Despite some progress in statistical analysis, if the reporting of studies represents the actual methodology of the trial, this review has identified important aspects of split-mouth study design and analysis that would benefit from development.
Immediate loading of splinted implant restorations is a growing trend, but limited clinical documentation hampers evidence-based treatment planning for single-tooth applications. This study prospectively evaluated the clinical efficacy of placing implant-supported, single-tooth restorations into immediate, full-occlusal loading. Sixty consecutive patients (intent-to-treat group) with 1 missing tooth between 2 intact teeth were treated with a total of 69 implants. At placement, final impressions were made and implants were provisionalized with nonoccluding prostheses. Definitive prostheses were delivered 2 weeks later. A claim of noninferiority was made with a 95% confidence interval (Mann-Whitney U test) if the success rates between the experimental group and a 97% historical control was > 7%. Standardized radiographs taken at placement and bimonthly intervals were analyzed for crestal bone changes at a type I (alpha) error level of .05; significance levels were not adjusted for multiplicity (Fisher exact tests and Student t tests). Sixteen patients (18 implants) were withdrawn for protocol deviations. The resulting treated-per-protocol group consisted of 44 subjects with 51 implants. Cumulative implant success rates were 98.55% (n = 68/69) for the intent-to-treat group and 98.04% (n = 50/51) for the treated-per-protocol group. There were no significant adverse events or statistically significant differences between the experimental and historical control groups. At 12 months mean crestal bone loss was 1.05 mm, and ranged from 0.38 to 1.5 mm (77%) and 1.6 to 2.69 mm (23%). Immediate full-occlusal loading of single-tooth restorations was safely performed in selected subjects when good primary implant stability and an appropriate occlusal load were achieved.
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