Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus with hyperglycemia, inflammation, post-osseointegration mechanical failure of dental implant
Treatment all teeth out, full dentures, dental implants, blood draw
Phase phase 1/phase 2
Sponsor Wenche S. Borgnakke DDS MPH PhD
Collaborator Rahman & Rahman Dental Surgeons, Lahore, Pakistan
Start date June 2008
End date December 2011
Trial size 30 participants
Trial identifier NCT01774942, #539-2007; #807_2011, HUM00027142

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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
all teeth out, full dentures, dental implants, blood draw
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.

Primary Outcomes

Measure
Glycosylated hemoglobin (HbA1a)
time frame: Every 3 months/6 months

Secondary Outcomes

Measure
high-sensitivity C-reactive protein (hsCRP)
time frame: Every 3 months/6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - type 2 diabetes - all teeth in dentition in need of extraction due to periodontal(gum) disease - able to return for examination every three months for first year, then every 6 months for five years after implant placement - willing to have blood drawn at each follow-up visit Exclusion Criteria: --other inflammatory conditions/diseases than type 2 diabetes

Additional Information

Official title Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study
Principal investigator Wenche S Borgnakke, DDS MPH PhD
Description Only one arm was included due to ethical reasons: Once potential participants would be diagnosed with terminal periodontal (gum) disease, they would need full-mouth extraction and prosthetic rehabilitation. Therefore, no control group was included in study. No studies have determined what happens to sugar control and inflammatory markers in people with diabetes if teeth with severe gum disease are removed and replaced with implants and dentures. Neither has any study followed for a total of 6 years after implant placement such subjects that initially had uncontrolled type 2 diabetes as well as recent severe periodontal infection, and several of whom smoke cigarettes. Therefore, the results of this study could add new understanding about diabetes and dental health. The results of this study could influence dental care guidelines for treating people with type 2 diabetes and severe gum disease. The option of implant supported dentures could potentially be added to the treatment choices for such patients.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Michigan.