Diabetes Effects on Long-Term Implant Survival and Success

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% controlled diabetic) and 8.0%
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.

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.