J Clin Periodontol 2013; 40: 553562 doi: 10.1111/jcpe.

12093

One-piece zirconia oral implants: one-year results from a prospective case series. 2. Three-unit xed dental prosthesis (FDP) reconstruction
Kohal R-J, Patzelt SBM, Butz F, Sahlin H. One-piece zirconia oral implants: one-year results from a prospective case series. 2. Three-unit xed dental prosthesis (FDP) reconstruction. J Clin Periodontol 2013; 40: 553562. doi: 10.1111/ jcpe.12093.

Ralf-Joachim Kohal1, Sebastian B. M. Patzelt2,3, Frank Butz3 and Herman Sahlin4

Department of Prosthodontics, School of Dentistry, Albert-Ludwigs University, Freiburg, Germany; 2Department of Periodontics, School of Dentistry, University of Maryland, Baltimore, USA; 3Department of Prosthodontics, School of Dentistry, Albert-Ludwigs University, Freiburg, Germany; 4Nobel Biocare, Gothenburg, Sweden
1

Abstract Aim: To evaluate the clinical and radiological outcome of one-piece zirconia oral
implants for three-unit xed dental prosthesis (FDP) replacement after 1 year. Materials: Twenty eight patients were recruited for the investigation and signed an informed consent. All patients were treated with a one-stage implant surgery and a three-unit immediate temporary restoration on two one-piece zirconia implants. The implants were fabricated of yttria-stabilized tetragonal zirconia (y-TZP). The endosseous part of the implants was tapered with a porous surface. A total of 56 implants were inserted in the 28 patients. A total of 12 implants were placed in the upper jaws (six in the anterior area and six in the posterior area) and 44 in mandibles (all in the posterior area). At implant insertion and after 1 year, standardized radiographs were taken to evaluate the peri-implant bone loss. To evaluate any inuences from different baseline parameters on the marginal bone loss a univariate analysis was performed. Clinical soft tissue parameters probing depth (PD), clinical attachment level (CAL), modied bleeding index (mBI) and modied plaque index (mPI) were recorded. Implant cumulative survival rates were calculated using actuarial life table analysis. Changes in the clinical variables were assessed using the Wilcoxon Signed Ranks test (PD, CAL) and the Sign test (mBl, mPl). All signicance tests were conducted at a 5% level of signicance. Results: After 1 year, one implant was lost resulting in a survival rate of 98.2%. The patient was excluded from further analysis. The marginal bone loss after 1 year amounted to 1.95 mm. In 40% of the patients a bone loss of at least 2 mm and in 28% of the patients a loss of more than 3 mm were observed. The PD decreased for implant and tooth sites over time, the values being signicantly higher for implants than for teeth. Over 1 year, the CAL increased slightly around the implants and decreased around the teeth. At the 1-year follow-up, the CAL at the implant sites was statistically signicantly higher than at the reference teeth. The mBI was signicantly lower at implants than at teeth. The same result was found for the plaque index. Conclusions: A high frequency of increased radiographic bone loss (>2 mm) after 1 year around the presented one-piece zirconia implant system was found. The bone loss seems to be higher compared to the very limited availability of zirconia implant data. Therefore, within the limits of the present investigation, it may be concluded that the presented zirconia implant system possibly performs inferior to conventional titanium implants and to other zirconia implants regarding peri-implant bone loss.

Key words: clinical investigation; xed dental prosthesis; oral implant; prospective; three-unit bridge; zirconia Accepted for publication 3 February 2013

