A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
研究概览
简要总结
Prospective, randomized, within subjects-controlled design
详细描述
The objective of this trial is to evaluate clinical healing outcomes of microsurfaced cadaveric ADM (Markman Biologics) used in sites with < 1 mm of attached gingiva requiring soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm, LifeCell) over 180-day post-op period. During the treatment period, each site will be monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects will be seen at post-op day 7, 14, 30, 90, and 180.
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
- •Signed informed consent by patient or Legally Authorized Representative (LAR)
- •Patients with ≥2 non-adjacent teeth in the same jaw presenting with ≤ 1mm attached gingiva that requires soft tissue grafting without the need for root coverage
- •Patients with good oral hygiene as indicated by presence of minimal plaque and absence of material alba and calculus.
- •≥ 18 and ≤ 75 years of age
- •Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study.
排除标准
- •Vestibule depth <7mm from the base of recession
- •Systemic condition, such as uncontrolled diabetes mellitus, HIV, cancer, or bone metabolic disease that could compromise wound healing
- •Treatment with systemic corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within 2 months of enrollment in the study
- •Acute infection lesions in intended grafting sites
- •Received intravenous or intramuscular bisphosphonates
- •Tobacco use within 3 months of enrollment or for the duration of the study
- •Only molar teeth suitable for soft tissue grafting (molars may be treated but not assigned as the study tooth)
- •Miller grade ≥2 mobility on grafting sites or adjacent teeth
- •Known hypersensitivity to bovine collagen or iodine (shellfish allergy)
- •Previous treatment with an advanced biologic at sites selected fro grafting or the adjacent teeth
- •Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
- •Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
- •Active alcohol or substance abuse (including marijuana, THC, CBD oils and products) in the opinion of the investigator that could impair the subject's participation in the study.
- •Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
- •Known allergies to Cefoxitin, Gentamycin, Lincomycin, Polymyxin B, Vancomycin, or any antibiotic in these same classes.
- •Known allergy to Polysorbate 20
结局指标
主要结局
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
时间窗: Day 14 post op
graft failure by no evidence of keratinized tissue width
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss
时间窗: Day 14 post op
graft loss
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color
时间窗: Day 14 post op
tissue color
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture
时间窗: Day 14 post op
graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation
时间窗: Day 14 post op
tissue inflammation using a score of 0 (normal) to 4 (severe)
次要结局
- Assessment of Infection through 180 days(180 days)
- Subject Discomfort(through 180 days)
- Graft Healing(180 days)
- Change in recession(180 days)
- Change in keratinized tissue(180 days)
- Clinical Attachment level(180 days)
- Change in Probing depths(180 days)
- Change in gingival attachment(180 days)
- Healing as assessed by histological analysis(90 days post op)
- Occurrence of AEs/SAEs(through 180 days)