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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00027142 | Other Identifier | University of Michigan Medical School IRB |
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| Name | Class |
|---|---|
| Rahman & Rahman Dental Surgeons, Lahore, Pakistan | OTHER |
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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:
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.
Part I:
Our hypotheses are that levels of HbA1c and hsCRP will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure/Surgery (Impants/Overdentures) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1a) | 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. | Every 3 months/6 months |
| Measure | Description | Time Frame |
|---|---|---|
| high-sensitivity C-reactive protein (hsCRP) | 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. | Every 3 months/6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of implants | 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. | 6 years |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenche S Borgnakke, DDS MPH PhD | University of Michigan | Principal Investigator |
| Amin ur Rahman, BDS MPH Cert | Rahman & Rahman Dental Surgeons, Lahore, Pakistan | Study Director |
| William V Giannobile, DDS MS DMSc | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rahman & Rahman Dental Surgeons | Lahore | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D015921 | Dental Implants |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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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.
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D008919 | Investigative Techniques |