Taking Out All Teeth and Replacing Them With Dentures That Rest on Implants in People With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Rahman & Rahman Dental Surgeons, Lahore, Pakistan
Information provided by (Responsible Party):
Wenche S. Borgnakke DDS MPH PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01774942
First received: January 21, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus With Hyperglycemia
Inflammation
Post-osseointegration Mechanical Failure of Dental Implant
Other: All teeth out, full dentures, dental implants, blood draw
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1a) [ Time Frame: Every 3 months/6 months ] [ Designated as safety issue: No ]
    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:
  • high-sensitivity C-reactive protein (hsCRP) [ Time Frame: Every 3 months/6 months ] [ Designated as safety issue: No ]
    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:
  • Retention of implants [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All teeth out, full dentures, dental implants, blood draw Other: 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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774942

Locations
Pakistan
Rahman & Rahman Dental Surgeons
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Wenche S. Borgnakke DDS MPH PhD
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
  More Information

Additional Information:
No publications provided

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
Study First Received: January 21, 2013
Last Updated: January 21, 2013
Health Authority: United States: Institutional Review Board
Pakistan: Research Ethics Committee

Keywords provided by 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
Hyperglycemia
Inflammation
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014