Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
Condition: Partial Edentulism
Intervention: SLActive dental implant
Intervention description: Straumann® SLActive implants will be placed. Implants in Arm 1 will be restored with a temporary restoration on the day of surgery.
Implants in Arm 2 will receive healing caps immediately after surgery and a provisional restoration will be placed between day 28 to day 34 post-surgery.
In both arms, the final restoration will be placed between 140 and 160 days (20 to 23 weeks) post-surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dental implants

Summary:

      The purpose of this study is to evaluate the performance of a new dental implant with a
      modified surface in different loading protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females must be at least 18 years of age

          -  Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA
             positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.)

          -  Subjects desire an implant supported restoration on1 to 4 implants per quadrant

          -  The tooth/teeth position(s) at the proposed implant site must have been extracted or
             lost at least 4 months before the date of implantation and be fully healed

          -  Adequate bone quality and quantity at the implant site to permit the insertion of a
             Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of
             concurrent bone augmentation techniques. If more bone is available and is indicated a
             Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length
             may be used, 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 of bone lingual and buccal bone will remain

          -  The opposing dentition must be natural teeth or fixed crowns or bridges on natural
             teeth or implants. Removable prostheses or dentures opposing the study implants are
             not allowed

          -  Patients must be committed to the study for its full duration.

        Exclusion Criteria:

          -  Presence of conditions requiring chronic routine prophylactic use of antibiotics
             (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular
             anomalies, prosthetic joint replacements)

          -  Medical conditions requiring prolonged use of steroids

          -  History of leukocyte dysfunction and deficiencies

          -  History of bleeding disorders

          -  History of neoplastic disease requiring the use of chemotherapy

          -  History of radiation therapy to the head and neck

          -  Patients with history of renal failure

          -  Patients with severe or uncontrolled metabolic bone disorders

          -  Uncontrolled endocrine 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

          -  Alcoholism or drug abuse

          -  Patients infected with HIV

          -  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, or unreliability

          -  Local inflammation, including untreated periodontitis

          -  Mucosal diseases such as erosive lichen planus

          -  History of local irradiation therapy

          -  Presence of osseous lesions

          -  Unhealed extraction sites (less than 4 months post extraction of teeth in intended
             sites)

          -  Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement)
             prior to implant placement unless performed more than 6 months prior to implant
             placement and the site fully healed. Note: Minor bone enhancement using harvested bone
             from the implant site and a resorbable membrane is allowed at the time of implant
             placement

          -  Patients requiring bone grafting at the surgical sites at the time of surgery.

          -  Severe bruxing or clenching habits

          -  Persistent intraoral infection

          -  Lack of primary stability of one (or more) implant(s) at surgery. In this instance the
             patient must be withdrawn and the patient treated accordingly

          -  Patients with inadequate oral hygiene or unmotivated for adequate home care