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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
Sponsor:
Collaborator:
Rahman & Rahman Dental Surgeons, Lahore, Pakistan
Information provided by (Responsible Party):
Wenche S. Borgnakke DDS MPH PhD, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus With Periodontal Complication Inflammation Dental Implant Failed Procedure: Procedure/Surgery Not Applicable

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
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.
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.
Other Name: All teeth out, full dentures, dental implants, blood draw




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Pakistan
Rahman & Rahman Dental Surgeons
Lahore, Punjab, Pakistan
Sponsors and Collaborators
University of Michigan
Rahman & Rahman Dental Surgeons, Lahore, Pakistan
Investigators
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

Additional Information:
Responsible Party: Wenche S. Borgnakke DDS MPH PhD, Adjunct Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01774942     History of Changes
Other Study ID Numbers: #539-2007; #807_2011
HUM00027142 ( Other Identifier: University of Michigan Medical School IRB )
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wenche S. Borgnakke DDS MPH PhD, University of Michigan:
Diabetes Mellitus
C-Reactive Protein
Dental Implants, Single-Tooth
Dental Prosthesis, Implant-Supported

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes