Caroliene Meijndert

62 Chapter 4 the study has a short follow-up of 6 months, and does not describe implant stability, aesthetics or patient-reported outcomes (Caiazzo et al., 2019). Therefore, a full-scale assessment on the performance of the Straumann Bone Level Tapered implant system in healed sites in the maxillary aesthetic area is lacking. The purpose of this one-year, prospective, observational case series was to perform a full-scale assessment of clinical, radiographic, aesthetic and patient-reported outcomes of single bone level tapered implants in healed sites in the maxillary aesthetic zone using the new Straumann implant. Materials and Methods Study design The study was designed as a prospective clinical case series with 30 participants. Recruitment and inclusion of participants in need of single-implant treatment took place at the Department of Oral and Maxillofacial surgery of the University Medical Center Groningen, the Netherlands, from January 2016 until December 2017. The research protocol was approved by the Medical Ethics committee of the UMCG (METc 2015.517). The study was registered in the Dutch trial register (Trial ID: NL8755). Informed consent was signed by all the participants prior to treatment. This manuscript was constructed according to the STROBE guidelines for cohort studies (Von Elm et al., 2014). Participants The inclusion criteria were: − the treatment site is in the anterior maxilla (central incisors, lateral incisors, cuspids and first premolars); − a single tooth diastema (healed unassisted for at least 3 months) with sufficient bone volume for implant placement; − the presence of natural teeth on both sides of the planned implant site; − at least 18 years of age at the time of treatment; − the patient is capable of understanding and giving informed consent. Participants were excluded when there was: − presence of active clinical periodontal disease as expressed by probing pockets − depths ≥4 mm combined with bleeding on probing in the natural dentition other that the affected tooth;