A 5-year prospective multicenter clinical trial of non-submerged dental implants with a titanium plasma-sprayed surface in 200 patients.

BACKGROUND

Endosseous dental implants are a popular treatment to replace missing teeth. Although many advances have occurred and affected the macrogeometry and surface characteristics of dental implants, among other aspects, it is important to document how the implants perform in patients over time. Such evaluations are helpful not only to document the clinical survival of the implants but also patient satisfaction over an extended period.

METHODS

A formal prospective multicenter human clinical was performed at five centers involving 200 patients and 626 implants. Specific inclusion and exclusion criteria were used and detailed data collected at specified times using case report forms. An independent study monitor reviewed all study data before entry into the study database. Two implant designs were used in two different clinical indications. A non-submerged titanium plasma-sprayed (TPS) hollow cylindrical implant with a smooth transgingival collar was evaluated in the maxillary anterior sextant and a non-submerged TPS solid screw implant with similar collar in the mandible.

RESULTS

Over the course of the 5-year clinical trial, there was one early failure occurring before definitive prosthesis delivery. Three late failures were documented, one occurring at each of the 6, 12, and 18 months postoperative visits. Life table analysis at 5 years revealed a 99.4% survival rate and a 92.5% success rate. Patient satisfaction was rated as good to excellent for 96.1% of implants in regards to esthetics after 5 years; 98.8% for appearance; and 99.4% for prosthesis comfort, ability to chew and taste, fit, and general satisfaction. No serious adverse events were reported.

CONCLUSIONS

Implant success and survival was over 92% and 99%, respectively, in a formal 5-year prospective multicenter clinical trial involving 200 patients and 626 non-submerged TPS implants. These implants included hollow cylinder implants in the anterior maxilla and solid screw implants placed in the mandible. These findings document the predictability and patient satisfaction of tooth replacement using a non-submerged surgical technique involving a tissue-level, rough surfaced endosseous dental implant.