Clinical trial NCT02282046: Diabetes Effects on Long-Term Implant Survival and Success
Official title: Diabetes Effects on Long-Term Implant Survival and Success
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
dental implant
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2014-11-04
Enrollment: 171
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: implant complications
timeFrame: at an anticipated average of 5 years following placement
Secondary outcomes:
measure: resonance frequency analysis
timeFrame: at an anticipated average of 5 years following placement
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center At San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Ctr a
name: thomas oates, dmd, phd
role: PRINCIPAL_INVESTIGATOR
References: