The Esthetic Effect of Bio-OSS Collagen® on the Mid-facial Gingival Dimensions When Placed Into Gaps Between 3i® Implants Placed Into Fresh Extraction Sockets and the Labial Plate of Bone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Bucco-Lingual Change at 3mm
研究概览
简要总结
This study compares two ways of placing a dental implant on the day of tooth extraction. One method will place a additional bone graft (derived from bovine bone) and the other group will not have the graft placed. Both groups will be restored at the same time with an immediate crown.
The investigators will be researching and comparing the changes in gum level that occur after each surgical method, as well as changes in jaw width where the implant is placed.
The investigators will enroll 16 patients per group. The patients will be followed for 3, 6, and 12 months post-immediate implant placement to observe healing.
详细描述
The purpose of the current study is to evaluate the soft tissue dimensional changes after extraction of teeth in the esthetic zone, when combined with the placement of implants into these fresh extraction sockets. In addition, the effect of placing a graft material, such as Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated after an immediately loaded provisional restoration is placed. 32 subjects will have an immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test group) and 16 subjects will have no graft (Control group) in the gap between the implant and the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants will be placed in a flapless procedure. Implants will be immediately loaded with provisional restorations once determined that the implant is stable. Changes in vertical height and horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12 months post-immediate implant placement.
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
- •Subject must have read, understood and signed an informed consent form.
- •Subjects must be willing and able to follow study procedures and instructions.
- •Subjects must have labial plate of bone present after extraction no more than 4 mm from the free gingival margin.
- •Subjects must require one maxillary anterior implant.
- •Subjects must be older than 18 years
排除标准
- •Subjects having participated within the last six months in other clinical studies.
- •Subjects who have failed to maintain good plaque control.
- •Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, human immunodeficiency virus (HIV), disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery.
- •Subjects with the presence of acute infectious lesions in the areas intended for surgery.
- •History within the last 6 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day).
- •Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study.
- •Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100
- •Subjects requiring antibiotic prophylaxis for subacute bacterial endocarditis (SBE) or late prosthetic joint infection. Patients who cannot undergo standard oral surgery procedure for any reason.
- •Subjects that have adjacent teeth next to tooth slated for extraction and immediate placement showing periodontal disease, endodontic and/or caries pathology will be excluded.
- •Subjects having unfavorable occlusal schemes for immediate loading, parafunctional habits and inadequate posterior support to properly protect the anterior teeth during function.
- •Implant site will not be next to an adjacent implant.
研究组 & 干预措施
BioOss Collagen
Intervention: BioOss Collagen at the time of implant placement
干预措施: BioOss Collagen at the time of implant placement (Device)
No Bone Graft
No placement of BioOss at the time of implant placement
结局指标
主要结局
Mean Bucco-Lingual Change at 3mm
时间窗: Baseline and 12 months
The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.
Mean Bucco-Lingual Change at 4mm
时间窗: Baseline and 12 months
The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.
次要结局
- Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)(Baseline and 12 months)
- Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)(Baseline and 12 months)
- Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)(Baseline and 12 months)
- Thickness of Keratinized Tissue at 4mm(12 months)
- Thickness of Keratinized Tissue at 8mm(12 months)
- Periodontal Probing Depth(12 months)
- Thickness of Keratinized Tissue at 3mm(12 months)
研究者
Nurit Bittner Fogel
Assistant Professor of Dental Medicine
Columbia University