Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
研究概览
简要总结
The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.
详细描述
This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.
Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.
A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.
The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.
The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age: between 20 and 65
- •No systematic contraindication for implant surgery
- •No more than 10 cigarettes/day
- •Previous horizontal bone augmentation 6 months prior to implant placement
- •Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)
排除标准
- •Smokers more than 10 cigarettes/day
- •Pregnant/lactating women
- •Alcoholics/drug addicts
- •Uncontrolled diabetics, immunocompromised, blood hemostasis problems
- •Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
- •Patients not willing to sign the consent form
- •History of radiotherapy in the head and neck region in the last 5 years
- •Active periodontitis on the remaining teeth
研究组 & 干预措施
Internal hex implant
Internal implant connection
干预措施: Implant insertion (Device)
External hex implant
External hexagone implant connection
干预措施: Implant insertion (Device)
结局指标
主要结局
Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
时间窗: During procedure, at 4 months, at 6 months and 1 year
Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
Change from baseline of alveolar ridge thickness at 4 months
时间窗: During procedure and at 4 months
Peroperative surgical measurements of the alveolar ridge width at implant sites
Change from baseline of radiographic bone level on CBCT at 1 year post-op
时间窗: During procedure and at 1 year
CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
Change from baseline of bone plate thickness at 4 months
时间窗: During procedure and at 4 months
Peroperative buccal and lingual residual bone thickness following implant insertion
次要结局
- Insertion torque(During procedure)
- Change of FMBS parameters from baseline to 1 year post-op(During procedure, at 6 months and at 1 year)
- Histological analysis(During procedure)
- Change of Clinical parameters from baseline to 1 year post-op(During procedure, at 6 months and at 1 year)
- Change of Keratinized tissue height from Baseline to 4 months(During procedure and at 4 months)
- Change of FMPS parameters from baseline to 1 year post-op(During procedure, at 6 months and at 1 year)
研究者
Nada BOU ABBOUD NAAMAN
Full Professor
Saint-Joseph University