NCT01929954终止1 期
Phase 1/2, Randomized, Controlled Assessment of the Safety Of Gintuit™ Versus Bio-Gide® in Subjects Requiring Socket Grafting
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).
详细描述
This study will evaluate the safety of GINTUIT as compared with Bio-Gide in subjects who have a posterior tooth requiring extraction. The use of GINTUIT in this investigational clinical indication may eliminate/reduce the need for aggressive flap advancement with its concomitant morbidity, while, at the same time, obtaining stable closure over a grafted socket. It is anticipated that GINTUIT will facilitate tissue granulation, followed by tissue coverage with site appropriate tissue (ie, keratinized tissue) that is needed for long term stability of the final restoration.
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
- •Subject is at least 18 years of age but no more than 75 years of age.
- •Subject has a posterior (molar or premolar) socket created by atraumatic extraction with a post extraction socket of a minimum of 5 mm in both the mesial-distal (M-D) and buccal-lingual (B-L) dimensions that requires bone grafting.
- •Subject has sufficient buccal bone plate at the site of the planned tooth extraction (ie, the residual socket should be of a form that would retain bone graft material), as judged by the Principal Investigator.
- •Females of childbearing potential must have a documented negative urine pregnancy test. All subjects must agree to use acceptable methods of contraception for the duration of the study.
- •Subjects must have read, understood, and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
- •Subjects must be able and willing to comply with protocol requirements.
排除标准
- •Subject with any systemic conditions that could compromise wound healing and preclude periodontal surgery (ie, bleeding disorder, cancer, except localized basal cell or squamous cell cancer of the skin with no metastasis; human immunodeficiency virus; or bone metabolic diseases [ie, osteoporosis or Paget's disease]).
- •Subject who is currently receiving, anticipates receiving or has received within 30 days prior to Day 0: inhaled or systemic corticosteroids (ie, oral, IV), immunosuppressive agents or radiation therapy, and/or chemotherapy, which could compromise wound healing and preclude periodontal surgery.
- •Subject who has had oral/periodontal surgery within 30 days prior to Day 0 or anticipates having oral/periodontal surgery within 30 days after Day
- •Subject with acute mucosal infection, including suppuration or induration in the area of intended surgery.
- •Subject, who in the opinion of the Principal Investigator, will require a sinus lift procedure to place dental implants in the surgical area.
- •Subject without at least 1 tooth adjacent to the area to be treated.
- •Subject has a history of alcohol or substance abuse within the previous 12 months of Screening that could interfere with study compliance or protocol requirements.
- •Subject who has used any tobacco product within 6 months of Screening.
- •Subject with known hypersensitivity to porcine or bovine collagen, gentamicin or surfactants.
- •Subject who has received an investigational drug, device, or biological/bioactive treatment within 30 days prior to Day 0 (medical or dental).
- •Subject who was previously treated with Gintuit, or any other cell therapy at the target treatment site or immediately adjacent teeth.
- •Female subject that is lactating.
- •Subject, who in the opinion of the Principal 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
Number of participants with adverse events
时间窗: up to 12 months post treatment
次要结局
- Bone quality(Up to 6 months post treatment)
- Percentage of participants with soft tissue closure(Up to 4 weeks post treatment)
- Percentage of participants with convex, normal and concave soft tissue contour(Up to 6 months post treatment)
- Measurements of soft tissue ridge height(Up to 6 months post treatment)
- Measurements of ridge width of hard tissue(Up to 6 months post treatment)
- Measurements of bone height(Up to 6 months post treatment)
- Number of participants with visible loss of graft material(Up to 3 months post treatment)
- Measurement of soft tissue ridge contour(Up to 6 months post treatment)
- Percentage of participants with color and texture match(Up to 6 months post treatment)
- Optimal product configuration (ie, single, folded, or z-folded)(One month after placement of Gintuit in the last subject in the last successful cohort)
- Measurement of soft tissue thickness(Up to 6 months post treatment)
- Percentage of participants with a clinically significant physical reduction of crestal ridge height(Up to 6 months post treatment)
- Number of participants reporting loose graft material(Up to 21 days post treatment)
- Gintuit product handling(At Day 0)
- Percentage of participants with acceptable implant stability(Up to 12 months post treatment)
研究者
研究点 (2)
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