A Randomized Prospective Clinical Trial Comparing Single Tooth Implant 3 Loading Protocols
Condition: Dental Implant
Study type: Interventional

Summary: 
      This is a research study to test the clinical procedure and not the FDA approved medical
      device. This project will screen up to 80 volunteers to enroll 40 active subjects to receive
      a single tooth implant on an anterior (incisor/canine) or pre-molar tooth in the mandible or
      maxilla (no implants will be placed in molar sites). This 3 year research study will examine
      the clinical effects of loading regimens on roughened surfaced implants. The proposed
      research project will measure the changes in mucosal healing and maturation over a three year
      period following implant placement. The proposed research lays the foundation for improved
      health care by providing surgeons and restorative dentists with data for determining the
      relationship between implant healing, loading pattern and bone type. The rationale that
      underlies the investigation is that identification of the influences of timing of load on
      implant stability in varying bone types will allow routine, predictable use of early loading,
      which, in turn, will translate into more rapid health care, and improved psychosocial
      well-being of the patient. If these hypotheses are correct, these results are expected to
      provide evidence based research data to support early loading and immediate loading of single
      implants in sites of adequate bone volume, and density. In addition, it is expected that
      these results will fundamentally advance the field of implant dentistry and bioengineering by
      providing information on the principles of the bone density-mechanical environment-implant
      stability interaction.
    

Detailed description: 
      MATERIALS AND METHODS This longitudinal human clinical trial is designed as a prospective
      study, to measure implant stability with the resonance frequency analyzer (Osstell,
      Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post
      placement. After 16 weeks, a definitive implant abutment will be placed and a final dental
      crown delivered. No further follow-up will be done with the resonance frequency approach.
      However, all subjects will be followed through 3 years post implant placement as described
      for each follow-up visit. The study population consists of subjects at the University of
      Iowa's College of Dentistry. Subjects presenting with one tooth missing in the anterior
      (incisor/canine) or pre-molar regions of the mandible or maxilla with existing teeth that
      were healthy or adequately restored shall be screened based on the inclusion/exclusion
      criteria. The missing tooth is to be replaced with a fixed implant restoration on one
      implant.

      SEQUENCE OF VISITS A. Visit 1: Screening Examination

      Subjects shall be seen for evaluation and for collection of baseline data. Pre-treatment data
      shall be recorded on case report forms. The visit shall include:

        1. Explanation to the patient of the purposes of the study and the planned procedures
           related to the study.

        2. Explanation to the subject of the risks and possible complications of participation in
           the study. Patients shall be notified that inclusion in the study is for the purpose of
           providing implant treatment only and that no provision for other active treatments are
           guaranteed or implied except for care related to the implant aspect of their oral
           cavity. This treatment shall be agreed upon as outlined for their specific case.

      Implant Site Selection: Adequate bone volume is needed to accommodate the planned endosseous
      dental implant. This will mean 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. 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.

      The subject should be notified that inclusion in the study is conditional upon satisfying the
      inclusion and exclusion criteria as seen in Table 1. Only subjects satisfying the
      Inclusion/Exclusion criteria shall be enrolled.

      The dental implant system to be used is the Astra Tech OsseoSpeed Dental Implant System
      (Astra Tech AB, Mölndal Sweden). This is an FDA cleared product under FDA 510k clearance act
      (FDA clearance 4/30/2004). This protocol calls for use of only the 4.0 mm diameter by 11 mm
      long dental implant (OsseoSpeed Aqua platform; Ref Number 24622; Astra Tech AB) in the
      anterior (incisor/canine) or posterior pre-molar regions of the mandible or maxilla. All
      sites must have sound natural or restored teeth/implants Mesial and Distal to the planned
      site of interest (Bounded Edentulous Space or BES). The patient should otherwise have a
      restored stable occlusion that is mutually protected. No implants will be placed in molar
      sites. The implant lengths accepted in the study are 11 mm. Clinical and radiographic
      screening will be used to limit the study to patients with sufficient bone quantity to
      completely encase the implant.

      Upon review of the subject's health history, inclusion/exclusion criteria a screening
      clinical assessment will be made. Existing dental radiographs within the past 6 months shall
      be acceptable. No new radiographs will be made until subject enrollment and obtaining signed
      informed consent. The subject will be given an informed consent for the study and reviewed
      with the clinical study coordinator. Preliminary diagnostic impressions will made (Penta, 3M
      ESPE) and poured in dental stone (Whip Mix Corp., Louisville, KY). Implant subjects may have
      a pre-operative Cone Bean CT imaging study (Galileos; Sirona, Charlotte NC; www.sirona.com)
      made at the College of Dentistry's Department of Oral Maxillofacial Radiology at the
      discretion of the Principal Investigator following diagnostic work-up. Subjects shall be
      either patients of record of the College of Dentistry or shall be enrolled if new to the
      College. Patient records are electronic (WinDent) along with a paper version. Paper-based
      Case Report Forms (CRF) containing subject's medical information will be kept in one central
      file in a locked cabinet in the Dental Clinical Research Center. This data will be kept in a
      secured file accessible only by the PI and the Clinical Coordinator.
    

Intervention name(s): dental implant
Intervention type(s): Device
Intervention description(s): Dental implant stability measured with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 16 weeks post placement.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase IV Post-Market evaluation of three 510K cleared implant products. One type of dental implant was used but clinically loaded with a dental crown at one of three time points, immediate at implant placement, at 6weeks or 12 weeks following implant placement. There are therefore 3 interventions being evaluated.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: dental implant; early loading; traditional loading; anterior; implant stability; Subjects presenting with one tooth missing in the anterior; incisor/canine) or pre-molar regions of the mandible; or maxilla with existing teeth that were healthy; or adequately restored shall be screened.