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to name a few). The minority of these companies has clinical research data for their implant systems; and some of these data are of questionable scientic quality (Andreiotelli et al. 2009, Depprich et al. 2012). For example, when a non-systematic electronic search (key words: zirc* AND impl*) and a hand search were performed, no clinical investigations could be found for the Incermed system. Five clinical investigations were found for the z-systems system (Blaschke & Volz 2006, Mellinghoff 2006, Lambrich & Iglhaut 2008, Cannizzaro et al. 2010, Gahlert et al. 2012b) and three clinical investigations for the White Sky implant system of Bredent medical (Borgonovo et al. 2010, 2011, Payer et al. 2012). Two scientic reports could be located for the CeraRoot System (Oliva et al. 2007, 2010). For the remaining zirconia implant systems no scientic literature regarding implant survival/ implant success could be found in peer-reviewed journals (case reports excluded). Apart of the investigations of Cannizzaro et al. (2010) and Payer et al. (2012), all other reports had a low level of evidence due to a questionable study design (Depprich et al. 2012). In this context, another aspect of interest might be that all clinical investigations or reports, in contrast to this study, were published at some period after the launch of the respective implant system. Cohort investigations with a prospective study design are rare for zirconia oral implants (Payer et al. 2012). Therefore, it was the aim of the present cohort investigation to clinically evaluate a zirconia implant system prior to market launch. It was the objective of this investigation to obtain 1 year data on the survival/ success of a newly developed zirconia implant system when applied as abutments for three-unit xed dental prostheses. The soft and hard tissue response around these implants was the secondary objective.
Materials and Methods

Conict of interest and source of funding statement Dr. Kohal was a lecturer for Nobel Biocare from 2005 to 2008 and Dr. Butz was a lecturer for Nobel Biocare in 2007. Dr. Sahlin is an employee of Nobel Biocare, Gothenburg, Sweden. This investigation was supported by a grant from Nobel Biocare, Gothenburg, Sweden grant # T-114. The zirconia implants and the zirconia frameworks were provided by Nobel Biocare.

Zirconia oral implants are a topic of interest to dental researchers and dentists. Although, those implants are on the market for a certain period of time, the scientic backup on the clinical use of such implants is lagging behind or non-existent. In different review articles, the biological behaviour (i.e. osseointegration) of zirconia implants was elucidated (Wenz et al. 2008, Andreiotelli et al. 2009, Silva et al. 2010). A compilation of animal experiments in the review of Silva and co-workers (Silva et al. 2010) showed that the utilized zirconia implants developed a similar bone-to-implant contact as did the titanium implant controls. Numerous additional animal experiments, published after the review of Silva et al. (2010), supported the ndings that zirconia implants obtained an amount of osseointegration not different from titanium implants (Gahlert et al. 2010, 2012a, Koch et al. 2010, Schliephake et al. 2010, Stadlinger et al. 2010, Aboushelib ller et al. 2012). Some et al. 2011, Mo of those investigations could even show slightly superior results of the zirconia implants (Koch et al. 2010, Stadlinger et al. 2010, Aboushelib et al. 2011). The positive biomechanical as well as pre-clinical biological results might encourage the use of zirconia implants and therefore several implant companies brought zirconia oral implants to the market (Silva et al. 2010) (e.g. Incermed, Lausanne, Switzerland; Z-systems, Oensingen, Switzerland; Bredent medical, Senden, Germany; Ceraroot, Granollers, Spain; Creamed, Marburg, Germany; Metoxit, Thayngen, Switzerland; Dentalpoint, Zurich, Switzerland; BPISystems, Sindelngen, Germany

implant surgery and a three-unit immediate temporary restoration supported by two implants. Main inclusion criteria were that the subjects were between 18 and 70 years old, had to be in need of an implant-supported three-unit xed dental prosthesis (FDP) supported by two implants, and had to be systemically healthy. Furthermore, a sufcient bone volume in the prospective implant regions had to be present for receiving implants with a diameter of at least 4.3 mm and minimal length of 10 mm. The subjects had to have a stable occlusal relationship with no severe parafunctional habits and the implant sites had to be free of infection and/ or tooth remnants. Exclusion criteria were among others: alcohol or drug abuse; general health conditions that did not permit a surgical procedure, for example, infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoietic system, haematological disorders, wound healing disturbances, disorders of the endocrine system and pregnancy. Local contraindications were, for example, tumours, ulcers. In addition, reasons to believe that the treatment might have a negative effect on the subjects psychological situation were exclusion criteria. The need for extended bone augmentation before implant installation to obtain a prosthetically correct implant position was an exclusion criterion as well. However, a minor augmentation procedure to cover exposed threads due to decient sites was not an exclusion criterion. The investigation was approved by the ethics committee of the University Medical Center Freiburg, Freiburg, Germany (investigation number: 337/04).
Pre-treatment examination

This study was a prospective investigation. 28 patients were recruited and were informed on the content and duration of the study. Prior to the start of the study, they had to sign an informed consent. All 28 patients were treated with a one-stage

Before treatment, the patients medical history was recorded and a clinical and radiographic examination was performed. The areas of implantation were evaluated with a cone beam computed tomogram (Newtom 3G, Newtom, Marburg, Germany). According to the available bone, the lengths and the diameters of the implants were selected.
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Investigational zirconia implants

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The yttria-stabilized tetragonal zirconia polycrystal implants (y-TZP; zirconia implants) (Nobel Biocare) featured a design similar to the titanium one-piece NobelDirectTM implant (Nobel Biocare, Gothenburg, Sweden). The endosseous part of the implants was tapered and roughened (ZiUniteTM surface technology, Nobel Biocare), (Sennerby et al. 2005). A porous implant surface was achieved by a sintering-on technique of zirconia slurry onto the implant cylinder that contained zirconia powder and a burnable pore former. While sintering the implant coating, the pore former burnt out, leaving a porous implant surface. The topographical analysis of the implant surface revealed for Sa (average surface roughness) 1.24 lm, for Sds (value for the number of peaks per area unit) 0.09/lm2, and for Sdr (developed surface area) 83% (Sennerby et al. 2005). The transmucosal part of the one-piece zirconia implants was also roughened in its apical part, whereas the coronal part, for the placement of the bridge retainer (abutment part), had a machined surface. The implant lengths available were 10, 13 and 16 mm and the diameters were 4.3 mm Regular Platform (RP) and 5.0 mm wide [Wide Platform (WP)]. All implants were CE-marked.

Implant placement

The implants were placed under peri-operative antibiotic coverage (Clindamycin 300 mg N1, 3 9 per day, starting 1 day before surgery and lasting 2 days after the day of surgery) and pain control was executed using ibuprofen. The patients used the analgesic after the surgery according to their individual needs. There was no restriction in the study design regarding the type of implant receiving sites. The implants were either placed immediately into extraction sockets or in so called healed sites (healing time at least 46 months). The ap design for the placement of the implants into the healed sites was apless, a soft tissue punch technique or a full-thickness mucoperiosteal ap. All implants were placed according to the manufacturers recommendations.
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After implant placement, the implant abutment part was slightly prepared for the incorporation of the three-unit temporary bridge. All implants were immediately restored with provisionals that were re-lined using a self-curing acrylic material. All centric and eccentric contact points, as well as the approximal contacts, were removed to avoid any forces from occlusion onto the implants. The status quo of the marginal bone was recorded by taking standardized radiographs with a customized intra-oral x-ray lm holder bite block (Rinn XCP, Dentsply Rinn, Elgin, USA). The lm holder was individualized with a self curing acrylic material before implant placement. In a malleable condition, the acrylic was attached to the holder. Then, the holder including the x-ray lm was brought into the intended position in the patients oral cavity. Care was taken to parallel the alignment of the x-ray lm in the lm holder to the anticipated long axis of the implants. After curing of the acrylic material under continuous cooling with water spray, excess material was removed and the lm holder position again inspected intraorally for t and alignment. If there was a problem in alignment or reproducibility in the holder position, the entire procedure was repeated until a satisfying result was obtained. After cementation of the temporary bridges, temporary cement remnants (Freegenol, GC Germany, Bad Homburg, Germany) were meticulously removed. Finally, the patients were provided with maintenance instructions which consisted of rinsing the oral cavity with a 0.2% chlorhexidine solution and were instructed not to clean the surgical areas with their tooth brush for at least 1 week. After a week, the patients were scheduled for wound inspection and for suture removal. Further controls and professional cleanings of the surgical areas were performed after 2, 4, 6 and 8 weeks and then on a monthly basis until the delivery of the nal prosthesis.
Delivery of the prosthesis

jaw. All-ceramic three-unit bridges were processed with a zirconia framework (Procera, NobelBiocare, Sweden) and a glass-ceramic veneering material (NobelRondo, NobelBiocare, Sweden). The three-unit xed dental prostheses were conventionally cemented using glassionomer cement (KetacTM Cem, 3M Espe, Neuss, Germany). The cement remnants were thoroughly removed and the patients inspected again after one to three days.
Summary information on patients and implants

