A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols

Inclusion Criteria:

• The patient is 18 years or older.
• Ability to understand and sign the informed consent prior to starting the study.
• Ability and willingness to comply with all study requirements.
• Adequate oral hygiene (defined as an average Modified Sulcus Bleeding Index of 1 or less and an average Modified Plaque Index of 1 or less).
• Must be a bounded edentulous space.
• Adequate bone volume to accommodate the planned endosseous dental implant (e.g. sufficient height such that the implant would not encroach on vital structures such as inferior alveolar nerve, and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration, requiring significant grafting at time of implant placement). The only implant utilized in this protocol will be a 4.0 mm diameter by 11 mm long implant (Fixture OsseoSpeed Astra Tech).

Typically, this will mean space dimensions will be: 6 mm or greater ridge width facial-lingual and > 6 mm in the mesial to distal dimension . If the implant can be placed and only a few screw threads are exposed, grafting is allowed to cover these threads. In the planned occlusal-gingival dimension, there must be at least 7 mm of space from the planned head of the implant to the planned occlusal plane.

• Osteotome use will be allowed but there must be a minimum of 8mm of bone height from the alveolar crest to the floor of the sinus. Maximum sinus lift will be 4 mm.
• Existing teeth are healthy and adequately restored, and desired a fixed restoration on implants.
• Patient has a mutually protected occlusion.
• The patient, if of childbearing potential, had a negative pregnancy test within one week prior to surgery.

Exclusion Criteria:

• Patients who have smoked cigarettes or chewed tobacco within the past year.
• History of alcoholism or drug abuse within the past 5 years. - Severe bruxing or clenching habits
• Untreated periodontitis
• Patients at undue risk for an outpatient surgical procedure
• Presence of residual roots at the implant site- Patients with history of site development (extensive bone augmentation) at the implant site in the past 4 months.
• Placement of implant in an extraction site that had been healing for less than 2 month.
• Presence of local inflammation or mucosal diseases such as lichen planus.
• Uncontrolled diabetes (defined as HA1c > 7.0 percent).
• Current hematologic disorder or chronic use of coumarin (or similar) anti-coagulant therapies.
• History of leukocyte dysfunction and deficiencies
• Metabolic bone disorders
• History of renal failure
• History of liver disease
• Immunocompromised patients having HIV, RA, SLE or other collagen vascular disorders.
• Chronic corticosteroid use.
• Current chemotherapy
• History of use of IV-based bisphosphonates.
• History of radiation treatment to the head or neck
• Patients requiring grafting of bone or mucosal tissue at the time of implant placement which would require submersion of the implant during the healing period.
• Use of any investigational drug or device within the 30 day period immediately prior to implant surgery
• Patients requiring submersion of implants for esthetic reasons.
• Patient requiring ongoing dental treatment in the same quadrant or opposing quadrant during the initial 16 week healing period.