Palatal Donor Site Wound Healing Following Periodontal Plastic Surgery Using Amnion-Chorion Membrane: Site- and Patient-Centered Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Wound healing time
研究概览
简要总结
The purpose of this clinical trial is to assess if donor site healing in the palatal area and patient pain perception are similar or different when using amnio-chorion membrane (ACM) on the donor site after surgery compared to a commonly used commercial hemostatic agent (ActCel Cellulose Gauze).
详细描述
Resorbable oxidized cellulose materials are commonly used as hemostatic agents in medicine and dentistry. Surgicel and ActCel are used daily in surgical practice. When these products come in contact with blood, they convert to a gel that expands to cause direct pressure on blood vessels and control bleeding. ActCel is water-soluble and dissolves over a short time period. It can be removed easily when water, saline or hydrogen peroxide is applied.The study team will examine the effects of ACM as a wound dressing for the donor area and compare the rate of epithelialization with and without its use.
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
- Single (Participant)
盲法说明
Participants will be randomly assigned to either the hemostatic agent or the amnio-chrionic membrane, but will be blinded to which standard of care intervention to which they are assigned.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between age 18 and 89
- •Patients needing an FSTA in the area of the mouth from 2nd molar to 2nd molar in the maxilla or mandible at sites that have teeth or implants, or in sites that are edentulous
- •Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
- •Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
- •Must have access to Smartphone
排除标准
- •Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- •Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- •Pregnant women or women intending to become pregnant during study period
- •Smokers who smoke > 10 cigarettes per day
结局指标
主要结局
Wound healing time
时间窗: 1, 2, 3 and 4 weeks post-operatively
Change in Area of wound epithelialization will be measured in mm2 at 1, 2, 3 and 4 weeks postoperatively using an Early wound healing index (EHI) index. The index assesses 5 dichotomous variables, each with a "yes" or "no" assessment. "Yes" = score of 1; "No" = score of 2. Total score can range from 5 minimum to 10 maximum. The 5 variables are: * bleeding on palpation? * incomplete epithelialization? * presence of redness? * presence of swelling? * granulation tissue present?
Post-operative pain
时间窗: 24, 48 and 72 hours post-surgery
Change in pain will be assessed post surgery using a smart-phone application that captures the pain level in a scale of 1-10, where a lower number indicates a less pain
次要结局
未报告次要终点