A Controlled Clinical Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Sulcus Bleeding Index (According to Mombelli et al 1987)
研究概览
简要总结
This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).
详细描述
This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject.
The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have voluntarily signed the informed consent form before any study related action
- •Males and females must be at least 18 years of age and not more than 80 years old.
- •Partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket.
- •Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann Soft Tissue Level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal)
排除标准
- •Oral surgery contraindicated according to the judgement of the investigator (should be explained in the CRF)
- •Local inflammation, including untreated periodontitis
- •Patients with inadequate oral hygiene or unmotivated for adequate home care. Full mouth plaque index > 25% at time of surgery
- •Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
- •Major systemic diseases
- •Medical conditions requiring prolonged use of steroids
- •Current pregnancy or breastfeeding women
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene
- •Use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0
- •Alcoholism or chronically drug abuse
- •Smokers; more than 10 cigarettes per day
- •Immuno-compromised patients
- •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.
- •Secondary Exclusion Criteria:
- •GBR procedures at or adjacent to the planned study site
- •Lack of primary stability of the dental implant at site of interest (e.g., rotational movement of the implant at a minimum of 15 Ncm torque at connection of the healing abutment, or tactile mobility)
研究组 & 干预措施
Standard Plus ESTA STL Roxolid implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
干预措施: Standard Plus ESTA STL Roxolid implant (Device)
Standard Plus STL implant
This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
干预措施: Standard Plus STL implant (Device)
结局指标
主要结局
Sulcus Bleeding Index (According to Mombelli et al 1987)
时间窗: 12 months
The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
次要结局
- Soft Tissue Healing Evaluation(10 days and 12 weeks)
- Dental Implant Success and Implant Loss(3 years)
- Sulcus Bleeding Index (According to Mombelli et al 1987)(3 years)
- Recession of Gingival Margin Buccally and Lingually/Palatal(1 and 3 years)
- Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements(1 and 3 years)
- Oral Hygiene(Screening, 6, 12, 36 months)
- Probing Pocket Depth (PPD)(6 months, 1 and 3 years)
- Adverse Events(up to 3 years)
- Clinical Attachment Level (CAL)(6 months, 1 and 3 years)