Taking Out All Teeth and Replacing Them With Dentures That Rest on Implants in People With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01774942|
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : November 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus With Periodontal Complication Inflammation Dental Implant Failed||Procedure: Procedure/Surgery||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study|
|Actual Study Start Date :||June 1, 2008|
|Actual Primary Completion Date :||August 28, 2015|
|Actual Study Completion Date :||August 28, 2015|
Experimental: 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.
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.
Other Name: All teeth out, full dentures, dental implants, blood draw
- Glycosylated hemoglobin (HbA1a) [ Time Frame: 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.
- high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 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.
- Retention of implants [ Time Frame: 6 years ]Implants sometimes fail if placed in individuals with uncontrolled diabetes, recent infection/inflammation, and cigarette smoking habits. The intent is to evaluate retention of implants in such patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774942
|Rahman & Rahman Dental Surgeons|
|Lahore, Punjab, Pakistan|
|Principal Investigator:||Wenche S Borgnakke, DDS MPH PhD||University of Michigan|
|Study Director:||Amin ur Rahman, BDS MPH Cert||Rahman & Rahman Dental Surgeons, Lahore, Pakistan|
|Study Chair:||William V Giannobile, DDS MS DMSc||University of Michigan|