A Randomized Controlled Clinical Trial Comparing the Placement of an Oval Abutment in 2.9 mm Implants Versus a Circular Abutment in Implants of 3.3 mm to 12 Months of Evolution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The main objective was the papillary index (PI) (Jemt, 1997)
研究概览
简要总结
Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors.
Material and methods: fourty patients received unitary implants of 3.3mm or 2.9 mm diameter to replace the absence of upper lateral incisor or lower central/lateral incisor with an edentulous space of at least 6.4mm (mesio-distally). Esthetic and clinical parameters were evaluated 12 months after installation of the prosthesis.
Condition or disease: dental implants
Intervention/treatment: 3.3 or 2.9 mm diameter dental implants
Phase: Not Applicable
详细描述
The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth.
The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).
The main objective was the papillary index (PI) (Jemt, 1997). It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
The secondary objectives are (a) to observe the stability of the soft and hard tissues after one year in function, (b) to assess the success and survival rate of the implants, (c) to assess the stability of the implants and their evolution and (d) to analyze the degree of patient satisfaction with the aesthetic result.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The clinical monitor will hide the treatment to the clinical observer, the patient and the statistician.
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
- •Patients >18 years of age
- •Absence of upper lateral incisors or lower central / lateral incisors with an edentulous space of at least 6.4mm (mesio-distally).
- •The teeth adjacent to the edentulous space must be natural.
- •Patients who are in periodontal health.
- •Signing of informed consent before entering the study.
排除标准
- •Patients with any systemic condition or disease that may interfere with oral surgery.
- •History of radiotherapy.
- •Patients smoking more than 20 cigarettes per day.
- •Pregnant or breastfeeding patients.
结局指标
主要结局
The main objective was the papillary index (PI) (Jemt, 1997)
时间窗: 12 months
It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.
次要结局
- Assessment of the success of the implants(12 months)
- To observe the stability of the soft and hard tissues after one year in function: probing depth(12 months)
- To observe the stability of the soft and hard tissues after one year in function: suppuration on probing(12 months)
- To observe the stability of the soft and hard tissues after one year in function:bleeding on probing(12 months)
- To observe the stability of the soft and hard tissues after one year in function: Modified plaque index (MPI)(12 months)
- Assessment of survival rate of the implants(12 months)
- Analyze the degree of patient satisfaction with the aesthetic result.(12 months)
研究者
Ana María García de la Fuente
Professor
University of the Basque Country (UPV/EHU)