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临床试验/NCT05330702
NCT05330702终止不适用

Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With or Without Soft Tissue Augmentation

University of Iowa1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
1
主要终点
Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting

研究概览

简要总结

Mid-facial recession following immediate implant placement (IIP) in the place of a tooth poses a significant challenge for clinicians to treat. Emerging evidence shows that connective tissue graft (CTG) augmentation may mitigate the remodeling of the buccal bone crest (i.e., bone within the gum that supports the tooth), and lessen the soft tissue recession. A recent systemic review suggested a supplemental CTG grafting to IIP as a standard of care, especially for cases that have a high esthetic risk, specifically with a thin gingival biotype (i.e., thin gum tissue) and a thin buccal bone plate. The alternative option to augment the facial contour is the xenogeneic volume-stable collagen matrix (VCMX), which favors avoiding morbidity but hasn't been thoroughly investigated on IIP. Despite that IIP has attracted considerable scientific interest, the dynamic changes of the bone crest and soft tissue, especially during the early healing stage (<3 months following IIP), are little known. Recently, an ultrasonography protocol has been validated for its diagnostic value in dental implant research. High-frequency B-mode imaging and color flow and power Doppler are implemented to display the spatial relation of anatomic landmarks of peri-implant tissues and to visualize the flow velocity and blood volume, respectively. It provides a valuable real-time diagnostic tool to evaluate hard and soft tissue remodeling and tissue perfusion changes during the early healing stage around IIP, comparing CTG and VCMX grafting. Hence, the purpose of this three-arm RCT is to compare the clinical efficacy and longitudinal remodeling of hard and soft tissue around IIP among CTG, VCMX, and control (without soft tissue augmentation) group. This will be the first evidence of the longitudinal tissue changes around immediate implant, and the first RCT comparing the clinical efficacy and esthetic outcome of xenogenic soft tissue substitute (i.e., from the non-living bone of another species) to the gold standard approach (CTG) on the immediate implants.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 18-95
  • •Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to first premolar, tooth #5-tooth #13)
  • •Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque score (FMPS) of less than 25%)
  • •Adequate tooth space to support an immediate implant placement (i.e., adequate mesiodistal space of greater than or equal to 6 mm and interocclusal space to support a non-occluding provisionalization).
  • •Postextraction vertical bone defect of the buccal socket wall was less than or equal to 3mm.

排除标准

  • •patients taking long-term (more than 3 months) medications affecting bone metabolism
  • •generalized untreated periodontitis with greater than of 30% of sites with greater than 5mm pocket depths and bleeding upon probing with a dental probe
  • •medical contraindications for having a surgical procedure (i.e., ASA Status of III, patient with a severe systemic disease that is not life-threatening; ASA Status of IV, a patient with a severe systemic disease that is a constant threat to life).
  • •history of radiotherapy in the head and neck region
  • •heavy smoker (greater than 10 cigarettes per day)
  • •pregnancy
  • •gingival recession before extraction in relation to the contralateral tooth.

研究组 & 干预措施

No Soft Tissue Augmentation

No Intervention

Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement.

Tuberosity Connective Tissue Graft (CTG)

Experimental

Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement.

干预措施: Tuberosity Connective Tissue Graft (CTG) (Procedure)

Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft

Experimental

Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement.

干预措施: Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation (Device)

结局指标

主要结局

Percentage of Participants That Had an Implant That Survived 6 Months After Immediate Implant Placement Either With or Without Soft Tissue Grafting

时间窗: 6 months after immediate implant placement

For participants that had immediate implant placement either with or without soft tissue grafting, this outcome is determined via clinical evaluation of the percentage of participants that still had their 1 implant in place after 6 months. Note: Only 1 implant was placed per participant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaoping Zhang

Associate Professor

University of Iowa

研究点 (1)

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