of keratinized epithelium(1.5 years)
- Patient satisfaction and impact of oral health on the quality of life(1.5 years)
- Denture function and satisfaction(1.5 years)
- Implant survival(1.5 years)
- Overdenture/crown survival(1.5 years)
- Modified Plaque-index and Modified Bleeding-Index(1.5 years)
- Probing depth(1.5 years)
- Disease symptoms (SS groups only)(1.5 years)
研究者
Derk Jan Jager
PhD
Amsterdam UMC, location VUmc