Materials And Methods of Study


A Prospective 10 Year Study
Documenting Clinical Success Rates of New Dental Implant Designs


Purpose:
Manufacturers of dental implants routinely introduce new implant designs into the marketplace that rely on data from previous designs as evidence of success rates in clinical practice. The purpose of this study is to provide a random sampling that validates whether there are significant variations in success rates with current designs.

Selection of Research Participant Practices:
Dentists known to attend ongoing clinical education in dental implantology and to be active in the treatment of edentulous cases were solicited to enroll as data collecting entities.

Materials and Methods:
Clinicians are free to choose the implant modality they will track and submit. A tracking database file will be provided to each practice. If multiple types of implants will be included in practice data, each implant type must have a separate tracking section in the database. Patient initials, date of birth, recording of smoker/non-smoker status, number of implants placed, whether placed in maxilla or mandible, and implants successfully restored will be recorded.

Patient inclusion criteria:

  1. Edentulous in at least one arch for at least 11 months prior to surgery.
  2. At least 18 years old.
  3. Willing and able to give informed consent.
  4. Willing to participate in the study.
  5. Abundant bone Division A bone must be present in the arch to be restored.
  6. Division A bone is classified as >5mm width, >10 mm height, <30 degrees restorative angulation, crown:implant ratio <1.

Smoking/Non-Smoking Categories:
To be classified as a non-smoker, patient must be tobacco free for at least one year.

Patient Exclusion Criteria:

  1. Patients with uncontrolled diabetes and those on oral or IV bisphosphonates are not eligible for inclusion in the data.
  2. History of alcoholism or drug abuse.
  3. Uncontrolled metabolic disease.
  4. Transplant patient on immunosuppressant therapy.
  5. Uncompensated systemic disease.
  6. Mental illness.
  7. Received radiation therapy to surgical site.
  8. Debilitating TMJ pathosis.
  9. Pregnant.
  10. Prisoner.

Success Criteria:

  1. Implant is immobile clinically.
  2. Undistorted radiograph does not show peri-implant radiolucency.
  3. Vertical bone loss is less than 20%
  4. Individual implant characterized by an absence of persistent pain or infection.
  5. Implant design does not preclude placement of prosthesis acceptable to doctor and patient.

Report of Findings:
Data will be reported to NWIRG annually by December 1st