Overall, 28 patients (11 females and 17 males; all non-smokers) were included in this investigation and a total of 56 implants were placed supporting 28 three-unit xed dental prostheses. 24 patients were older than 41 years. 12 implants were placed in the upper jaws (6 in the anterior area and 6 in the posterior area) and 44 in the lower jaws (all in the posterior area). 30 implants had a diameter of 5 mm and 26 of 4.3 mm. Of the 56 implants, ve implants (9%) were placed in extraction sockets (two implants in a apped procedure) and 51 implants in healed sites (ve implants using a punch technique, two implants with a apless procedure).
Follow-ups

Radiographic assessment With the application of the individualized x-ray holder (long-cone parallel technique), standardized radiographs were taken after implant placement, after FDP delivery, and at the 1-year follow-up. The radiographs at implant placement were used as baseline values. The lower edge of the implant abutment part where the transition zone between the straight abutment part and the implant threads was located was utilized as the reference point for the measurements of bone remodelling/ loss (Fig. 1). Bone remodelling/loss from implant placement to the 1-year follow-up was evaluated. A calibration of all radiographs was performed using the known width of the base of the abutment part of the ceramic implants. A radiologist at the Gothenburg University, Sweden, evaluated the radiographs indepen-

For prosthesis fabrication, impressions of the implants were performed after approximately 6 weeks in the lower jaw and 14 weeks in the upper

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index (mPI) also according to Mombelli et al. (1987). The soft tissue measurements were performed using a periodontal probe. The values for the PD and for the CAL were rounded to the nearest millimetre. Statistical analysis Implant cumulative survival rates were calculated using actuarial life table analysis (Altman 1999). Descriptive statistics, including mean values and standard deviations, were used for the presentation of the bone remodelling results. A univariate analysis of marginal bone loss from implant insertion to the 1-year follow-up was performed evaluating the effect of different baseline variables. To evaluate the effects of ordered categorical and continuous baseline variables, Spearman correlation coefcient was used. The effects of dichotomous baseline variables on bone remodelling were evaluated using the Mann Whitney U-test. Mean and standard deviation values were calculated for the clinical variables (PD, CAL, mBI, mPI) and the values for the implants were compared to values obtained from the neighbour teeth using the MannWhitney U-test. Changes in the clinical variables over time were assessed using the Wilcoxon Signed Ranks test (PD, CAL) and the Sign test (mBl, mPl). All signicance tests were two-tailed and conducted at a 5% level of signicance. All analyses were performed using SPSS (version 20.0; IBM Corporation; Armonk, NY, USA).
Results
Status of follow-up and implant failure

dently. She was not involved in the clinical part of the investigation. Bone remodelling was calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodelling was then calculated for each implant site. The mean value for all implants in each patient was further calculated from the mean of each implant. Bone loss criteria and implant success rating In the present investigation, the rec ommendation of Ostman et al. (2007) that more than 1 mm of bone loss during the rst year is acceptable for one-piece implants, was adopted. Therefore, their success grade I was applied to implants showing 2 mm bone loss after 1 year and no clinical and radiographic signs of pathology. The success grade II was applied to implants showing no pathology but a bone loss/resorption of 3 mm at the 1-year follow-up. Clinical evaluation The follow-ups were scheduled for 6 months and 1 year after implant placement. The clinical evaluation around the implants as well as around the adjacent natural teeth comprised the recording of probing depth (PD), clinical attachment level (CAL), the modied bleeding index (mBI) according to Mombelli et al. (1987), and the modied plaque

Of the 28 patients, 27 patients received the nal FDP. One implant was lost in one patient prior to reconstruction. The implant was mobile 2 weeks after insertion and had to be removed. No signs of acute infection were detectable. At the 6-month follow-up, 25 patients were seen (two patients did not attend the follow-up due to time conicts). At the 1-year follow-up, all 27 patients were available for clinical and radiographic evaluation.
Life-table analysis (on implant level)

One implant, placed into an extraction socket, failed after 21 days and had to be removed. No further implant losses occurred. The cumulative survival rate of the implants after 1 year was 98.2%.
Marginal bone remodelling (Marginal bone loss/gain on patient level) (Table 1 & 2)

Fig. 1. Indication of reference points for the bone level measurements. The coronal reference points differed in height at the mesial and distal implant aspect due to the starting thread.

