Purpose: To compare the outcome of immediately loaded and one-stage conventionally loaded variable-thread tapered implants in the posterior maxilla. Materials and methods: This study was designed as a split-mouth randomised controlled trial. Twenty-six patients missing teeth bilaterally in the posterior maxilla received three to four implants in each of the posterior sextants. Bone quality was recorded based on Misch criteria (D1-D4) and insertion torque values were measured using a manual wrench. The implants on one side were immediately loaded with a temporary resin fixed partial denture on definitive multi-unit abutments. The implants in the contralateral side received definitive multi-unit abutments according to the one-stage unloaded protocol. Three to 3.5 months following implant placement, the implants were restored with metal-ceramic fixed prostheses. Outcome measures were implant and prosthesis failure rates, complications, and peri-implant bone level changes at 1 year following delivery of the definitive prostheses. Results: Two patients dropped out prior to the delivery of definitive prostheses. Four implants supporting a four-unit immediately loaded prosthesis failed in one patient, 3 months following delivery of the definitive prostheses. None of the conventionally loaded implants or prostheses failed. There were no significant differences in the proportions of implant and prosthesis failures (difference = 4.2%; 95% CI -4.2 to 12.6%; P = 0.999). In the immediately loaded group, four early prosthetic complications occurred during the provisionalization phase (three small resin chippings and one prosthetic screw loosening). No other complications were reported. The difference in the rate of complications between the two interventions was not statistically significant (difference = 16.7%; 95% CI -1.2% to 35.6%; P = 0.125). The 1-year peri-implant marginal bone level changes were evaluated in 23 patients (77 immediately loaded and 76 conventionally loaded implants). On average, patients lost 0.42 mm at the immediately loaded and 0.46 mm at the conventionally loaded implants, the difference being statistically not significant (difference = 0.044 mm; 95% CI -0.27 to 0.18 mm; P = 0.701). Conclusions: Immediate loading of 3- to 4-unit fixed partial prostheses supported by variable-thread implants in the posterior maxilla can yield good and similar 1-year results to one-stage conventionally loaded implants.
Keywords: immediate loading, insertion torque, maxilla, randomised controlled trial, variable thread tapered implant
Conflict-of-interest statement: This study was independently designed by the investigators but was supported by Nobel Biocare Services AG, Kloten, Switzerland (grant number 2010-954) in the form of free surgical kits, implants and prosthetic components. No other financial contribution was received by any of the authors or their institutions. The authors declare that there is no affiliation or any other conflict of interest to the sponsor and that Nobel Biocare did not in any way interfere with the conduct of the trial or the publication of its results.