Objectives: This randomised, controlled multicentre trial aimed at comparing two versions of a variable-thread dental implant design to a standard tapered dental implant design in cases of immediate functional loading for 36 months after loading.
Materials and methods: 177 patients (325 implants) were included at 12 study centres and randomly allocated into one of three treatment groups: NAI (variable-thread design, NobelActive internal connection), NAE (variable-thread design, NobelActive external connection) and, as control, NR (standard tapered design, NobelReplace tapered groovy). Inclusion criteria concerned healed bony implant sites and feasibility for immediate loading. Clinical and radiographic examinations were performed at implant placement and after 3, 6, 12, 24 and 36 months. The outcome measures were marginal bone remodelling (primary outcome), implant survival and success, papilla score, plaque accumulation, and bleeding on probing.
Results: 127 patients (NAI: 45, NAE: 41, NR: 41) were followed-up and evaluated after 36 months. No significant differences in cumulative survival rates were seen for the groups (NAI: 95.7%; NAE: 96.3%; NR: 96.6%). In all groups, bone remodelling occurred during the first 3 months, with stable or even increasing bone levels after the initial remodelling period. The bone remodelling from insertion to 36 months for the NAI group (-0.89 ± 1.65 mm) was comparable (P = 0.98) to that of the NR group (-0.85 ± 1.32 mm). The NAE group showed comparable bone remodelling during the first year, with an increase in following years resulting in significantly less overall bone loss (-0.16 ± 1.06 mm) (P = 0.041). Overall improvement in papilla size was observed in all treatment groups.
Conclusions: Over 36 months, the results show stable or improving bone levels for all treatment groups after the initial bone remodelling seen during the first 3 months after placement. The variable- thread implants showed results comparable to those of standard tapered implants in cases of immediate function, and therefore can be considered as a treatment option for immediate loading.
Trial registration: ClinicalTrials.gov NCT01397617.