The marginal bone loss evaluation from implant insertion to prosthesis insertion could be evaluated for 24 patients (for three patients one of the x-rays was rated as non-readable) and for 25 patients (for two patients the x-rays from the insertion time point were rated as non-readable) from implant insertion to the 1-year follow-up. A bone loss of 1.65 mm could be observed from implant insertion to the bridge delivery. In two patients (2%), the implant sites gained some bone. However, in nine patients (38%) implant sites lost more than 2 mm of peri-implant bone. A bone loss of more than 3 mm occurred around implants in three patients (13%). Figures 2 and 3 present radiographs of two patients that experienced increased bone loss. From implant insertion to the 1-year follow-up, an average bone loss of 1.95 mm was found. Again, implant sites in two patients (2%) gained some bone. In 10 patients (40%), the implant sites lost more than 2 mm of bone. The implant sites in seven patients (28%) lost more than 3 mm of bone and implant sites in three patients (12%) even lost more than 4 mm of peri-implant bone.
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When the success criteria dened according to Ostman and co-workers (Ostman et al. 2007, 2008) were applied to the present ndings of bone loss, 62% of the patients were classied as success grade I and 87% as success grade II at the time-point of FDP installation. At the 1-year follow-up, 60% of the patients were success grade I and 72% success grade II. The univariate analysis of the baseline variables possibly inuencing the bone loss around the implants is shown in Table 3. A correlation could be found for bone loss and the ap design (p = 0.01). Implants either placed without a ap or implants placed with the punch technique showed signicantly more bone loss than implants that were placed in a apped approach.
Peri-implant soft tissue evaluation (on patient level) (Table 4)

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Table 2. Bone loss at all individual implant sites Patient Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Mesial bone loss anterior implant Distal bone loss anterior implant Mesial bone loss posterior implant Distal bone loss posterior implant 0.3 1.9 X-ray not usable 3.6 1.3 5.4 1.2 0.3 0.5 0.5 2.3 4.0 1.3 X-ray not usable 1.6 2.0 X-ray not usable 1.2 2.8 0.5 1.0 7.0 5.0 6.3 X-ray not usable

At the time-point of the insertion of the three-unit xed dental prostheses, a mean PD of 2.85 mm around the zirconia implants and of 2.39 mm around the reference teeth was observed (p = 0.007). At the implant sites as well as at the tooth sites, the PD decreased from prostheses insertion to the 1-year followup. The PD for implants was 2.65 mm and for the teeth 1.97 mm at 1 year. The difference between implants and teeth was again statistically signicant (p < 0.001). The reduction in PD was signicant for the teeth (p = 0.002) but not for the implants (p = 0.284).

Radiograph from insertion time point not readable 2.3 1.5 1.6 0.1 0.2 1.3 1.0 0.0 7.5 2.5 4.0 4.8 4.7 2.4 1.0 5.1 2.0 6.5 1.3 1.0 1.0 1.8 0.3 0.5 1.1 0.9 0.9 ? 0.4 Radiograph from insertion time point not readable 1.5 2.1 2.7 2.0 4.8 5.1 3.6 2.5 1.5 1.8 1.0 1.4 1.5 2.3 2.0 0.4 0.9 0.0 0.3 2.6 1.0 4.0 4.0 1.5 1.0 1.2 3.4 Implant loss, dropout 0.9 0.2 0.2 1.0 1.5 0.5 4.0 3.5 5.5 X-ray not usable 5.5 4.0 0.5 2.0 5.5 2.3 4.0 0.7

The CAL had a mean of 3.14 mm at the implant sites and 3.04 mm at the reference teeth when the bridges were installed. The difference was statistically not signicantly different (p = 0.432). Until the

1-year follow-up, the CAL increased slightly around the implants to 3.24 mm (p = 0.584) and decreased around the teeth to 2.69 mm (p = 0.059). At the 1-year follow-up, the CAL at the implant sites was

