Study Design and Participants
MH, tissue reduction
This study is a continuation of two previously completed, multicenter randomized controlled trials on a wide-diameter implant's stability, survival, and tolerability. In the previous trial 1, the clinical outcomes of the wide-diameter implant (test) compared with the previous-generation implant (control) loaded 6 weeks after surgery were evaluated at 6 months (Patients were divided into three groups to simplify the interpretation of the following sections: group A, patients who received a control implant that was loaded 6 weeks after surgery; group B, patients who received a test implant that was loaded 6 weeks after surgery; and group C, patients who received a test implant that was loaded 3 weeks after surgery. Groups A and B were compared in the aforementioned trial 1, and groups B and C were compared in trial 2.The current study consisted of one follow-up visit at 10 years after implantation for groups A and B and two additional follow-up visits for group C: at 5 and 10 years after implantation. All follow-up visits were performed at the Radboud university medical center, Nijmegen, the Netherlands. Therefore, only the Dutch patients who completed the original trials (n = 72) were approached for participation in the current study. To be included in the original trials, patients had to have a BAHI indication and be at least 18 years old at the time of implantation (Two BAHI surgeons (EM and MH) performed all operations in our tertiary referral center between April 2009 and July 2010. In all cases, the surgery included a single-stage procedure using the Nijmegen linear incision technique with tissue reduction (All trials followed a similar follow-up scheme. In trial 1, the follow-up visits took place at 10 days, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months, 12 months, 24 months, 36 months, 5 years, and 10 years after implantation. Follow-up visits in trial 2 took place at 10 days, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months, 36 months, 5 years, and 10 years after implantation.