Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration Without GBR in Comparison to a Conventional Neck Design With GBR-procedure: A Prospective Randomized Clinical Trial
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
- 1
- 主要终点
- marginal bone level
研究概览
简要总结
This study is a controlled, randomized clinical trial over about 16-months (active phase). 40 patients in need of replacement of a single tooth with a minimal crestal bone width of 4 - 5mm and suitable for simultaneous GBR (Guided Bone Regeneration) procedure as well as at least a neighboring tooth on its mesial aspect will be consecutively recruited at the Department of Dental Medicine and Oral Health Graz. Volunteers will be screened and eligible subjects will be randomized to two different groups. In group 1 implants with regular neck design (Astra Tech Implant EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) and GBR procedure (BioOss® and BioGide®, Geistlich, Wolhusen, Schweiz) fixed with two membrane pins (Hipp Medical AG, Kolbingen, Germany) will be used; in group 2 implants with sloped marginal configuration (Astra Tech Implant Profile EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) without bone augmentation are used. The dimension of the bony defect and amount of lingual-buccal bone height discrepancy (max. 5mm) respectively bone width will be evaluated using a 3-D volume tomography (Planmeca ProMax® 3D Max, Planmeca, Helsinki, Finland), which is needed for digital planning (Simplant Planning Software, Leuven, Belgium) of the implant position, length and diameter as well.
详细描述
Digital scans will be done at first, 5th, 6th, 8th, and 10th visit to get the possibility to determine and compare volume changing and stability at augmented or not augmented implant sites during follow up visits.
According to standard procedure, patients will receive an antibiotic regime (Augmentin 1g, 2x1, GlaxoSmithKline, Vienna, Austria; in case of penicillin-allergy: DalacinC 300mg, 3x1, Pfizer, Vienna, Austria) starting one day prior surgery till 3 days after surgery. Before implant surgery patients are advised to rinse with a local antiseptic chlorhexidine gluconate solution (Chlorhexamed forte 2mg/ml, GlaxoSmithKline, Vienna, Austria). Articain is used for local anesthesia (Ultracain D-S forte with epinephrine 1:100.000, Sanofi Aventis, Vienna, Austria). These drugs are not object of the investigation. After flap elevation the lingual-buccal height discrepancy and bone width is measured using a periodontal probe. The implant surgery is done following the standard surgical protocol of implant placement of the Department of Dental medicine and Oral Health Graz using a pilot drill guide. After implant insertion the marginal bone level will be measured using a periodontal probe. Implant shoulder attends as a reference.
After implant insertion (Astra Tech Implant EV C or Astra Tech Implant Profile EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany), GBR (Astra Tech Implant EV C) and a healing period of approximately 3 months for both groups, the implants will be uncovered following the standard protocol of the Department of Dental medicine and Oral Health Graz, and titanium gingiva formers will be placed (non-investigational devices). After implant recovery the marginal bone level will be measured again using a periodontal probe. Implant shoulder attends as a reference.
All patients will receive CE-certified gingiva formers, which are used in the Department of Dental Medicine and Oral Health Graz and which are approved in Austria. 1 week after reentry the sutures will be removed and the digital impression (PrimeScan) for the CAD/CAM (Computer Aided Design /Computer Aided Manufacturing) manufactured single implant crowns using customized individual abutments (Atlantis, Mölndal, Sweden) will be done.
Radiographic examinations (single-tooth x-ray) will be done at implant recovery (3 months after implant placement, visit 6), visit 10 and visit 11.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written consent after clarification
- •capability of giving an informed consent
- •good health as defined by the subjects medical history (no contraindications as described in the
排除标准
- •age 18 years of age and over
- •Good periodontal status: BOP < 20%, PI < 30%, no PD > 4mm
- •No heavy smokers (< 10 cigarettes/day)
- •At least 1 missing tooth in the premolar and molar region (in selected cases in the frontal area) either in the maxilla or in the mandible requiring implant therapy for reconstruction.
- •implant site must present a buccal bone defect not extending a lingual-buccal or buccal-palatinal height discrepancy of 5mm and a sufficient bone width for simultaneously GBR procedure
- •implant site must present at least a neighbouring tooth on its mesial aspect
- •Exclusion Criteria:
- •Insufficient bone volume for implant placement requiring a sinus floor elevation or extensive bone augmentation
- •Heavy Smokers (>10 cigarettes/day)
- •Medication with a contraindication for implant therapy
- •Skeletal immaturity
- •Any active malignancy or ongoing treatment for malignancy
- •An active infection at the operative site
- •Contraindications to the class of drugs which are used at regular surgical procedures, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, except penicillin-allergy
- •Pregnancy
- •unable or unwilling to return for follow-up visits for a period of at least 16 months
研究组 & 干预措施
Astra Tech Implant System Profile EV
Implants with sloped marginal configuration without bone augmentation are used.
干预措施: Astra Tech Implant System Profile EV (Device)
Astra Tech Implant System EV
Implants with regular neck design and GBR procedure fixed with two membrane pins will be used.
干预措施: Astra Tech Implant System EV (Device)
结局指标
主要结局
marginal bone level
时间窗: 15 months
measured by single tooth X-ray
次要结局
- implant survival rate (ISR) in percent(15 months)
- clinical parameter: Bleeding on probing(15 months)
- clinical parameter: Plaque index(15 months)
- clinical parameter: Probing depth(15 months)
- clinical parameter: Papilla index(15 months)
- patient satisfaction(15 months)