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Randomized Controlled Trial
. 2014 Jul 30:4:5877.
doi: 10.1038/srep05877.

Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials

Angelo Troedhan  1 , Izabela Schlichting  2 , Andreas Kurrek  3 , Marcel Wainwright  4
Affiliations
Randomized Controlled Trial

Primary implant stability in augmented sinuslift-sites after completed bone regeneration: a randomized controlled clinical study comparing four subantrally inserted biomaterials

Angelo Troedhan et al. Sci Rep. .

Abstract

Implant-Insertion-Torque-Value (ITV) proved to be a significant clinical parameter to predict long term implant success-rates and to decide upon immediate loading. The study evaluated ITVs, when four different and commonly used biomaterials were used in sinuslift-procedures compared to natural subantral bone in two-stage-implant-procedures. The tHUCSL-INTRALIFT-method was chosen for sinuslifting in 155 sinuslift-sites for its minimal invasive transcrestal approach and scalable augmentation volume. Four different biomaterials were inserted randomly (easy-graft CRYSTAL n = 38, easy-graft CLASSIC n = 41, NanoBone n = 42, BioOss n = 34), 2 ccm in each case. After a mean healing period of 8,92 months uniform tapered screw Q2-implants were inserted and Drill-Torque-Values (DTV) and ITV were recorded and compared to a group of 36 subantral sites without need of sinuslifting. DTV/ITV were processed for statistics by ANOVA-tests. Mean DTV/ITV obtained in Ncm were: Control Group 10,2/22,2, Bio-Oss 12,7/26,2, NanoBone 17,5/33,3, easy-graft CLASSIC 20,3/45,9, easy-graft CRYSTAL 23,8/56,6 Ncm, significance-level of differences throughout p < 0,05. Within the limits of this study the results suggest self-hardening solid-block-like bone-graft-materials to achieve significantly better DTV/ITV than loose granulate biomaterials for its suspected improvement of vascularization and mineralization of the subantral scaffold by full immobilization of the augmentation site towards pressure changes in the human sinus at normal breathing.

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Conflict of interest statement

The presented study was conducted without any exterior funding as part of routine patient treatment by all authors. Surgery-documentation were not specially altered for the presented study compared to routine patient treatment in the authors' clinics.DrDr Troedhan A, Dr Schlichting I, Dr Kurrek A and Dr Wainwright M declare no conflicts of interests by monetary funding or compensation of their research by Satelec-ACTEON (Piezo-devices), TRINON-Karlsruhe-GmbH (Implant-system), Geistlich (BioOss), ArtOss (NanoBone), SUNSTAR-Degradable (easy-graft), personal funding or dependencies by and from the above mentioned companies or any kind of benefitial remuneration in cash, stocks or stock options or equities.All devices used in this study were regularly purchased from national dental suppliers and are owned by the authors, as well as the used dental-implants and biomaterials as the same implants and biomaterials among other brands are used in the clinical routine of the authors' clinics in all indications for bone-augmentation and implant insertion since 2001 (DrDr Troedhan A, Dr Kurrek A) and 2004 for Dr Schlichting I and Dr Wainwright M.DrDr Troedhan A, Dr Kurrek A and Dr Wainwright M - forming the independent “TKW-Research-Group” - hold a non-remunerated co-inventorship on the patent filed for the ultrasonic surgical tool-tips for the Intralift-sinuslift and are supported by Satelec-ACTEON in prototyping and manufacturing new Piezotome-applicator-tips designed by these three authors since Satelec-ACTEON discloses revelation of exact specifications on metal/resin-alloys and oscillation-induction for their ultrasonic surgical devices. In case of invitations of DrDr Troedhan A, Dr Schlichting I, Dr Kurrek A and Dr Wainwright M by Universities, educational institutions or organizers of hands-on workshops for qualified dentists' training in cooperation with one of the above mentioned companies, travel-expenses, accommodation and daily diets, regulated by Austrian and German law, are remunerated.Dr Kurrek A was a non-remunerated chief-medical advisor in the development of the Q-implant-system from 1997–1999 and Dr Kurrek A and Dr Troedhan A lead international implantology-courses as visiting Professors at the Health Science University Vientiane/Laos, Faculty of Dentistry in cooperation with TRINON GmbH.

Figures

Figure 1
Figure 1
tHUCSL-INTRALIFT surgical protocol for Piezotome II/SOLO/Implant Center II: minimal invasive crestal flap (A), opening of the bony antral floor with the diamond coated ultrasonic tip “TKW 2” (B), preparation of the receptacle with the diamond coated ultrasonic tip “TKW 4” (C), tight-fit insertion of the ultrasonic detachment tip “TKW 5” and hydrodynamic ultrasonic detachment of the sinus-membrane utilizing the ultrasonic cavitation effect (D), subantral application of 2 ccm biomaterial and marking the osteotomy-site with medical ink (E), Drill-Torque-measurement after mean healing period of 8,92 months at original osteotomy-site marked with medical ink (F), Implant-Insertion-Torque-measurement (G).
Figure 2
Figure 2. Clinical depiction of a typical transcrestal osteotomy.
Site is marked with a medical marker after subantral augmentation with biomaterial for precise location of later ITV/DTV-measurements (A) and after wound-closure (B).
Figure 3
Figure 3. Typical clinical case.
a) presurgical x-ray, b) post-surgical x-ray after tHUCSL-INTRALIFT, the transcrestal osteotomy site is marked with a white arrow, c) intrasurgical x-ray with implant in site after ITV/DTV determination, d) post-surgical x-ray after implant insertion.
Figure 4
Figure 4. Various cases of the control group with implants inserted in natural subantral bone.
Implants used for determination of DTV/ITV are marked with bluish rectangles.
Figure 5
Figure 5. Drill-Torque notched box plot: depicts the interquartile range (IQR) between the 25th and 75th percentile of the specific biomaterial tested where 50% of the data points were located.
Additionally, the upper whiskers represent data within the 75th percentile +1.5 times the IQR. The lower whisker delimits data of the 25th percentile – 1.5 times the IQR. Circles [formula image] represent the outliers. Within the boxes the notches mark the confidence interval based on the median +/− 1.58 (IQR/sqrt of n) [n = number of measurements]. Additionally, the mean value is indicated by a black square [formula image] and the cross symbol [+] displays the standard deviation. Bio-Oss (n = 34), NanoBone (n = 42), easy-graft CLASSIC (n = 41), easy-graft CRYSTAL (n = 38), Control Group (n = 36).
Figure 6
Figure 6. Implant-Insertion-Torque notched box plot: depicts the interquartile range (IQR) between the 25th and 75th percentile of the specific biomaterial tested where 50% of the data points were located.
Additionally, the upper whiskers represent data within the 75th percentile +1.5 times the IQR. The lower whisker delimits data of the 25th percentile – 1.5 times the IQR. Circles [formula image] represent the outliers. Within the boxes the notches mark the confidence interval based on the median +/− 1.58 (IQR/sqrt of n) [n = number of measurements]. Additionally, the mean value is indicated by a black square [formula image] and the cross symbol [+] displays the standard deviation. Bio-Oss (n = 34), NanoBone (n = 42), easy-graft CLASSIC (n = 41), easy-graft CRYSTAL (n = 38), Control Group (n = 36).
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