3D Printed Scaffold Device for Ridge Preservation After Tooth Extraction - A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Alveolar ridge resorption
研究概览
简要总结
Following tooth extraction, the socket heals naturally with bone in 1 to 2 months. This healing process occurs with substantial reduction of the original height and width of the alveolar ridge. In a significantly resorbed ridge, bone augmentation procedures are necessary before dental implant placement. Autogenous bone is the gold standard for this purpose but the harvesting procedure results in additional morbidities and expenses. Ridge preservation techniques have been introduced, using xenografts, allografts or synthetic materials to fill the tooth socket immediately after extraction. While the current materials used have improved ridge dimensions to various extents, their osteoconductivity is suboptimal and unpredictable. They do not reduce vertical resorption of the bony walls and often interfered with the normal healing process. Polycaprolactone - tricalcium phosphate (PCL-TCP) is a bioactive, bioresorbable composite polymer that is non-toxic and tissue-compatible. This study will test the use of a novel 3D printed PCL-TCP device for ridge preservation, leveraging on its 3D shape that fits snugly in the tooth socket, high porosity and bioactivity to promote osteogenesis and reduce resorption. The hypothesis is that the insertion of a PCL-TCP scaffold in extraction sockets allows normal bone healing and better maintenance of ridge dimensions after 6 months compared to extraction sockets without a space filler. This will be a prospective, randomized controlled clinical trial in patients who require single tooth extraction and replacement with a dental implant. The study will compare the ridge dimensions and the quality and quantity of bone formed in tooth sockets, using histology and microcomputed tomography, in both groups after 6 months. The PCL-TCP scaffold to be used in this study will be fabricated by a local spin-off company, Osteopore International Pte Ltd. The market potential for this device is tremendous due to a growing demand for tooth replacement from an ageing population worldwide.
详细描述
This will be a prospective, non-blinded randomized controlled clinical trial in adult patients who require single tooth extraction and who are suitable for dental implant therapy after extraction. The participants will be randomised by a clinician, using sealed envelopes that has been prepared by an independent party, to either the test or control group on a 1:1 ratio:
Test Group: insertion of PCL-TCP scaffold after tooth extraction Control Group: no space filler after tooth extraction
Proposed study interventions 110 patients who give written consent to participating in the study will be recruited from the Departments of Oral & Maxillofacial Surgery and Restorative Dentistry at the NDCS.
Patient may re-participate in the study for a different suitable teeth site. The re-participation(s) may take place on the same or a separate visit.
Pre-extraction Preparation Dental models and standardised dental radiographs, including periapical and orthopantomogram, will be taken. A customised acrylic dental stent will be fabricated as a reference tool for standardised measurement of ridge dimensions. Three markings will be made (mesio-buccal, mid-buccal, disto-buccal) on the acrylic stent at the intended extraction site.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be above 21 and below 70 years of age (both inclusive)
- •Patient must be of ASA I or ASA II classification
- •Patient who requires single tooth extraction
- •Patient whose tooth to be extracted is bounded by adjacent teeth
- •Patient who is suitable for dental implant therapy after extraction
- •Patient with any pre-existing infection or abscess at the site of tooth extraction must be treated and resolved first prior to inclusion in the study
排除标准
- •Patient with known allergy to biopolymer materials
- •Patient who are smokers
- •Patient who has undergone therapeutic radiation for head and neck malignant disease
- •Maxillary lateral incisor and molars; or mandibular central and lateral incisor extraction sites
- •Extraction sites with insufficient vertical bone height for implant placement without additional bone grafting (such as sinus lift procedure)
研究组 & 干预措施
PCL-TCP scaffold
During the surgery, the PCL-TCP scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A Geistlich Bio-Gide collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
干预措施: PCL-TCP scaffold (Device)
PCL-TCP scaffold
During the surgery, the PCL-TCP scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A Geistlich Bio-Gide collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
干预措施: Geistlich Bio-Gide collagen membrane (Device)
Geistlich Bio-Gide collagen membrane
No space filler will be inserted in the extraction socket but similar to the test group, a Geistlich Bio-Gide collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
denture overlying the extraction site will be completely relieved.
干预措施: Geistlich Bio-Gide collagen membrane (Device)
结局指标
主要结局
Alveolar ridge resorption
时间窗: 6 months post-extraction
This will be measured indirectly as the vertical distance from each reference marking on the stent to the marginal bone of the tooth socket at the mesio-buccal, mid-buccal and disto-buccal aspects
次要结局
- Stability of dental implant(6 months post-extraction)
- Quality of bone tissue formed in tooth sockets(6 months post-extraction)
- Quantity of bone tissue formed in tooth sockets(6 months post-extraction)
- Healing and inflammatory response in tooth sockets(6 months post-extraction)
研究者
Goh Bee Tin
Senior Consultant, Department of Oral & Maxillofaical Surgery, Clinical Associate Professor, Director of Research, NDCS
National Dental Centre, Singapore