Christoph H F Hämmerle1, Ronald E Jung1, Mariano Sanz1, Stephen Chen1, William C Martin1, Jochen Jackowski1, Carl-Johan Ivanoff1, Luca Cordaro1, Jeffrey Ganeles1, Dieter Weingart1, Jörg Wiltfang1, Michael Gahlert1. 1. Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zurich, Zurich, SwitzerlandDepartment of Periodontology, Universidad Complutense de Madrid, Madrid, SpainBalwyn Periodontic Centre, School of Dental Science, University of Melbourne, Melbourne, AustraliaDepartment of Prosthodontics, College of Dentistry, University of Florida, Gainesville, FL, USADepartment of Oral Surgery and Dental Emergency Care, Faculty of Health, University Witten/Herdecke, Witten, GermanyDepartment of Oral and Maxillofacial Surgery, SU/Mölndal Hospital, Mölndal and the Sahlgrenska Academy, Göteborg University, Mölndal, SwedenDepartment of Periodontology and Prosthodontics, Eastman Dental Hospital, Rome, ItalyFlorida Institute for Periodontics and Dental Implants, Boca Raton, FL, USADepartment of Oral, Maxillo and Facial Plastic Surgery, Center for Implant Dentistry, Klinikum Stuttgart, GermanyDepartment of Oral and Maxillofacial Surgery, University of Schleswig-Holstein, Kiel, GermanyPrivate Dental Clinic, Munich, Germany.
Abstract
OBJECTIVES: To test whether or not transmucosal healing at two-piece implants is as successful as submerged placement regarding crestal bone levels and patient satisfaction. MATERIAL AND METHODS:Adults requiring implants in the anterior maxilla or mandible in regions 21-25, 11-15, 31-35 or 41-45 (WHO) were recruited for this randomized, controlled multi-center clinical trial of a 5-year duration. Randomization was performed at implantation allowing for either submerged or transmucosal healing. Final reconstructions were seated 6 months after implantation. Radiographic interproximal crestal bone levels and peri-implant soft tissue parameters were measured at implant placement (IP) (baseline), 6 and 12 months. Patient satisfaction was assessed by a questionnaire. A two-sided t-test (80% power, significance level α=0.05) was performed on bone-level changes at 6 and 12 months. RESULTS:One hundred and twenty-seven subjects were included in the 12-month analysis (submerged [S]: 52.5%, transmucosal [TM]: 47.2%). From IP to 6 months, the change in the crestal bone level was -0.32 mm (P<0.001) for the S group and -0.29 mm (P<0.001) for the TM group. From IP to 12 months, bone-level changes were statistically significant in both groups (S -0.47 mm, P<0.001; TM -0.48 mm, P<0.001). The mean differences of change in the bone levels between the two groups were not statistically significant at either time point, indicating the equivalence of both procedures. For both groups, very good results were obtained for soft tissue parameters and for patient satisfaction. CONCLUSIONS:Transmucosal healing of two-piece implants is as successful as the submerged healing mode with respect to tissue integration and patient satisfaction within the first 12 months after IP.
RCT Entities:
OBJECTIVES: To test whether or not transmucosal healing at two-piece implants is as successful as submerged placement regarding crestal bone levels and patient satisfaction. MATERIAL AND METHODS: Adults requiring implants in the anterior maxilla or mandible in regions 21-25, 11-15, 31-35 or 41-45 (WHO) were recruited for this randomized, controlled multi-center clinical trial of a 5-year duration. Randomization was performed at implantation allowing for either submerged or transmucosal healing. Final reconstructions were seated 6 months after implantation. Radiographic interproximal crestal bone levels and peri-implant soft tissue parameters were measured at implant placement (IP) (baseline), 6 and 12 months. Patient satisfaction was assessed by a questionnaire. A two-sided t-test (80% power, significance level α=0.05) was performed on bone-level changes at 6 and 12 months. RESULTS: One hundred and twenty-seven subjects were included in the 12-month analysis (submerged [S]: 52.5%, transmucosal [TM]: 47.2%). From IP to 6 months, the change in the crestal bone level was -0.32 mm (P<0.001) for the S group and -0.29 mm (P<0.001) for the TM group. From IP to 12 months, bone-level changes were statistically significant in both groups (S -0.47 mm, P<0.001; TM -0.48 mm, P<0.001). The mean differences of change in the bone levels between the two groups were not statistically significant at either time point, indicating the equivalence of both procedures. For both groups, very good results were obtained for soft tissue parameters and for patient satisfaction. CONCLUSIONS: Transmucosal healing of two-piece implants is as successful as the submerged healing mode with respect to tissue integration and patient satisfaction within the first 12 months after IP.
Authors: Juliana Mattos-Silveira; Isabela Floriano; Fernanda R Ferreira; Maria E F Viganó; M A Frizzo; Alessandra Reyes; Tatiane F Novaes; Caroline M Moriyama; Daniela P Raggio; José C P Imparato; Fausto M Mendes; Mariana M Braga Journal: Trials Date: 2014-11-19 Impact factor: 2.279
Authors: Karl-Ludwig Ackermann; Thomas Barth; Claudio Cacaci; Steffen Kistler; Markus Schlee; Michael Stiller Journal: Int J Implant Dent Date: 2020-04-08