Type 2 Diabetes MellitusNCT02282046
Diabetes Effects on Long-Term Implant Survival and Success
An observational study of Type 2 Diabetes Mellitus, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study is designed to understand the impact of glycemic control in patients with type 2 diabetes on dental implants under long-term function. It is hypothesized that poor glycemic control will not have significant effects on implant-related outcomes over longer periods of time. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 5 Sep 2018
- Phase
- Observational
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will include those edentulous patients benefiting from mandibular implant overdenture support. It may include those already being followed in a similar study or patients newly receiving dental implants. It will also include type 2 diabetes patients who received dental implant therapy as part of a previous study on the impact of glycemic control.
Who may be able to join
- • Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- For participants with existing implant therapy: participated in either of two previous observational diabetes-implant studies that monitored implant outcomes and glycemic levels as conducted by Dr. Oates [IRB study #s: HSC20070499H \& HSC20080156H].
- For edentulous participants without existing implant therapy: Diagnosis of type 2 diabetes mellitus occurring more than 1 year prior to enrollment (self-reported and verified with physician report, test results, and/or treatment record) or healthy, non-diabetic with a HbA1c < 6.0%, or either FPG < 100 mg/dl or an OGTT < 140 mg/dl (2 hr) within 11 months prior to surgery; participants must have complete maxillary and mandibular dentures determined to be clinically acceptable by study dentists; and must have an identified need for 2-implant supported mandibular overdenture using standard diameter Straumann 4.1 mm implants.
- Male or female, aged 25 to 99.
- HbA1c <12%.
- Women of reproductive potential must report a negative urine pregnancy test within 2 weeks of enrollment in study, and agree to use highly effective contraception during study period. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms.
Who cannot join
- Medical condition, laboratory finding, or physical exam finding that precludes implant placement or therapy (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
- Current medications or history of treatment known to have an effect on bone turnover, including: calcitonin, systemic steroids, bisphosphonates, estrogen or progesterone therapy.
- Presence of acute untreated oral infections or inflammatory lesions.
- History of HIV infection, Hepatitis B or C as determined by patient report or medical record.
- Self-reported history of illicit drug use or alcohol abuse (Appendix D).
- Implant site has had bone grafting procedures using autogenic or allogenic materials less than one year prior to placement, or requires bone grafting in conjunction with implant placement.
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- Implant site has had alloplastic grafting procedures.
- Presence of a disease that affects bone metabolism, such as but not limited to: hyperthyroidism, hyperparathyroidism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease.
- Participation in a clinical study that may interfere with participation in this study during the implant surgical phase and healing 4 months following placement.
- Self-reported current tobacco use
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center At San Antonio
San Antonio, Texas, 78229-3900
About this study
This study is designed to understand the impact of glycemic control in patients with type 2 diabetes on dental implants under long-term function. It is hypothesized that poor glycemic control will not have significant effects on implant-related outcomes over longer periods of time.
Read the detailed description
This single-center prospective observational cohort study seeks to clarify the role of glycemic control as a risk determinant for survival of dental implants and biologic complications of dental implant therapy in patients with type 2 diabetes. Long-term implant stability and implant-related complications will be assessed in relation to glycated hemoglobin levels over time in poorly-controlled and well-controlled diabetics and in non-diabetic participants.
Primary: To determine the impact of glycemic control in type 2 diabetes patients on implant-related biologic complications, integration and survival for dental implants under long-term functional loading (>1 year).
Secondary: To examine these associations relative to long-term effects of sub-optimal glycemic control on two different anatomic/restorative schemes (fixed partial or removable complete) Outcomes: Assessments include implant survival, implant-related biologic complications and resonance frequency analysis as a measure of implant stabilization. Outcomes will be analyzed relative to glycated hemoglobin levels (HbA1c) taken at 6-month intervals over the course of the study.
The total study population will consist of 163 participants who will be followed for at least 2 years. This will include enrolling from a group of 141 patients who have previously received implant therapy as part of short-term assessments regarding diabetes.
In addition, the study plans to enroll 42 participants who would benefit from implant supported denture therapy as done in the prior studies. These participants will be classified into 3 separate groups depending on the A1C reading at time of implant placement. The criteria being followed for the groups are HbA1c< 6.0% (non-diabetic), 6.0%<HbA1c<8.0% (well controlled diabetic) and 8.0%<HbA1c<12.0% (poorly controlled diabetic).
A review of the potential participant's health is completed at the time of screening. The implant surgeon will determine if a patient is healthy for surgery with no anticipated health complications. If a health concern is evident that precludes implant placement, the patient will be excluded from study participation.
