Wound Healing After Tooth Extraction in Individuals With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wound healing change after tooth extraction through epithelialization
研究概览
简要总结
Dental treatment to individuals with diabetes mellitus, particularly type 1 diabetes (T1DM), has always represented a challenge to the dentist. The literature provides some scientific evidence showing that diabetes is a risk factor for the occurrence of oral opportunistic infections, abnormal bone metabolism and delay in tissue repair, but with varying degrees of evidence.
Hyperglycemia, as well as diabetes, are known as risk factor for post-surgical infections, so maintaining the glycemic control in the postoperative period has been standard to health care. However, there are few studies on the impact of the glycemic control in the repair process after tooth extractions. And, to our knowledge, there aren't evidences that infections resulting from oral surgery are more frequent in individuals with diabetes or that the antibiotics prophylaxis is needed for these individuals before invasive dental procedures.
Some prospective studies show that people with diabetes, especially type 2 (T2DM), do not exhibit higher frequency of complications in repair process after tooth extractions compared to healthy individuals without diabetes. Recently, the study conduct by Fernandes et al., 2015, found higher frequency of delay on epithelial covering of the alveolus after 21 days of tooth extraction in individuals with T2DM, comparing to a control group. Delay was not related to infection and on the day 60th after surgery, all alveolus were totally epithelized. One of the author's hypothesis for the delay in the alveolar epithelialization on the participants with T2DM was the possible reduction of Epithelial Grow Factor (EGF) in saliva of these individuals. Some studies already demonstrated the reduction in salivary detection of EGF in individuals with diabetes.
There aren't prospective studies in the literature at our disposal, that evaluated intraoperative complications of tooth extractions of teeth already erupted in individuals with T1DM, or even post tooth extraction healing and the chronology of epithelialization of the alveolus and its relation with the degree of salivary EGF.
The aim of this study is to evaluated the intraoperative events and the post- tooth extraction healing, regarding the chronology of the repairing events and the occurrence of postoperative complications in individuals with T1DM compared to a control group. Besides, this study intend to relate the time of complete epithelial covering of the alveolus with the EGF collected by whole stimulated saliva.
详细描述
This prospective, longitudinal, case-control study will include 30 subjects with type 1 diabetes mellitus who require extraction of 1 or more erupted teeth, which will make part of study group (SG). Other 30 healthy subjects, without diabetes mellitus, in need of tooth extraction will make part of control group (CG). The groups will be matched by gender and age.
This project will be submitted to the Research and Ethics Committee of Dentistry College in University of Sao Paulo and all participants will sign a Consent Term.
All subjects who agreed to participate of this research will sign the Consent Term. A questionnaire will be filled by the researcher, through information obtained by direct questioning of the participant, contaning demographic data (gender, age), medical history, dental history, medications and other health problems.
After anamnesis, the researcher will make a clinical evaluation of oral health to see the necessity of tooth extractions. If there is any indication of tooth extraction, a periapical radiograph will be performed. Also, will be required complimentary blood exams with blood count, fasting glycemia and coagulation factors. Subjects that will be in use or that made use antibiotics at least a month before the tooth extraction will be excluded from this study.
On the day of the surgical procedure, will be measured, in the individuals of SG, quick exams of glicated hemoglobin (A1C) through the equipment A1C Now+ Multi-Test HbA1c System Bayer®. The glycaemia will be measured with the equipment Accu-Check®, before and after the tooth extraction and in each appointment of post-surgery (Day 3, Day 7, Day 21, Day 60). The blood pressure will also be measured before and after the tooth extraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Individuals with type 1 diabetes mellitus for study group
- •Healthy individuals without diabetes mellitus for control group
排除标准
- •under 18 years old
结局指标
主要结局
Wound healing change after tooth extraction through epithelialization
时间窗: 60 days after surgery
Evaluation of repair and possible complications of the surgical wound will be held in 4 different moments, on day 3, 7, 21 and 60 after surgery. These evaluation it will always be perform by the researcher, trained and calibrated. Will be observed signs and symptoms such as edema, erythema, bone exposure, fever, pain and analgesic need. The repair process will be considered late when the following events do not match the period considered normal: day 3- alveolus filled by blood clot and fibrin; day 7- alveolus filled with granulation tissue; day 21- complete epithelialization of the wound; day 60- alveolus exhibiting bone deposition, radiographically observed.
次要结局
- Number of participants with abnormal laboratory values(Within 30 days before the tooth extraction)
- Adverse events that are related to the surgery(up to 3 hours before surgery)
- Epidermal Grow Factor (EGF)(after the saliva collection of all participants the samples will be frozen at -80 Celsius degrees. The EGF of the samples will be analyzed by the end of all patients collection (after 1 years collection))
- Salivary flow(Before surgery with 5 minutes collection)
- Radiographic analysis of bone repair(Between day 7 and day 60 after tooth extraction)
研究者
Marina Helena Cury Gallottini
Professor
University of Sao Paulo