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

NCT ID: NCT01774942

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-01
• Study Completion Date: 2015-08-28

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.

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.

Conditions

Type 2 Diabetes Mellitus With Periodontal Complication; Inflammation; Dental Implant Failed

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Procedure/Surgery

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

All teeth out, full dentures, dental implants, blood draw

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rahman & Rahman Dental Surgeons, Lahore, Pakistan

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Wenche S. Borgnakke DDS MPH PhD

Adjunct Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenche S Borgnakke, DDS MPH PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Amin ur Rahman, BDS MPH Cert

Role: STUDY_DIRECTOR

Rahman & Rahman Dental Surgeons, Lahore, Pakistan

William V Giannobile, DDS MS DMSc

Role: STUDY_CHAIR

University of Michigan

Locations

Rahman & Rahman Dental Surgeons

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

HUM00027142

Identifier Type: OTHER

Identifier Source: secondary_id

#539-2007; #807_2011

Identifier Type: -

Identifier Source: org_study_id