Table 1. Marginal bone remodelling (on patient level) Implant Implant insertion insertion to Prosthesis to 1-year insertion follow-up Number 24 Mean value (mm) 1.65 SD (mm) 1.27 n (%) >0 mm 2 (8) 0 mm 0 (0) 0.1 to 1.0 mm 7 (29) 1.1 to 2.0 mm 6 (25) 2.1 to 3.0 mm 6 (25) 3.1 to 4.0 mm 3 (13) < 4.0 mm 0 (0) 2013 John Wiley & Sons A/S 25 1.95 1.71 N (%) 2 (8) 0 (0) 7 (28) 6 (24) 3 (12) 4 (16) 3 (12)

Fig. 2. The upper radiograph was taken at implant insertion, the lower radiograph at the 1-year follow-up. An increased bone loss around the distal implant is visible.

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cantly lower in comparison to the literature for immediately restored implants (Ostman et al. 2008, Van de Velde et al. 2010, Crespi et al. 2012, De Bruyn et al. 2012). The results of the present investigation corroborated the results obtained in the previous investigation of our group when using the one-piece zirconia implant for single tooth reconstruction (Kohal et al. 2012). Although increased bone loss was found radiographically, the clinical parameters in the present investigation did not indicate the presence of any peri-implant tissue problem. Altthough PDs and CALs were signicantly higher around the implants than around the teeth, this result was shown to be a normal nding. Animal investigations demonstrated that even in healthy conditions the tip of a periodontal probe was closer to the bone around implants than around teeth. It was stated that periimplant soft tissues did not give as much resistance to probing as the periodontal tissues (Ericsson & Lindhe 1993, Schou et al. 2002). Clinical investigations have also shown that probing values around implants are generally higher than around teeth. Cutrim et al. (2011) reported mean PD of 3.313.39 mm around implants and of 2.372.44 mm around reference teeth after 1 year. The difference between implants and teeth was similar to our investigation of statistical signicance (Cutrim et al. 2011). These results were supported by Wolleb et al. (2012). In their recent investigation they showed that after a follow-up period of 5 years, the mean pocket PD was 3.72 mm around implants and 2.36 mm around teeth. Since the peri-implant soft tissue conditions did not indicate towards any pathology (PD: 2.65 mm; mBI: 0.15; mPI: 0.09) of the peri-implant tissues, the reason(s) for the increased frequency of bone loss of ! 2 mm have to be attributed to factors other than an inammatory reaction to plaque accumulation and bacterial burden. The univariate analysis of the marginal bone loss evaluating the effect of different baseline variables revealed that the ap design had an inuence on periimplant bone loss. Such a correlation, however, could not be found in the investigation of one-piece zirco 2013 John Wiley & Sons A/S

Fig. 3. The upper radiograph was taken at implant insertion, the lower radiograph at the 1-year follow-up. An increased bone loss around the distal implant is visible.

statistically signicantly higher than at the reference teeth (p = 0.001). At bridge installation, the mBI (Mombelli et al. 1987) was slightly higher at the implants (0.46) compared to the reference teeth (0.35; p = 0.484). At the 1-year follow-up, the mBI decreased at both implants and teeth sites. The value for implants (0.15), however, was signicantly different from the teeth (0.30; p = 0.026). The decrease in both groups was not statistically signicant (implants: p = 0.078; teeth: p = 0.523). The plaque index (mPI), showed a similar development over time. At prosthesis insertion, the mPI was 0.51 for the implant sites and 0.51 for the reference teeth (p = 0.669). After 1 year, the values dropped signicantly in both groups (implants: 0.09, p = 0.001; teeth: 0.27, p = 0.023). At the 1-year follow-up, the implant sites showed statistically less plaque than the teeth (p = 0.014).
Discussion

