Luigi Guida1,2, Marco Annunziata1,2, Umberto Esposito3, Massimiliano Sirignano3, Paolo Torrisi4, Denis Cecchinato5. 1. Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania "Luigi Vanvitelli", Naples, Italy. 2. Department of Dentistry, Orthopedics and Rehabilitation, University Hospital "Luigi Vanvitelli", Naples, Italy. 3. "A. Cardarelli" Hospital, Naples, Italy. 4. Private Practice, Catania, Italy. 5. Institute "Franci, Padua, Italy.
Abstract
OBJECTIVE: The aim of this multicenter parallel-group randomized controlled trial is to compare 6-mm-short with 11-mm-long implants in the rehabilitation of totally edentulous mandible in a completely comparable clinical situation, from anatomical, surgical, and prosthetic point of view. MATERIAL AND METHODS:Thirty patients were selected in three study centers to receive afixed full-arch mandibular rehabilitation supported by five inter-foraminal implants. Patients were randomly allocated, at the time of surgery, half to the test group (6-mm-long implants) and half to the control group (11-mm-long implants). No bone augmentation procedure was performed. After 3 months, a screw-retained full-arch prosthesis with distal cantilevers was positioned (baseline). Peri-implant marginal bone level change (MBLc), implant and prosthesis survival rate, and biological/technical complications were evaluated after 1 and 3 years. RESULTS:Thirty subjects (150 implants) were evaluated after 1 year and 28 (140 implants) after 3 years. No implant or prosthesis loss occurred. No significant inter-group difference for biological/technical complications was registered. No statistically significant (p > .025) intra-group or inter-group difference in the mean MBLc values was registered. The mean MBLc was 0.01 ± 0.19 mm and -0.04 ± 0.21 mm at 1 year, and -0.10 ± 0.24 mm and 0.02 ± 0.25 mm at 3 years (test and control groups, respectively). CONCLUSIONS: 6-mm-short implants may be a reliable option when used in the rehabilitation of total edentulous mandibles. These results need to be confirmed by longer follow-up data from well-designed randomized controlled clinical trials.
RCT Entities:
OBJECTIVE: The aim of this multicenter parallel-group randomized controlled trial is to compare 6-mm-short with 11-mm-long implants in the rehabilitation of totally edentulous mandible in a completely comparable clinical situation, from anatomical, surgical, and prosthetic point of view. MATERIAL AND METHODS: Thirty patients were selected in three study centers to receive a fixed full-arch mandibular rehabilitation supported by five inter-foraminal implants. Patients were randomly allocated, at the time of surgery, half to the test group (6-mm-long implants) and half to the control group (11-mm-long implants). No bone augmentation procedure was performed. After 3 months, a screw-retained full-arch prosthesis with distal cantilevers was positioned (baseline). Peri-implant marginal bone level change (MBLc), implant and prosthesis survival rate, and biological/technical complications were evaluated after 1 and 3 years. RESULTS: Thirty subjects (150 implants) were evaluated after 1 year and 28 (140 implants) after 3 years. No implant or prosthesis loss occurred. No significant inter-group difference for biological/technical complications was registered. No statistically significant (p > .025) intra-group or inter-group difference in the mean MBLc values was registered. The mean MBLc was 0.01 ± 0.19 mm and -0.04 ± 0.21 mm at 1 year, and -0.10 ± 0.24 mm and 0.02 ± 0.25 mm at 3 years (test and control groups, respectively). CONCLUSIONS: 6-mm-short implants may be a reliable option when used in the rehabilitation of total edentulous mandibles. These results need to be confirmed by longer follow-up data from well-designed randomized controlled clinical trials.