Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Peri-implant bone level changes
研究概览
简要总结
This study designed as a randomized controlled split-mouth trial will be conducted at the Dental Clinic of the University of Valencia. The aim will be to assess differences in clinical, radiological and microbiological outcomes between implants with 2 different connections: internal hexagon and conical connection. Following the premises, to minimize the bias related to prosthetic phase and maximize the effect of connections on MBL changes, a 1abutment-1time protocol will be used.
The study hypothesis is that there will be no statistically significant differences between both implant connections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to sign an informed consent form
- •aged 25 years or more
- •Any patient requiring two implant-supported crowns in the lower or upper jaw
- •Kennedy class I, II, and III;
- •teeth extracted at least 6 months before implant placement;
- •sufficient bone volumes to accommodate dental implants without augmentation procedure
排除标准
- •General medical and/or psychiatric contraindications to implant surgery,
- •Pregnancy or nursing,
- •Heavy smoking (more than 10 cigarettes/day),
- •Treatment with anticoagulant drugs (International Normalized Ratio under 1.8), bisphosphonates, steroid therapy or anticonvulsants drugs.
- •No regenerated bone
- •Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
- •Patients with history of alcohol, narcotics or drug abuse. (Alcoholism: more than two bottles of beer per day)
- •Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment, or who have been administered radiotherapy in the last 5 years. (Patients through at any time received radiotherapy to the head and neck region should be excluded anyway.)
- •Metabolic bone disorders
- •Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
- •Degenerative diseases.
- •Osteoradionecrosis.
- •Renal failure.
- •Organ transplant recipients.
- •HIV positive.
- •Malignant diseases.
- •Diseases that compromise the immune system.
- •Unbalanced diabetes mellitus. (HbA1c above 6.5), Uncontrolled endocrine diseases
- •Psychotic diseases.
- •Hypersensitivity to one of the components of the implant in general and titanium in particular.
- •Women who are pregnant or lactating.
- •Lack of patient cooperation.
- •Parafunctional habits, such as Bruxism or Temporomandibular joint disease.
- •Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus, malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
研究组 & 干预措施
Internal hexagon connection
Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period.
Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection.
The Internal Hex (IH) implant has a 2.5mm internal hexagon and a 90° cone. The platform diameter is Ø3.5mm.
干预措施: Rehabilitation with dental implant with internal hexagon connection (Device)
Conical connection
Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period.
Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection.
The Conical Standard (CS) implant has a 2.5mm internal hexagon and 22° cone. The platform diameter is Ø3.1mm.
干预措施: Rehabilitation with dental implant with conical connection (Device)
结局指标
主要结局
Peri-implant bone level changes
时间窗: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
calculated using intraoral digital periapical radiographs
次要结局
- Prosthetic complications(3 years)
- Plaque(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)
- Resonance frequency analysis values(a. implant placement (baseline) b. abutment connection (8-12 weeks))
- Probing pocket depth(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)
- Implant failure(3 years)
- Microbial loads(12 months after loading)
- Bleeding on probing(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)
研究者
David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
University of Valencia