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Prospective randomized controlled clinical study comparing two dental implant systems: demographic and radiographic results at one year of loading
Author(s) -
Thoma Daniel S.,
Sanz Martin Ignacio,
Benic Goran I.,
Roos Malgorzata,
Hämmerle Christoph H. F.
Publication year - 2014
Publication title -
clinical oral implants research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.407
H-Index - 161
eISSN - 1600-0501
pISSN - 0905-7161
DOI - 10.1111/clr.12120
Subject(s) - dentistry , medicine , radiography , dental implant , implant , randomized controlled trial , orthodontics , prospective cohort study , surgery
Objective To compare the clinical and radiographic outcomes of implants and implant‐supported reconstructions using a 1‐piece ( STM ) and a 2‐piece ( BRA ) dental implant system. Material and methods Sixty patients were randomly assigned to receive STM or BRA implants. The implants restored with fixed or removable prostheses. Baseline measurements (day of loading) and 1‐year measurements included demographic and radiological parameters with details of the surgical procedures, type of prosthesis, survival of implants, and marginal bone‐level changes. The Mann–Whitney U ‐test and the paired t ‐test were used to analyze the data between the two groups and within the groups within 1 year on an implant‐ and patient‐based level. Results In all 60 patients, implants were placed and supported 65 final reconstructions (33 BRA , 32 STM ). One implant was lost in the STM group at 9 months (98.5% survival rate), none were lost in the BRA group (100%). On the implant level, the median marginal bone levels were −1.02 mm (interquartile range ( IQR ) 0.41 mm) at baseline and −1.08 mm (0.59 mm) 1 year later ( BRA ) and −0.51 mm (0.93 mm) and −0.75 mm (1.14 mm) ( STM ). The patient level values were −0.98 mm (0.47 mm) at baseline and −1.10 mm (0.71 mm) 1 year later ( BRA ) and −0.43 mm (0.59 mm) and −0.71 mm (0.97 mm) ( STM ). The differences between the two groups at both time‐points were statistically significant in the patient‐level analysis with higher bone levels for the STM group ( P < 0.05). The changes in mean marginal bone levels on the implant level amounted to −0.05 mm ( SD ±0.32 mm) ( BRA ) and to −0.27 mm (±0.52 mm) ( STM ). Patient‐level values were −0.06 mm (± 0.37 mm) ( BRA ) and −0.25 mm (±0.35 mm) ( STM ). These differences between the groups reached statistical significance on the patient level with less bone loss in the BRA group ( P < 0.05). Conclusions Within the first year of functional loading, high survival rates and minimal changes of marginal bone levels were found for both implant systems used.