Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes

This is a prospective randomized study design whereby type 2 diabetic patients will receive 2
implants in the mandible or maxilla to assess implant integration. One implant will be a
regular SLA implant; the other will have a SLActive surface. The primary objective of this
randomized controlled study is to evaluate the stability of Straumann 4.1 mm diameter
implants in the posterior mandible or maxilla of type 2 diabetic patients during the first 12
weeks after implantation using resonance frequency analysis. The control implant is a
standard Straumann implant with an SLA® surface and the test implant the same implant design
with SLActive® surface. Assessments will utilize resonance frequency analysis (RFA), as a
measure of implant integration, and clinical outcomes of implant success. This study will
enroll type 2 diabetes patients having glycated hemoglobin (HbA1c) levels from 8.0% to 12% at
baseline.

The primary objective is to test for statistically significant differences in ISQ values
between the test and control implants at 2, 3, 4, 6, 7, 8 weeks and 3 months after surgery.
If a difference of 2 Osstell RFA ISQ units is detected at any time point it will be
considered that the implant having achieved the higher value is better osseointegrated. This
split-mouth study design will assess changes in implant stability from baseline as the
primary outcome at the implant level. This study will require 20 patients to detect this
difference (SD=2.0 ISQ units) with a power of 80% at the P=0.05 level.

Secondary objectives include:

- Implant survival and implant success at 1-year post loading.

- The nature and frequency of adverse events/complications between the 2 groups will be
compared.

- Prosthesis success

Inclusion Criteria:

- Males and females must be at least 18 years of age, and having a diagnosis of type 2
diabetes mellitus occurring over 1 year prior to enrollment (self-reported and
verified with physician report, test results, and/or treatment record)

- Type 2 diabetic patients may be on a modified diet, oral medication, insulin, or
combination therapies

- Glycated hemoglobin A1c (HbA1c) levels of at least 8.0% up to and including 12.0% as
reported within 4 weeks of implant placement

- Have at least two missing teeth in the posterior mandible in FDI positions 4, 5, 6, or
7

- The tooth at the implant site must have been extracted or lost at least 4 months
before the date of implantation

- Adequate bone quantity at the implant site to permit the insertion of a Straumann
Standard or Standard Plus 4.1 mm diameter implant at least 8 mm in length without the
use of concurrent bone augmentation techniques, i.e. Implant insertion sites must have
sufficient bone height such that the implant will not encroach on vital structures and
sufficient width that a minimum of 1 mm lingual and buccal bone will remain

- Patients must have signed the informed consent form. They must be committed to the
study. If the treating clinicians doubt that the patient is willing or will be able to
attend all study follow-up visits then the patient should not be admitted to the study

Exclusion Criteria:

- Patients with a history of systemic disease other than type 2 diabetes mellitus that
may preclude dental implant therapy (including cardiovascular, hepatic, renal,
gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or
psychiatric disorders)

- Presence of conditions requiring chronic routine prophylactic use of antibiotics
(e.g., bacterial endocarditis, cardiac valvular anomalies, prosthetic joint
replacements)

- Diabetic retinopathy requiring imminent or planned surgical intervention

- Diabetic neuropathy of sufficient severity as to require treatment for control of
symptoms

- Serum creatinine > 1.6 mg/dl

- AST (SGOT) or ALT (AGPT) > 2 times upper limit of normal laboratory range

- Hypertension, with or without medications, having a systolic pressure > 185mm Hg or
diastolic pressure > 105mm Hg

- Patient has significant untreated oral infections or inflammatory lesions

- Medical conditions requiring prolonged use of steroids

- History of leukocyte dysfunction and deficiencies

- History of bleeding disorders

- Patients with history of renal failure

- Patients with metabolic bone disorders

- Physical handicaps that would interfere with the ability to perform adequate oral
hygiene

- Use of any investigational drug or device within the 30 day period immediately prior
to implant surgery on study day 0

- Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco

- Conditions or circumstances, in the opinion of the investigator, which would prevent
completion of study participation or interfere with analysis of study results, such as
history of non-compliance, unreliability

Local Factors:

- Signs of oral inflammation, such as untreated periodontitis around the teeth or
erosive lichen planus in the non-tooth associated areas

- History of head/neck irradiation therapy

- Presence of bone defects in the jaw preventing implant placement

- Unhealed extraction sites (less than 4 months post extraction of teeth in intended
sites)

- Bone surgery (bone grafts, guided tissue regeneration technique for bone enhancement)
less than 6 months prior to implant placement

- Patients requiring bone grafting at the surgical sites at the time of surgery

- Severe teeth grinding or clenching habits

- Persistent intraoral infection

- Lack of sufficient stability of the implant at surgery to allow for proper healing.

- Patients with inadequate oral hygiene or unmotivated for adequate home care