OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- New bone formation
研究概览
简要总结
The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.
详细描述
After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.
OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.
Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 75-yrs of age.
- •Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement.
- •Proposed treatment site must have intact buccal cortical plates > 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate).
- •Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants).
- •Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
- •Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- •Subjects must be able and willing to follow study procedures and instructions.
排除标准
- •Subjects with reported allergy or hypersensitivity to any of the products to be used in the study.
- •Subjects with untreated / active periodontal disease.
- •Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
- •Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco.
- •Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer)
- •Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
- •Subjects who would require a tissue supported interim prosthesis i.e. acrylic / valplast RPD (tooth supported interim prostheses i.e. essix retainers are acceptable)
- •Subjects with long-term history of oral bisphosphonates (> 10 years).
- •Subjects with a history of intravenous bisphosphonates.
- •Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia)
- •Subjects taking corticosteroids or immunosuppressants on a regular basis prior to baseline examination.
- •Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis who are not medically cleared to hold medication prior to and during procedure.
- •Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- •Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
研究组 & 干预措施
OsteoGen Plug
OsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket.
干预措施: OsteoGen Plug (Device)
BioGide
This product is SOC treatment and will be used per packaging instructions.
干预措施: BioGide (Device)
结局指标
主要结局
New bone formation
时间窗: 120 days
new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120
次要结局
- Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)(120 days)