Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Open and Closed Wounds
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Remaining wound area (RWA)
研究概览
简要总结
The goal of this clinical trial is to evaluate local and systemic factors involved in palatal mucosal healing after Free Gingival Graft harvest in diabetic patients and to compare them with those in non-diabetic patients.
Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:
- If the palatal wound healing (area of the wound) and percentage of wound epithelialization are different in diabetics compared to non-diabetics.
- If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.
Participants will be asked:
- Receive the procedure to treat their gingival recession defects
- To attend follow-up visits at 7, 14, 30, and 90 days after treatment.
- To provide different biological samples
- To answer different questionnaires.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥ 18 years;
- •non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- •in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- •periodontal stable (BoP ≤25%)(Lang et al. 2003);
- •no morphological or pathological conditions in the palatal mucosa.
排除标准
- •patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- •taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- •Pregnancy/lactation (assessed via self-report);
- •current opportunistic oral lesions that mainly colonize the palate region;
- •subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
- •prisoners;
- •signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
- •subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
研究组 & 干预措施
Diabetes group
Diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.
干预措施: Free gingival graft (Procedure)
Non-diabetes group
Non-diabetic volunteers with gingival recession will be treated with coronally advanced flap and connective tissue graft (CTG). The CTG will be obtained by harvesting a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm from the palatal area between the distal of the canine and the mesial aspect of the first molar. The palatal wound will be evaluated.
干预措施: Free gingival graft (Procedure)
结局指标
主要结局
Remaining wound area (RWA)
时间窗: 3 months
The RWA will be measured in square millimeters using software (Image J- NIH, Bethesda, Maryland, USA) at baseline (trans-operative) and 1, 2, 4, and 12 weeks after the surgery
次要结局
- Epithelialization - EPT(3 months)
- Insomnia Severity Index Survey(Baseline and up to 4 weeks)
- Tissue thickness - TT(3 months)
- Inflammatory markers(2 weeks)
研究者
Mauro Santamaria
Associate Professor
University of Kentucky