This case series is the rst report on using one-piece zirconia oral implants for three-unit xed implant supported reconstructions. In a recent report (Kohal et al. 2012), the indication of implant placement was the single tooth restoration. In the current investigation, the indication

was extended towards the rehabilitation of patients with a three-unit FDP. The implants were immediately temporized after insertion and denitively restored after 8 to 16 weeks. During the interval of this 1 year investigation, one implant was lost, giving a survival rate of 98.2%. The implant survival rate in our investigation was comparable to the implant survival rates reported in investigations over different evaluation periods with immediately restored implants (Chaushu et al. 2001, Ganeles & Wismeijer 2004, Finne et al. 2007, Ostman et al. 2007, 2008, Nissan et al. 2008, Cooper et al. 2010, Romanos et al. 2010, Zembic et al. 2012), and better than other investigations on one-piece zirconia implants showing survival rates of 87.5% to 95% (Cannizzaro et al. 2010, Kohal et al. 2010, Payer et al. 2012). However, for this high survival rate the increased bone loss (1.95 mm) after 1 year has to be taken into consideration. The success rate of the implants in our study was considerably lower than the survival rate when bone loss was considered. The success rate dropped to 60% when applying the success grade I (bone loss 2 mm) according to Ostman et al. (2007) and to 72% when success grade II (bone loss 3 mm) was used. These success rates after 1 year were signi-

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Table 3. Univariate analysis of marginal bone loss from implant insertion to the 1-year follow-up (three-unit xed dental prosthesis) Difference Mean (SD) Jaw type Maxilla Mandible Ant-post Anterior Posterior Position Posterior mandible Other positions Smoking No Yes Bruxism before treatment No Yes Bone quality 1 23 Bone quantity A B C D Bone level at placement Platform RP WP Implant length 10 mm 13 mm 16 mm Flap design No ap Punch Flap Site Immediate Healed Bone grafting No Yes Insertion torque 45 >45 2.87 (2.5) 1.83 (2.0) 2.82 (4.1) 1.93 (2.0) 1.83 (2.0) 2.87 (2.5) 1.98 (2.1) 1.98 (2.1) 1.31 (1.5) 2.13 (2.2) 1.31 2.21 2.52 5.20 (1.7) (2.2) (2.6) (1.0) 1.3 to 1.1 95% CI 3.4 to 1.3 10.8 to 9.0 1.3 to 3.4 0.5 to 2.1 p-value 0.27 Correlation r p-value

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0.90

0.27 0.28 0.37

0.08

0.12 0.97 0.07

0.87

2.02 (2.0) 1.95 (2.2) 1.62 (2.3) 2.48 (2.0) 1.13 (1.4) 4.52 (1.5) 4.13 (3.5) 1.66 (1.8) 2.65 (1.2) 1.94 (2.1) 1.78 (2.2) 2.11 (2.0) 2.02 (2.2) 1.90 (1.8)

0.48

0.41

0.01

3.2 to 1.8 1.0 to 1.6 1.4 to 1.1

0.39

0.31

0.69

SD, standard deviation; CI, condence interval.

nia implants applied for single tooth reconstructions (Kohal et al. 2012). Similarly, no differences on bone loss were reported in other investigations when the apless/punch technique was compared to raising a ap for implant placement (Becker et al. 2006, Van de Velde et al. 2010, De Bruyn et al. 2011, Zembic et al. 2012). The heterogeneous surgical protocol of immediate and late placed implants as well as the apless and the punch technique with the rela 2013 John Wiley & Sons A/S

tively small number of subjects have to be regarded as one limitation of this study. Investigations on other zirconia one-piece implant systems did not report on cases with increased bone loss (Cannizzaro et al. 2010, Payer et al. 2012). Cannizzaro et al. (2010) presented a bone loss of 0.70.9 mm around the zirconia implants in their investigation. Payer et al. (2012) presented a mean bone loss of 1.01 mm after 1 year and 1.29 mm after 2 years and the authors did not indicate that

