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

NCT01774942 | Completed

• 2 other identifiers: #539-2007; #807_2011HUM00027142
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 2.Changes in certain inflammation markers seen with insulin resistance and other diseases and conditions more common in people with diabetes
3. 3.Retention of dental implants in people with type 2 diabetes.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• high-sensitivity C-reactive protein (hsCRP)

  Every 3 months/6 months

Other Outcomes (1)

• Retention of implants

  6 years

Study Arms (1)

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.

Procedure: Procedure/Surgery

Interventions

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.

Also known as: All teeth out, full dentures, dental implants, blood draw

Procedure/Surgery (Impants/Overdentures)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Rahman & Rahman Dental Surgeons, Lahore, Pakistan: collaborator

Study Sites (1)

Rahman & Rahman Dental Surgeons

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Inflammation; Diabetes Mellitus

Interventions

Surgical Procedures, Operative; Dental Implants; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Investigative Techniques

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 24, 2013
• Study Start: June 1, 2008
• Primary Completion: August 28, 2015
• Study Completion: August 28, 2015
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)