Dataset Information

A novel fully tapered, self-cutting tissue-level implant: non-inferiority study in minipigs.

ABSTRACT:

Objectives

To assess the osseointegration and crestal bone level maintenance of a novel fully tapered self-cutting tissue-level implant for immediate placement (test) compared to a clinically established tissue-level implant (control) in moderate bone quality.

Materials and methods

Test and control implants were compared in 3 groups, i.e., small-, medium-, and large-diameter implants in an edentulous mandibular minipig model with moderate bone quality after 12 weeks of healing. Histometrically derived bone-to-implant contact (BIC) and first bone-to-implant contact (fBIC) were subjected to statistical non-inferiority testing. Maximum insertion torque values in artificial bone were assessed for comparison.

Results

BIC values for the tests and control implants for all 3 diameters were comparable and non-inferior: small diameter (61.30 ± 10.63% vs. 54.46 ± 18.31%) (p=0.99), medium diameter (60.91 ± 14.42 vs. 54.68 ± 9.16) (p=0.55), and large diameter (45.60 ± 14.67 vs. 52.52 ± 14.76) (p=0.31). fBIC values for test implants were higher and non-inferior compared to control implants in all three groups. Test implants further showed distinctly higher maximum insertion torque values compared to control implants.

Conclusion

The investigated novel tissue-level implant is able to achieve high levels of primary and secondary implant stability under simultaneous preservation of crestal bone levels. This qualifies the studied implant as an attractive candidate for immediate placement in bone of limited quality.

Clinical relevance

This pilot pre-clinical study investigated a novel tissue-level implant for immediate placement. With the aim of translating the studied prototype into clinical application pre-clinical models, procedures and controls have been chosen with the aim of reflecting its future clinical indication and use.

SUBMITTER: El Chaar E

PROVIDER: S-EPMC8531107 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Immediate function has become an accepted treatment modality for fixed restorations in completely edentulous jaws. It is known that implant microtopography (surface) may enhance osseointegration, while implant macrotopography (macrodesign) plays an important role in primary stability in the patient requiring an immediate loading. The aim of this retrospective study was to evaluate the clinical and radiographic outcomes of the edentulous subjects treated with narrow and/or regular diameter, which placed and loaded immediately. METHODS:Forty-two consecutive patients received 171 implants, including regular and narrow diameter implants (NDIs). Each jaw, 19 mandibles and 24 maxillae, was treated with a fixed-full arch prosthesis according to the Straumann® Pro Arch concept. The majority (95%) of the restorations were supported by four implants, of which the posterior two implants were tilted. A provisional functional acrylic prosthesis was delivered on the day of surgery. All patients were followed up to 55?months. Cumulative survival rate was determined using Kaplan-Meier analysis. Radiological measurement of marginal bone level was performed. RESULTS:The overall follow-up time for survival rate was up to 55?months. Four implants (3 implants in maxilla, 1 implant in mandible) were lost, resulting in an overall cumulative implant survival rate of 97.7%. Implant survival rate in the axial and tilted implants was not statistically significant. The mean of interproximal marginal bone loss was 0.15?mm after 24?months. Good soft tissue health was observed in almost 99% of patients. The final prosthesis survival rate was 100%. CONCLUSIONS:The results of this retrospective pilot study indicated that total edentulous patients requiring an immediate implant placement and loading can be successfully treated with this implant design. The improved mechanical properties of these implants might give a more conservative treatment option for the jaws showing a severe horizontal alveolar bone resorption.