A Randomised Clinical Trial Investigating Effect of Implant Surface Characteristic on Crestal Marginal Bone Loss, Inflammatory Response and Aesthetic Outcomes: Novel Gradient Anodized and Sandblasted Large-grit Acid-etched Implant Surfaces
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Coronal Facial Bone Maintenance
研究概览
简要总结
This study aims to characterise the stability of crestal bone levels one year after loading, the associated aesthetic outcomes, immunological response, prosthodontic outcomes as well as overall patient reported outcome measures for modSLA (SLActive, Institut Straumann AG, Switzerland) and NGA (TiUltraNP, Nobel Biocare AG, Switzerland) dental implants.
详细描述
Ultra-hydrophilic SLActive (modSLA) implants have been extensively studied in pre-clinical and clinical studies, demonstrating their pro-osteogenic nature and long-term maintenance of facial bone and aesthetics.
A novel multi-zone novel gradient anodized (NGA) hydrophilic surface (TiUltra) has recently been introduced to clinical practice. Pre-clinical studies have demonstrated that the smoother coronal aspect achieved stable soft tissue adhesion.
In clinical practice, prosthetically driven implant placement, particularly in the anterior maxilla, may result in a buccal dehiscence that is commonly treated with guided bone regeneration (GBR). Currently no studies have been published investigating differences between these commercially available implant surfaces (modSLA, NGA).
This prospective, single centre randomised clinical trial will recruit 39 patients who require a single tooth extraction in the anterior maxilla for a Type IIc implant placement.
Patients enrolled in the study will be allocated to one of three implant groups:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: over 18 years old,
- •Gender: male and female.
- •Patient must be able and willing to follow study procedures and instructions and have capacity to provide informed consent.
- •Patient must require tooth extraction of a maxillary first premolar or single-rooted anterior tooth as the result of caries, endodontic failure or trauma
- •The extraction site must have adjacent teeth present.
- •Adjacent teeth with no evidence of interdental bone loss
排除标准
- •Systemic disease that can interfere with dental implant therapy (e.g. uncontrolled diabetes)
- •2 adjacent teeth requiring extraction
- •Greater than one wall of the socket missing - assessed at time of extraction
- •Any contraindications for oral surgical procedures
- •Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation;
- •Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit;
- •HIV or viral hepatitis;
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
- •History of local irradiation therapy in the head-neck region
- •Mucosal diseases (e.g. erosive lichen planus)
- •Current untreated periodontitis or gingivitis. In particular probing depths of >4mm on one of the teeth immediately adjacent to the extraction site
- •Untreated acute endodontic lesions
- •Current smokers (have smoked within 3 months of study onset)
- •Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation;
- •Self-reported alcoholism or chronic drug abuse;
- •Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood,
- •Non-compliant patients, vulnerable individuals or those unable to understand written or verbal communication and give consent.
- •Pregnant or breastfeeding patients
- •Involvement in current research or recent involvement in any research prior to recruitment
- •Full-mouth bleeding (BOP) and plaque (PI) scores >30% or sites with periodontal pocket depth >5 mm at the completion of the pre-treatment phase.
研究组 & 干预措施
NGA Implant
NGA Implant (NobelActive TiUltraNP, Nobel Biocare AG, Switzerland)
干预措施: Implant Type (Device)
BLX implant (BLX) modSLA Surface
BLX implant (BLX) modSLA Surface (BLX, SLActive, Roxolid, Institut Straumann AG, Switzerland)
干预措施: Implant Type (Device)
TLX implant (TLX) modSLA Surface
TLX implant (TLX) modSLA Surface (TLX, SLActive, Roxolid, Institut Straumann AG, Switzerland).
干预措施: Implant Type (Device)
结局指标
主要结局
Coronal Facial Bone Maintenance
时间窗: 1 Year post loading
A numerical comparison of coronal facial bone thickness between the groups. CBCT scans will be compared to quantify the linear changes in crestal bone thickness at the coronal aspect of the implant (shoulder of NGA and BLX implants and rough-smooth transition of TLX implant).
次要结局
- Aesthetic Outcome(1 Year post loading)
- Immunological Response(Pre-surgery to 12 Weeks post surgery)
- Primary Stability(1 Year post loading)
- Patient Satisfaction(1 Year post loading)
- Patient Satisfaction- Aesthetics(1 Year post loading)