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

This study compares the patterns of dental implant stabilization between a standard and chemically modified implant surface in patients with type 2 diabetes. It is hypothesized that the chemically modified surface will enhance early healing events (first 4 months following placement)in diabetes patients with compromises in rate of implant integration.

• Partially Edentulous Mandible
• Type 2 Diabetes

• Device: dental implant
  standard SLA surface
• Device: modified dental implant
  chemically modified surface

• Active Comparator: dental implant
  standard SLA surface
  Intervention: Device: dental implant
• Experimental: modified dental implant
  chemically modified surface
  Intervention: Device: modified dental implant

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