Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on 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
- gingival recession reduction
研究概览
简要总结
The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment 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 gingival recession reduction and percentage of root coverage 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, 90, and 180 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
- Treatment
- 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
Non-diabetes group
干预措施: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) (Procedure)
Diabetes group
干预措施: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) (Procedure)
结局指标
主要结局
gingival recession reduction
时间窗: 6 months
The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values
次要结局
- Probing depth(6 month)
- Clinical attachment level(6 months)
- PROMIS Adult Sleep Disturbance Survey(Baseline and up to 4 weeks)
- Number of analgesics(7 days)
- Insomnia Severity Index Survey(Baseline and up to 4 weeks)
- Change in Dentin hypersensitivity(Baseline and up to 6 months)
- Discomfort(7 days)
- Root Coverage Esthetic Score(6 months)
- gingival crevicular fluid (GCF) inflammatory markers(6 months)
研究者
Mauro Santamaria
Associate Professor
University of Kentucky