59 3.1 Clinical Evaluation of laser-ablated titanium implant by a linear incision without skin reduction for second stage; 2) a ‘‘U’’ shaped incision for implant placement followed by a 4-mm skin punch with no skin reduction for the second stage; 3) ‘‘S’’ shaped skin incision for stage one with no skin reduction followed by a 4-mm skin punch with minimal skin reduction for the second stage. Single-stage procedures were performed in an identical fashion. 2.2 Implant and Abutment The implant was the laser ablated titanium bone anchored implant system Ponto Biohelix (BHX) (diameter, 4.5 mm; length 3 or 4 mm) (Oticon Medical AB Askim, Sweden). Ponto BHX with premounted abutments of lengths 6, 9, and 12 mm were used for single stage surgeries. Abutment lengths of 6, and 12 mm were used at the second stage surgeries for all other children. 2.3 Follow Up and Review Second-stage surgery for abutment placement occurred following a minimum 3-month period. Reviews then occurred at weeks 1 and 2 and then at 3, 6, 9, and 12 months. Complications, revision rates, skin reactions according to the Holger Classification (26), loss of abutment, implant failures, and abutment level ISQs (Osstell ISQ, Osstell AB, Gothenburg, Sweden) were documented at each review. Holgers more than or equal to two were considered adverse skin reactions. Fixture- and abutment- level ISQs were recorded at each surgical stage and subsequently, only abutment-level ISQs were recorded. Two recordings were taken in perpendicular directions (ISQH and ISQL). 2.4 Statistics All data were analyzed using Stata 16 version 16.1 (StataCorp LLC, TX). Categorical data are presented as n (%) and numeric data are presented as the mean (SD) and range or mean (95% CI). To assess the effect of time from surgery on the ISQ, a mixed effect model was applied, and comparisons were performed using the data from the time of surgery as the baseline. The results are presented as coefficients or means with the appropriate confidence interval, and the level of significance was set at p = 0.01. 3. Results A total of 115 consecutive pediatric patients were implanted with the laser ablated titanium bone anchored implant system. The mean age was 8.8 years, with a slight female predominance (52%). Sixty-one children had bilateral implants and 54 had unilateral implants giving a total of 176 implants (3 mm implants n = 124, 4 mm n = 52). A two-stage implantation was performed in 108 patients (167 implants) whereas a single-stage procedure was performed in seven patients
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