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临床试验/NCT06540690
NCT06540690招募中不适用

Comparison of Palatal Wound Healing in Diabetic and Non-diabetic Patients: Controlled Clinical Trial and in Vitro Study

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Open Wound Area (OWA)

研究概览

简要总结

This study aims to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients, evaluate clinical, patient-centered and immunological parameters as well as wound microbiome composition.

详细描述

The use of autogenous grafts from the palate for the reconstruction of gingival tissues is considered the gold standard for various periodontal and peri-implant reconstructions. Given the current aging of the population, it is essential to understand the cellular mechanisms responsible for the repair response in oral tissues and how they are affected by systemic diseases, such as diabetes mellitus (DM). The objectives of the present study, conducted through a controlled clinical trial, are to characterize and compare the closure of open wounds in the palatal mucosa of diabetic and non-diabetic patients. This will be achieved through clinical analyses, patient-centered parameters, inflammatory biomarkers, and wound microbiome composition. To accomplish this, 50 patients will be divided into two groups: the Diabetic Group (D; n = 25), where diabetic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft, and the Control Group (GC; n = 25), where normoglycemic patients will undergo surgery for mucogingival defect correction with the addition of a free gingival graft. The groups will be compared regarding clinical parameters, patient-centered measures, including remaining wound area, epithelialization, tissue thickness, immature wound area, tissue edema, early wound healing index, postoperative discomfort, quality of life, number of analgesics, and sensitivity of the operated area over a 3-month period. Furthermore, the wound biofilm will be described through microbiome analysis, and tissue, saliva, and wound exudate biomarkers will be characterized. Descriptive statistics will be expressed as mean ± standard deviation, clinical evaluations will be performed using repeated measures ANOVA, and patient-centered parameters will be assessed using the T-test. Finally, multiple linear regression and correlation tests will be employed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 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).
  • •Patients diagnosed with type 2 diabetes for more than 5 years who are using oral hypoglycemic agents or insulin supplementation, with HbA1c levels ranging from ≥ 6.1% to 8.5%.
  • •Non-diabetic patients with HbA1c levels below 6.1%.

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).

研究组 & 干预措施

Diabetic (D)

Active Comparator

Palatal wound healing in diabetic patients

干预措施: Palatal Wound (Procedure)

Control Group (CG)

Active Comparator

Palatal wound healing in normoglycemic patients

干预措施: Palatal Wound (Procedure)

结局指标

主要结局

Open Wound Area (OWA)

时间窗: baseline, 7, 14, 21 days after surgery

For this, standardized photographs will be taken. As a reference, a scale will be used to measure this area. These photographs will be exported to image software (Image J - National Institute of Health -NIH, Bethesda, USA), the area of the wound will be measured in square millimeters (Dias et al. 2015)

次要结局

  • Number of analgesics(14 days)
  • Patient Discomfort(14 days)
  • Epithelialization (E)(baseline, 7, 14, 21, 30 e 90 days after surgery)
  • Early wound healing index (EWHI)(7 and 14 days after surgery)
  • Tissue Thickness (TT)(baseline, 90 days after surgery)
  • Immunologic Analysis(baseline, 3, 7 days)
  • Qualitative somatosensory testing (QualST)(7, 14 days)
  • Tissue Analysis(baseline)
  • Tissue Edema (TE)(7 days)
  • Oral Health Impact Profile (OHIP)(14 days)
  • Saliva Analysis(baseline, 7 days)
  • Microbiome Analysis(baseline, 7, 14, 21, 30 e 90 days after surgery)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mauro Pedrine Santamaria

Associate Professor

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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