跳至主要内容
临床试验/NCT05663385
NCT05663385招募中不适用

Alveolar Ridge Preservation With a Xenograft (Bio-Oss® Collagen) and a Collagen Matrix (Mucograft® Seal) or a Free Connective Tissue Graft Versus Spontaneous Healing:A 5-year Follow up

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
buccal marginal gingival level

研究概览

简要总结

Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading.

Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading

Study design: prospective observational study with 5-year follow-up

Intervention (if applicable): not applicable

Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing

Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.

详细描述

Replacement of a single tooth in the esthetic zone is a demanding procedure. For optimal esthetic results, no deficiency in both bone and soft tissue is acceptable. Immediately after tooth extraction, the alveolar ridge undergoes horizontal and vertical bone loss. This negatively influences the soft tissue contours, and thus esthetic outcome. Although immediate placement of an implant after extraction leads to acceptable esthetic results, there is an increased risk of mucosal recession due to the lack of adequate soft tissue. Early implant placement, 4 to 8 weeks after extraction, may offer advantages in terms of soft and hard tissue preservation. The main goals when treating the extraction socket in the esthetic zone is to preserve as much as possible existing soft and hard tissue volume as possible for future implant placement. Landsberg described a modified ridge preservation technique called "socket seal surgery" where flap elevation is avoided and it combines both bone and soft tissue grafting prior to implant placement. Closing the extraction site from the oral cavity using a thick epithelized palatal graft enables optimal ridge preservation immediately after tooth extraction. Jung showed that the application of a slowly resorbing biomaterial (BioOss Collagen®, Geistlich) into an extraction socket, covered with an autogenous palatal soft tissue punch graft resulted in a high predictability and reliability for a good esthetic result for future (early) implant placement. Although a soft tissue graft is a relatively easy procedure, patient morbidity is often associated with the second surgical site. An artificial socket seal might prevent donor morbidity associated with soft tissue grafts. A critical determinant for stable esthetic long-term outcomes is integrity and stability of the facial bone wall. The application of a biomaterial into an extraction socket, covered with a collagen matrix or a soft tissue graft, resulted in less vertical and horizontal changes of the alveolar ridge 6 months after extraction. Although there seems to be no difference in the long term change of the buccal soft tissue contour and alveolar ridge between a collagen matrix and an autogenous soft tissue punch graft, there is a lack in data concerning the difference in esthetic outcome between these two methods in early implant placement. Therefore, we evaluated esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with alveolar ridge preservation(ARP) with a xenograft (Bio-Oss® Collagen) and a collagen matrix (Mucograft® Seal) or a free connective tissue graft versus spontaneous healing up to 1 year after functional loading (MEC-2015-016;NL49965.078.14). This study showed that ARP using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, resulted in less bone resorption and fewer bone augmentation procedures at early implant placement compared to spontaneous healing. One year after functional loading, there was no difference in clinical and esthetical outcomes and similar PROMS between the three treatment modalities. In order to achieve optimal esthetic results, both the bone and soft tissue have to be preserved as good as possible. Not much is known about the long term stability of ARP compared to spontaneous healing and PROMs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients previously included in the above mentioned RCT.

排除标准

  • Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.

结局指标

主要结局

buccal marginal gingival level

时间窗: 5 year

1. Is the buccal marginal gingival level (midfacial mucosa level) of implants treated post-extraction with a bone substitute material (BioOss® Collagen) and a collagen matrix (Geistlich Mucograft® Seal) (Group A) or covered with a palatal graft (Group B) more favorable then the buccal marginal gingiva in spontaneous healing (Group C) up to 5 year after functional loading?

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

Dr. Justin Pijpe

Assistent Professor

Erasmus Medical Center

研究点 (1)

Loading locations...

相似试验