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Post-osseointegration Mechanical Failure of Dental Implant clinical trials

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NCT ID: NCT01774942 Unknown status - Inflammation Clinical Trials

Taking Out All Teeth and Replacing Them With Dentures That Rest on Implants in People With Type 2 Diabetes

Start date: June 2008
Phase: Phase 1/Phase 2
Study type: Interventional

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: 1. 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 2. Changes in certain inflammation markers seen with insulin resistance and other diseases and conditions more common in people with diabetes 3. Retention of dental implants in people with type 2 diabetes. 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, then every six months for the next five years, 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. Our hypotheses are that levels of HbA1c and hsCRP will: 1. decrease after extraction of all teeth 2. not increase after placement of dental implants 3. not increase after prosthetic restoration with full dentures anchored on the dental implants.