Clinical Comparison of On1 Two-stage Abutment With One-stage Abutment on Different Implant Neck Design
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The degree of bone resorption at the shoulder edge of the implant
研究概览
简要总结
In clinical implant treatment, the healing abutment or temporary abutment needs to be removed or replaced multiple times after implant insertion and before prosthesis restoration. During this process, the friction between connective tissue around the implant cannot be avoided. Different from natural periodontal tissue, soft tissue around the implant lacks the periodontal ligament barrier and periodontal ligament blood supply, and is more likely to be damaged during repeated wearing. The integrity, health and stability of the peri-implant connective tissue is crucial to the implant osseointegratio. Through randomized controlled trials and meta-analysis, Marco Tallarico et al found that repeated removal of one-stage abutments can significantly increase bone resorption.
Based on this situation, the design of implant neck and abutment, especially the design concept of smooth collar, has attracted widespread attention. The design of smooth collars with different heights can isolate the mechanical damage of the abutment to the connective tissue around the implant to different degrees. Among them, the On1 two-stage abutment has a smooth collar with a height of 1.75-2.5mm, and the Nobel implants have a smooth neck design ranging from 0-0.75mm to protect the connective tissue around the implant. Through a systematic review and meta-analysis, Qing-qing Wang et al concludes that direct mechanical stimulation from the abutment has long-term adverse effects on peri-implant connective tissue and bone tissue. However, whether the On1 two-stage abutment has a positive effect on the stabilization of the peri-implant soft tissue and bone tissue remains to be studied.
At the same time, the relative height of the smooth collar increased by the On1 abutment in the implants with different neck designs varies to some extent, and further research is still needed to provide evidence about the effect of the On1 abutment on the tissue surrounding the implants with different neck designs. In conclusion, this study took On1 two-stage abutment and traditional one-stage abutment as the research objects to compare and evaluate the clinical effects of the two in different implant neck design.
详细描述
Research purpose To compare the clinical effects of On1 two-stage abutment and one-stage abutment in implants with different neck design.
Research Design and Methods
- Type of study design: prospective intervention single-center randomized clinical trial
- Study period: 7 years
- Start time: from the date of ethics approval, end time: March 2029
- This study takes a single-blind method. During research process, the researchers cannot avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded.
Measures to control bias:
- Selection bias control: use the random number table method for grouping, and strictly follow the blinding method. During the recruiting period, the researcher needs to fully know the subjects and improve the understanding and compliance of the test; during the recruiting period, at least 2 contact information should be left. In emergencies, the subjects themselves can be contacted to minimize the rate of loss to follow-up; for those fail to follow-up, data will be excluded in the follow-up statistical phase;
- Control of information bias: 1) rigorously design case report forms, 2) set up two 3) Collect data on objective indicators as much as possible, conduct regular researcher training, and unify evaluation standards;
- Control confounding bias: improve the study design, control single variable grouping, and adopt reasonable statistical analysis methods.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study takes a single-blind method. During research process, the researchers cannot avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded.The clinical examination data were measured and averaged by two independent clinicians. The data was analysed by a third person.
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
- 否
入选标准
- •(1) aged 18 years and above, 70 years old and below; (2) Single crown restoration after implantation (3) Subjects signed written informed consent; (4) The general health status is good and adhered to Good oral hygiene conditions; (5) no infection and extraction residues at the implant site; (6) sufficient keratinized gingiva on the cheek and tongue; (7) good and stable occlusal relationship; (8) the occlusal gap is higher than 4mm; (9) No other additional operations are planned to perform.
排除标准
- •(1) contraindications to general implant surgery; (2) uncontrolled diabetes mellitus; (3) any signs of immunosuppression; (4) previous head and neck radiation therapy; (5) past or current use of bisphosphonates treatment; (6) substance abuse; (7) nocturnal teeth grinding; (8) signs of periodontitis; (9) smoking more than 10 cigarettes per day; (10) poor oral hygiene; (11) mental disorders; (12) inability to complete follow-up; (13) History of night grinding.
结局指标
主要结局
The degree of bone resorption at the shoulder edge of the implant
时间窗: 1-7 years
1. Thickness of the buccal bone plate 0 mm below the implant abutment (W1): Select the mid-axis of the implant in the sagittal plane.The thickness of the lateral buccal plate (W1) is determined by selecting the mid-axis of the implant in the sagittal plane and making a straight line perpendicular to the long axis of the implant to the buccal side of the implant table. 2. Thickness of the buccal bone plate 2、4、6 mm below the implant abutment (W2、W3、W4): select the sagittal implant centre axis and make a straight line perpendicular to the long axis of the implant, starting from the buccal bone plate.(W2、W3、W4): Choose the mid-axis of the implant in the sagittal plane and start from the buccal bone plate and make a straight line perpendicular to the long axis of the implant to the distance from the buccal side of the implant 2、4、6 mm below the shoulder table.
The distance between the level of implant shoulder and the alveolar ridge.
时间窗: 1-7 years
The distance between the level of implant shoulder and the alveolar ridge.
次要结局
- abutment buccal keratinized gingiva width(1-7 years)
- probing bleeding index(1-7 years)
- mesial and distal gingival papilla and buccal mucosa recession(1-7 years)
- buccal bone wall thickness at 0/2/4/6 mm below the implant shoulder(1-7 years)
- time to subsidence of mucous membrane blushing when wearing teeth(within 30 minutes)
- Patients' self-satisfaction visual analogue scale score(within 30 minutes)
研究者
Yi Zhou
Deputy Chief Physician, Deputy Director of Dental Implant Department
The Dental Hospital of Zhejiang University School of Medicine