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

Inflammation Clinical Trial

Official title:

Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774942
• Other study ID #: #539-2007; #807_2011
• Secondary ID: HUM00027142
• Status: Completed
• Phase: N/A
• Start date: June 1, 2008
• Est. completion date: August 28, 2015

Study information

• Verified date: November 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 28, 2015
• Est. primary completion date: August 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failed
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Type 2 Diabetes Mellitus With Periodontal Complication

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Rahman & Rahman Dental Surgeons	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Rahman & Rahman Dental Surgeons, Lahore, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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

External Links

•   Borgnakke WS, Rahman AU*. Reducing risk: effects on glycemic control and C-reactive protein of full mouth extractions and overdentures supported by Straumann implants. 1st Middle Eas ITI meeting, May 6, 2011. Beirut, Lebanon.
•   Rahman AU et al. Effects of full-mouth extraction restored by Straumann implant-supported overdentures on glycemic control & C-reactive protein level in uncontrolled type 2 diabetes. ITI Symposium, May 4-6, 2017. Basel, Switzerland