Type 2 Diabetes Mellitus Clinical Trial
Official title:
Diabetes Effects on Long-Term Implant Survival and Success
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|