The age requirement for the study is 25 years of age or older. It is expected that most participants will be 50 years and over due to the specific clinical requirements for the treatment being followed. Individuals of any gender, race, and ethnicity may participate in this study. Most patients live locally in San Antonio, TX and some are from the surrounding cities.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, dental implant
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-diabetic group | patients without diagnosed type 2 diabetes, having an HbA1c level below 6.0% | |
| type 2 diabetes group | patients diagnosed with type 2 diabetes of over 1 year duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant complications
long-term clinical evaluations will be performed every 6 months.
biologic complications assessed will include signs of infection, inflammation, bone loss, and implant failure.
Measured: at an anticipated average of 5 years following placement
Secondary outcomes (1)
resonance frequency analysis
implant stability will be measured at 6 month intervals using resonance frequency analysis.
Measured: at an anticipated average of 5 years following placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startMay 2014
- Primary completion15 May 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- thomas oates, dmd, phd, Principal investigator, University of Texas Health Science Ctr a
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282046
- Sponsor's protocol ID
- 13-444H
- Other IDs
- R01DE023518
- Status last verified
- Jan 2020
- First submitted
- 15 Sep 2014
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Effects on Long-Term Implant Survival and Success
- ClinicalTrials.gov ID
- NCT02282046
- Acronym / sponsor ID
- 13-444H
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, dental implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- May 2014
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 4 Nov 2014 (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.
This study is designed to understand the impact of glycemic control in patients with type 2 diabetes on dental implants under long-term function. It is hypothesized that poor glycemic control will not have significant effects on implant-related outcomes over longer periods of time.
Detailed description
This single-center prospective observational cohort study seeks to clarify the role of glycemic control as a risk determinant for survival of dental implants and biologic complications of dental implant therapy in patients with type 2 diabetes. Long-term implant stability and implant-related complications will be assessed in relation to glycated hemoglobin levels over time in poorly-controlled and well-controlled diabetics and in non-diabetic participants.
Primary: To determine the impact of glycemic control in type 2 diabetes patients on implant-related biologic complications, integration and survival for dental implants under long-term functional loading (>1 year).
Secondary: To examine these associations relative to long-term effects of sub-optimal glycemic control on two different anatomic/restorative schemes (fixed partial or removable complete) Outcomes: Assessments include implant survival, implant-related biologic complications and resonance frequency analysis as a measure of implant stabilization. Outcomes will be analyzed relative to glycated hemoglobin levels (HbA1c) taken at 6-month intervals over the course of the study.
The total study population will consist of 163 participants who will be followed for at least 2 years. This will include enrolling from a group of 141 patients who have previously received implant therapy as part of short-term assessments regarding diabetes.
In addition, the study plans to enroll 42 participants who would benefit from implant supported denture therapy as done in the prior studies. These participants will be classified into 3 separate groups depending on the A1C reading at time of implant placement. The criteria being followed for the groups are HbA1c< 6.0% (non-diabetic), 6.0%<HbA1c<8.0% (well controlled diabetic) and 8.0%<HbA1c<12.0% (poorly controlled diabetic).
A review of the potential participant's health is completed at the time of screening. The implant surgeon will determine if a patient is healthy for surgery with no anticipated health complications. If a health concern is evident that precludes implant placement, the patient will be excluded from study participation.
The age requirement for the study is 25 years of age or older. It is expected that most participants will be 50 years and over due to the specific clinical requirements for the treatment being followed. Individuals of any gender, race, and ethnicity may participate in this study. Most patients live locally in San Antonio, TX and some are from the surrounding cities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-diabetic group | – | –patients without diagnosed type 2 diabetes, having an HbA1c level below 6.0% |
| type 2 diabetes group | – | –patients diagnosed with type 2 diabetes of over 1 year duration. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will include those edentulous patients benefiting from mandibular implant overdenture support. It may include those already being followed in a similar study or patients newly receiving dental implants. It will also include type 2 diabetes patients who received dental implant therapy as part of a previous study on the impact of glycemic control.
Key inclusion criteria (7 listed)
- • Provide signed and dated informed consent form.
Key exclusion criteria (11 listed)
- Medical condition, laboratory finding, or physical exam finding that precludes implant placement or therapy (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
implant complications
Time frame: at an anticipated average of 5 years following placement
long-term clinical evaluations will be performed every 6 months. biologic complications assessed will include signs of infection, inflammation, bone loss, and implant failure.
1 secondary outcome
resonance frequency analysis
Time frame: at an anticipated average of 5 years following placement
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 21 Jan 2020.
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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.
thomas oates, dmd, phd principal investigator
University of Texas Health Science Ctr a
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 7 inclusion and 11 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 21 Jan 2020. 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 United States. 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?
implant complications (time frame: at an anticipated average of 5 years following placement). 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 21 Jan 2020.