- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282046
Diabetes Effects on Long-Term Implant Survival and Success
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229-3900
- University of Texas Health Science Center at San Antonio
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
at an anticipated average of 5 years following placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
resonance frequency analysis
Time Frame: at an anticipated average of 5 years following placement
|
implant stability will be measured at 6 month intervals using resonance frequency analysis.
|
at an anticipated average of 5 years following placement
|
Collaborators and Investigators
Investigators
- Principal Investigator: thomas oates, dmd, phd, University of Texas Health Science Ctr a
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-444H
- R01DE023518 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationRecruitingType 2 Diabetes Mellitus With ComplicationIndia