DRKS00009394已完成未知
Evaluation of peri-implant mucositis at microgrooved and machined abutments: A two-center study - CONELOG-LLT
Poliklinik für Zahnärztliche Chirurgie und Aufnahme, Universitätsklinikum Düsseldorf0 个研究点目标入组 28 人开始时间: 2015年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Subjects must have voluntarily signed the informed consent form before any study related action
- •2.Males and females between 18 and 65 years of age
- •3.Non-smokers
- •4.Edentulous or partially edentulous in posterior maxilla or mandible (#4-#7 FDI) with 1 implant planned (maximum 2 non adjacent implants).
- •5.Full mouth plaque (FMPS) must be = 15% at time of surgery
- •6.Full mouth bleeding score (FMBS) must be = 15% at time of surgery
- •7.Adequate bone quality and quantity at the implant site to permit the insertion of a titanium implants of >4.0 mm diameter
- •8.Vertical Soft tissue Dimenson =2 mm around the implant position
- •9.Width of keratinised tissue = 2mm around experimental implants
排除标准
- •Pre-surgical exclusion criteria
- •1.Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- •2.Any contraindications for oral surgical procedures
- •3.Mucosal diseases (e.g. erosive lichen planus)
- •4.History of local irradiation therapy
- •5.Current untreated periodontitis or gingivitis
- •6.Any untreated endodontic lesion
- •7.PPD of = 4 mm on one of the teeth immediately adjacent to the dental implant site
- •8.Keratinized gingiva < 2 mm or thin biotype
- •9.Severe bruxing or clenching habits
- •10.Patients with inadequate oral hygiene or unmotivated for adequate home care
- •11.Patients who smoke or chew tobacco
- •12.Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
- •13.Conditions 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 or unreliability
- •14.Use of systemic antibiotics in the past 3 months
- •15.Use of systemic antibiotics for endocarditis prophylaxis
- •16.Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- •17.Pregnant or breastfeeding women
- •Secondary Exclusion Criteria at Implant Surgery
- •1.Lack of primary stability of the implant
- •2.Simultaneous augmentation procedures
- •Secondary Exclusion Criteria at end of healing phase
- •1.Full mouth plaque score must be = 15% at the end of healing phase
- •2.Full mouth bleeding score must be = 15% at the end of healing phase
- •3.Mobility or infection
研究者
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