Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1a)
研究概览
简要总结
Gum disease and type 2 diabetes are common chronic diseases that affect each other. Diabetes is increasing, especially in Pakistan. People with diabetes have a greater risk for gum disease. Also, it is thought that that gum disease, a chronic infection, can be a source of systemic inflammation and may contribute to poorer diabetes control.
The aims of this project are to study:
- Changes in sugar control in people with type 2 diabetes and severe gum disease after having all teeth removed and replaced with Straumann dental implants and full dentures
- Changes in certain inflammation markers seen with insulin resistance and other diseases and conditions more common in people with diabetes
- Retention of dental implants in people with type 2 diabetes.
Part I (up to 12 months after implant placement):
The study will recruit 30 patients with type 2 diabetes and severe gum disease from Dr. Amin Rahman's private practices in Pakistan. Their long-term sugar (HbA1c) must be 7.5% or more and the inflammatory marker, C-reactive protein (hsCRP) 1mg/dL or more. Consenting participants will first have an oral examination. Eligible patients will have impressions of the jaws and the color of their teeth and gums recorded. At the next visit, all teeth will be extracted and dentures provided. One week later, there will be a check-up visit. Three months after the teeth were removed, Straumann dental implants will be placed in the jaws. After one week, the patient will be checked again. After three months, the dentures will be adjusted to fit the implants. Follow-up visits will occur every three months until one year after the implants were placed to check the health of the patients as well as their implants, the gums around them, and the dentures. Blood samples will be taken at each follow-up visit.
Part II (from 12 months to 11 years after implant placement):
Follow-up visits will occur every six months for the next ten years, to check the health of the patients as well as their implants, the gums around them, and the dentures. The follow-up visit will be identical to those done in Part I, including blood samples.
详细描述
Part I:
Our hypotheses are that levels of HbA1c and hsCRP will:
- decrease after extraction of all teeth
- not increase after placement of dental implants
- not increase after prosthetic restoration with full dentures anchored on the dental implants.
Part II:
Our hypothesis is that:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Procedure/Surgery (Impants/Overdentures)
One-arm clinical intervention study: All teeth out, full dentures, dental implants, blood draw. The interventions are not experimental in nature, they are standard procedures, namely extraction of all natural teeth followed by suturing to hold soft tissue in place during initial healing; surgical insertion of commercially available dental implants; and fabrication and re-lining (filling in with acrylic the base of the denture as needed during healing and shrinking of underlying tissue) of full dentures, that is full plates in upper and lower jaw to replace all teeth.
干预措施: Procedure/Surgery (Procedure)
结局指标
主要结局
Glycosylated hemoglobin (HbA1a)
时间窗: Every 3 months/6 months
Level measured every 3 months during the first year after implant placement; then every 6 months the following 5 years, for a total of 6 years.
次要结局
- high-sensitivity C-reactive protein (hsCRP)(Every 3 months/6 months)
研究者
Wenche S. Borgnakke DDS MPH PhD
Adjunct Clinical Assistant Professor
University of Michigan