NCT00587834已完成3 期
A Clinical Trial to Evaluate Gintuit (TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) as an Alternative to Tissue From the Palate to Enhance Oral Soft Tissue Regeneration and Wound Healing
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 8
- 主要终点
- Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
研究概览
简要总结
The purpose of this study is to evaluate Gintuit as a safe and effective alternative to palatal tissue in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingiva associated with at least two nonadjacent teeth.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age but no more than 70 years of age.
- •Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with an insufficient zone (< or = 1mm) of attached gingiva that requires soft tissue grafting. (1-3 teeth may be treated. In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment).
- •Root coverage is not desired at the time of grafting.
- •Females of childbearing potential must have a documented negative urine pregnancy test.
- •Subjects must have read, understood and signed an institutional review board (IRB) approved Informed Consent Form.
- •Subjects must be able and willing to follow study procedures and instructions.
排除标准
- •Subject with class III recession in the presence of a shallow vestibule or class IV recession.
- •Subject with vestibule depth of less than 7mm from base of recession.
- •Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (i.e., diabetes mellitus, cancer, human immunodeficiency virus (HIV), bone metabolic diseases).
- •Subject who is currently receiving or has received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- •Subject with the presence of acute infectious lesions in the areas intended for surgery.
- •Subject who has used any tobacco product within 3 months.
- •Subject who is taking intramuscular or intravenous bisphosphonates.
- •Subject with only molar teeth suitable for soft tissue grafting.
- •Subject with teeth that have Miller Grade 2 or higher mobility.
- •Subject with known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
- •Subject who has received an investigational drug or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
- •Subject who was previously treated with Gintuit, Dermagraft or any other skin graft at the target site(s) or immediately adjacent teeth.
- •Subject, 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.
结局指标
主要结局
Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.
时间窗: 6 months
The superiority of Gintuit relative to a pre-defined standard (50% success) for a 2 mm KT threshold after six months.
次要结局
- Percentage of Subjects With at Least 1 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.(6 months)
- Pain Absent After 3 Days (Superiority)(Day 3)
- Texture Same as Adjacent Tissues After 6 Months (Superiority)(6 months)
- Surgical Site Sensitivity Mild or Absent After 1 Week(Superiority)(6 months)
- Patient Preference After 6 Months/Early Termination (Superiority)(6 months)
- Color Same as Adjacent Tissues After 6 Months (Superiority)(6 months)
研究者
研究点 (8)
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