Type 2 Diabetes Mellitus With Periodontal ComplicationNCT01774942
Taking Out All Teeth and Replacing Them With Dentures That Rest on Implants in People With Type 2 Diabetes
A study testing Procedure/Surgery in people with Type 2 Diabetes Mellitus With Periodontal Complication and Inflammation, run by University of Michigan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus With Periodontal Complication, Inflammation, Dental Implant Failed
- What is being tested?
- Procedure/Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2008to 28 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ≤ 6 natural teeth
- inflammatory conditions/diseases other than type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study
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:
Read more
- 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
- Changes in certain inflammation markers seen with insulin resistance and other diseases and conditions more common in people with diabetes
- 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.
Read the detailed description
Part I:
Our hypotheses are that levels of HbA1c and hsCRP will:
- decrease after extraction of all teeth
- not increase after placement of dental implants
- not increase after prosthetic restoration with full dentures anchored on the dental implants.
Part II:
Our hypothesis is that:
- 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
- Being tested
- Procedure/Surgery
- Keywords
- Diabetes Mellitus, C-Reactive Protein, Dental Implants, Single-Tooth, Dental Prosthesis, Implant-Supported
- Medical subject headings
- Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/SurgeryProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Procedure/Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months/6 months
Secondary outcomes (1)
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.
Measured: Every 3 months/6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study start1 Jun 2008
- Primary completion28 Aug 2015
- Study completion28 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Periodontal ComplicationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Rahman & Rahman Dental Surgeons, Lahore, Pakistan
- Responsible party
- Principal investigator, Wenche S. Borgnakke DDS MPH PhD, University of Michigan
- Investigators
- Wenche S Borgnakke, DDS MPH PhD, Principal investigator, University of MichiganAmin ur Rahman, BDS MPH Cert, Study director, Rahman & Rahman Dental Surgeons, Lahore, PakistanWilliam V Giannobile, DDS MS DMSc, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774942
- Sponsor's protocol ID
- #539-2007; #807_2011
- Other IDs
- HUM00027142
- Status last verified
- Nov 2018
- First submitted
- 21 Jan 2013
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extractions and Straumann Dental Implants on Glycemic Control and Inflammatory Markers in Patients With Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT01774942
- Acronym / sponsor ID
- #539-2007; #807_2011
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Rahman & Rahman Dental Surgeons, Lahore, Pakistan
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 28 Aug 2015 (actual)
- Study completion
- 28 Aug 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Changes in certain inflammation markers seen with insulin resistance and other diseases and conditions more common in people with diabetes
- 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:
- decrease after extraction of all teeth
- not increase after placement of dental implants
- not increase after prosthetic restoration with full dentures anchored on the dental implants.
Part II:
Our hypothesis is that:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Procedure/Surgery (Impants/Overdentures) | Experimental | Procedure: Procedure/SurgeryOne-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- ≤ 6 natural teeth
- inflammatory conditions/diseases other than type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure/SurgeryAlso: All teeth out, full dentures, dental implants, blood drawAll 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. | Procedure or surgery | Procedure/Surgery (Impants/Overdentures) |
Primary outcome
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.
1 secondary outcome
high-sensitivity C-reactive protein (hsCRP)
Time frame: Every 3 months/6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenche S Borgnakke, DDS MPH PhD principal investigator
University of Michigan
Amin ur Rahman, BDS MPH Cert study director
Rahman & Rahman Dental Surgeons, Lahore, Pakistan
William V Giannobile, DDS MS DMSc study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery in people with Type 2 Diabetes Mellitus With Periodontal Complication and Inflammation, run by University of Michigan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (HbA1a) (time frame: Every 3 months/6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.