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

Summary

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.

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.

Conditions

• Type 2 Diabetes Mellitus With Periodontal Complication
• Inflammation
• Dental Implant Failed

Interventions

PROCEDURE

Procedure/Surgery

All teeth were extracted and replaced by a set of provisional full dentures in upper and lower jaws. Three months after extractions, dental implants were surgically placed and mucosa sutured over them. Three monts later, the dentures were re-lined and fitted onto the implants. Blood draw done by phlebotomist.

Sponsors & Collaborators

• Rahman & Rahman Dental Surgeons, Lahore, Pakistan

  collaborator OTHER

• University of Michigan

  lead OTHER

Principal Investigators

• Wenche S Borgnakke, DDS MPH PhD · University of Michigan

• Amin ur Rahman, BDS MPH Cert · Rahman & Rahman Dental Surgeons, Lahore, Pakistan

• William V Giannobile, DDS MS DMSc · University of Michigan

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-01

Primary Completion

2015-08-28

Completion

2015-08-28

Countries

• Pakistan

Study Locations