Clinical trial NCT01774942: Taking Out All Teeth and Replacing Them With Dentures That Rest on Implants in People With Type 2 Diabetes
Official title: Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus With Periodontal Complication
Inflammation
Dental Implant Failed
Keywords: Diabetes Mellitus
C-Reactive Protein
Dental Implants, Single-Tooth
Dental Prosthesis, Implant-Supported
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Rahman & Rahman Dental Surgeons, Lahore, Pakistan
First posted: 2013-01-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Because it is unethical to withhold treatment that is known to be efficacious for severe periodontal infections, there is no control group that would not be treated or that would receive delayed treatment. Enrollment criteria included end-stage ("terminal") periodontal infection of all teeth, which is a condition that must be treated immediately due to its severity and potential for very severe consequences.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Part I:

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.

Part II:

Our hypothesis is that:

a) the implants will be retained over the long term

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. It would be unethical to withhold or delay treatment that is known to work, especially because such severe gum infection can have very serious consequences. Therefore, no control group was included in study.

Few 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 11 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 uncontrolled or poorly type 2 diabetes and severe gum disease. The option of implant supported dentures could potentially be added to the treatment choices for such patients.

Eligibility criteria: Inclusion criteria:

* type 2 diabetes of at least 6 months duration and uncontrolled (HbA1c at least 7.5%)
* all teeth in dentition in need of extraction due to periodontal (gum) disease (end-stage or terminal periodontitis)
* able to return for examination every three months for the first year after implant placement, then every 6 months for five years after implant placement
* willing to have blood drawn at each follow-up visit

Exclusion criteria:

* ≤ 6 natural teeth
* inflammatory conditions/diseases other than type 2 diabetes

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1a)
timeFrame: Every 3 months/6 months
Secondary outcomes:
measure: high-sensitivity C-reactive protein (hsCRP)
timeFrame: Every 3 months/6 months
Other outcomes:
measure: Retention of implants
timeFrame: 6 years
Locations:
city: Lahore
country: Pakistan
facility: Rahman & Rahman Dental Surgeons
state: Punjab
Study officials:
affiliation: University of Michigan
name: Wenche S Borgnakke, DDS MPH PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rahman & Rahman Dental Surgeons, Lahore, Pakistan
name: Amin ur Rahman, BDS MPH Cert
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: William V Giannobile, DDS MS DMSc
role: STUDY_CHAIR
References: