Caroliene Meijndert

44 Chapter 3 included a full-scale assessment of bone level change and the effects on soft tissue, aesthetics and patient satisfaction. Therefore, the objectives of this prospective study were to report the clinical, radiographic and aesthetic outcomes, including biological and technical complications, and satisfaction of patients treated with single bone level implant restorations with a conical connection, with a follow-up of 5 years. Materials and Methods Study design The study was designed as a single cohort, prospective clinical case series with a follow- up of 5 years. The manuscript was organized according to the STROBE guidelines. Recruitment of patients , implant treatment and follow-up took place at the Department of Oral and Maxillofacial Surgery of the University Medical Centre Groningen (UMCG), the Netherlands. The Medical Ethical Committee of the UMCG reviewed and approved the study protocol (METC 2009.057). Written informed consent was obtained from all eligible patients before enrolment. Details of the study design and the results of the one year follow-up were described by Santing and colleagues (Santing et al., 2013). Patients Sixty patients (29 males, 31 females; mean age 37 years) matched the inclusion criteria and were enrolled in the study ( Table 1 ). These criteria included a single tooth diastema in the maxillary anterior region which had to be missing for at least 3 months prior to implant placement. Patients who smoked or were periodontally unhealthy (indicated by bleeding on probing combined with pockets ≥4mm) were excluded from the study. These 60 patients had 39 missing central incisors, 10 missing lateral incisors, 5 missing cuspids and 6 missing first premolars. Twenty-nine patients had a large bone defect and were augmented in a separate session before placing an implant. The nature of the defects was mainly horizontal. Autogenous bone grafts for guided bone regeneration (GBR) were harvested from the retromolar ramus area and mixed with spongiosa granules (0.25-1.0 mm, Geistlich Bio- Oss®, Geistlich Pharma AG, Wolhusen, Switzerland). This 1:1 mixture was placed in the defect and a membrane (Geistlich Bio-Gide®, Geistlich Pharma AG) was placed to cover the augmented area. The wound was subsequently sutured with vertical and horizontal