A New Drug Delivery System - Silk Fibroin Film Loaded or Not With Insulin on Palatal Mucosa Wound Healing: in Vitro Study and a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in the Remaining wound healing (RWA)
研究概览
简要总结
The aim of the present study is to evaluate using clinical, patient-centered, immunological, microbiological, and histological parameters, the effect of silk fibroin films loaded or not with insulin in the repair of palatal mucosa open wounds.
详细描述
There are several types of periodontal and peri-implant soft tissue defects that require surgical treatment to reestablishment function and aesthetics. Therefore, surgical procedures for the reconstruction of the gingival and peri-implant tissues are routinely performed. However, these procedures do not always have predictable outcomes, and problems with the wound healing process can occur, which can impair the outcomes. To overcome this problem, new materials, drugs, and devices have been used to improve the results of surgical procedures. The present study is a controlled clinical trial that will include seventy-five patients with an indication of anterior maxillary tooth extraction for ridge preservation. The ridge preservation will be performed and a free gingival graft harvest from the palatal mucosa will be used to seal the socket entrance. Thereafter, the palatal wound will be randomly assigned into 3 groups: Control Group (C; n=25): open wound on palatal mucosa that will receive no treatment. Blank Film Group (BF; n=25): open wound on palatal mucosa that will receive silk fibroin film as dressing. Insulin-loaded film (IF; n=25): open wound on palatal mucosa that will receive an insulin-loaded silk fibroin film as a delivery system. Clinical, immunological, histological, and microbiome parameters will be analyzed.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least 18 years, systemically healthy, with good oral hygiene, assessed by plaque index and gingival index less than 25% (Ainamo, Bay, 1975);
- •Patients with no morphological or pathological conditions on the palatine donor area;
- •Patients who present indication for extraction and ridge preservation;
- •The tooth included in the study, as well as, the adjacent teeth do not present loss of periodontal insertion;
- •Patients who agreed to and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the present study (Resolution no. 118 - May, 2012, and Ethics and Code of Professional Conduct in Dentistry - 118/12).
排除标准
- •Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
- •Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- •Smokers patients;
- •Pregnant or lactating patients;
- •Patients who had had periodontal surgery on the study area;
- •Patients who presents opportunistic oral lesions, mainly colonized the palate region;
- •Use of dental prosthesis with palatal cover;
- •Thin palatal mucosa (~2.0mm).
结局指标
主要结局
Change in the Remaining wound healing (RWA)
时间窗: 90 days.
Photographs will be taken from palatal wound with brightness, distance, and angle standardized. A scale will be placed in the palate as a reference to measure the area. These photographs will be exported to an image software (Image J - NIH, Bethesda, USA), and the wound area will be measured in square millimeters (Dias et al., 2015).
次要结局
- Early- wound healing index (EWHI)(14 days)
- Qualitative somatosensory testing (QualST)(14 days)
- Immunologic Analysis(7 days)
- Epithelialization (E)(90 days)
- Oral Health Impact Profile(14 days)
- Number of analgesics(14 days)
- Tissue Edema (TE)(7 days)
- Histological Analysis(180 days)
- Tissue Thickness (TT)(90 days)
- Patient Discomfort(14 days)
研究者
Mauro Pedrine Santamaria
Associate Professor
Universidade Estadual Paulista Júlio de Mesquita Filho