Prospective multicenter study of marginal bone level and soft tissue health of a one-piece implant after two years.
BACKGROUND
A novel 1-piece implant purported to provide for stable tissue support, immediate function, and immediate placement in extraction sockets has been developed. Stabilization of the marginal bone level over time requires documentation.


OBJECTIVE
The aim of this study was to evaluate marginal bone level differences and soft tissue health between the 1- and 2-year follow-up of a 1-piece implant design.


METHODS
Eighty-two implants, restoring both single teeth and multiple edentulous situations, in 56 consecutively treated patients, were included. Marginal bone level was evaluated on radiographs made at implant insertion, 6-month follow-up, and annually thereafter. At 3-, 6-month, and 1-year follow-ups, presence of plaque and the soft tissue response were evaluated using plaque and bleeding on probing indexes. The papilla index was used to determine papilla size at implant insertion with the provisional restoration in place and at the insertion of the definitive restoration. The change over time in marginal bone level was analyzed with a 1-way analysis of variance (ANOVA) paired design with time as main effect (1 to 2 years) and subjects as block effect (alpha=.05).


RESULTS
One implant failure occurred, resulting in a 98.8% cumulative survival rate (CSR) for the follow-up time of 2 years. The mean (SD) change in bone level between years 1 and 2 was 0.08 mm (1.19) (95% CI-0.30 to 0.46) (P=.68), demonstrating a stable marginal bone level. Normal implant mucosa was noted for approximately 90% of the sites at the 1-year follow-up. The mean (SD) papilla score at placement was 1.3 (0.66) and increased to 1.7 (0.67) at insertion of the definitive prosthesis.


CONCLUSIONS
The stable marginal bone level and soft tissue health observed indicate that the 1-piece implant tested has the ability to preserve both hard and soft tissue. Based on the high implant survival rate and favorable tissue response, the 1-piece implant can be recommended for clinical use.
Finne
Kaj
K
k.finne@kolumbus.fi
Rompen
Eric
E
Toljanic
Joseph
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003737:Dental Cavity Preparation; D003758:Dental Implantation, Endosseous; D015921:Dental Implants; D019250:Dental Implants, Single-Tooth; D017267:Dental Prosthesis Design; D019094:Dental Prosthesis, Implant-Supported; D003830:Denture, Partial, Fixed; D005260:Female; D005500:Follow-Up Studies; D005881:Gingiva / Q000502:physiology*; D006801:Humans; D007568:Jaw / Q000502:physiology*; D008875:Middle Aged; D016348:Osseointegration
D015921:Dental Implants