Diabetes Effects on Long-Term Implant Survival and Success

• • 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.