increased bone loss occurred with the use of their zirconia implant. Although the increased bone loss in our investigation seemed to be correlated with apless approach, this nding, however, is not supported by other investigations. Therefore, there must be other factors related to the bone loss which could not be found with the evaluated variables in our investigation. As discussed in the report on single tooth restorations (Kohal et al. 2012), other authors reported similar bone loss problems using the one-piece Nobel Direct implant design (Albrektsson et al. 2007, Ostman et al. 2007, Sennerby et al. 2008, Zembic et al. 2012) which is similar to the zirconia ceramic implant design. However, several investigations with comparable research designs with immediate loading of the Nobel Direct implants (Siepenkothen 2007, Finne et al. 2012) as well as two-piece titanium implants (Proussaefs & Lozada 2004, Ostman et al. 2008, Siddiqui et al. 2008, Van de Velde et al. 2010, Crespi et al. 2012, De Bruyn et al. 2012) presented a marginal bone loss much lower than in above mentioned investigations and lower than in the present investigation on one-piece zirconia implants. In the investigations reporting on increased bone loss with the onepiece titanium implants, it was discussed that one possible reason for the bone loss could have been immediate loading (Albrektsson et al. 2007). Since we did not use a control group without immediate loading, we cannot support/reject this hypothesis. A further cause for the increased bone loss might have been entrapment of cement in the periimplant sulcus. However, the crown margins were placed only slightly intra-crevicularly and utmost care was given (retraction cords were placed during cementation) to remove all cement remnants. However, the increased bone loss in our investigation seems not to be related to a single variable but is to be assumed to result from a combination effect of different variables. Although, our investigation has been a prospective case series, one major shortcoming is that it was not designed as a randomized controlled clinical trial. A control group featuring titanium implants that would

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independently reviewed and approved by the Ethics Committee of the University Medical Center Freiburg, Freiburg, Germany investigation number: 337/04.
References
2.65 (0.62) 27 p = 0.284 3.14 (0.75) 27 3.24 (0.70) 27 p = 0.584 0.46 (0.55) 27 0.15 (0.18) 27 p = 0.078 0.51 (0.49) 27 0.09 (0.16) 27 p = 0.001 1.97 (0.35) 27 p = 0.002 3.04 (1.07) 27 2.69 (0.74) 27 p = 0.059 0.35 (0.44) 27 0.30 (0.33) 27 p = 0.523 0.51 (0.52) 27 0.27 (0.36) 27 p = 0.023 p = 0.000
Aboushelib, M., Salem, N., Abotaleb, A. & Abd El Moniem, N. (2011) Inuence of surface nano-roughness on osseointegration of zirconia implants in rabbit femur heads using selective inltration etching technique. Journal of Oral Implantology. doi:10.1563/AAID-JOI-D11-00075. Albrektsson, T., Gottlow, J., Meirelles, L., Ostman, P. O., Rocci, A. & Sennerby, L. (2007) Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers. Clinical Implants Dentistry and Related Research 9, 6570. Altman, D. G. (1999) Practical Statistics for medical research, (p. 613). Boca Raton: Chapman & Hall/CRC Press. Andreiotelli, M., Wenz, H. J. & Kohal, R. J. (2009) Are ceramic implants a viable alternative to titanium implants? A systematic literature review. Clinical Oral Implants Research 20 (Suppl 4), 3247. , U. M., Sennerby, L., QaBecker, W., Wikesjo hash, M., Hujoel, P., Goldstein, M. & Turkyilmaz, I. (2006) Histologic evaluation of implants following apless and apped surgery: a study in canines. Journal of Periodontology 77, 17171722. Blaschke, C. & Volz, U. (2006) Soft and hard tissue response to zirconium dioxide implants - a clinical study in man. Neuroendocrinology Letters 27, 6972. Borgonovo, A., Censi, R., Dolci, M., Vavassori, V., Bianchi, A. & Maiorana, C. (2011) Use of endosseous one-piece yttrium-stabilized zirconia dental implants in premolar region: a two-year clinical preliminary re-port. Minerva Stomatologica 60, 229241. Borgonovo, A. E., Arnaboldi, O., Censi, R., Dolci, M. & Santoro, G. (2010) Edentulous jaws rehabilitation with yttrium-stabilized zirconium dioxide implants: two years follow-up experience. Minerva Stomatologica 59, 381392. Cannizzaro, G., Torchio, C., Felice, P., Leone, M. & Esposito, M. (2010) Immediate occlusal versus non-occlusal loading of single zirconia implants. A multicentre pragmatic randomised clinical trial. European Journal of Oral Implantology 3, 111120. Chaushu, G., Chaushu, S., Tzohar, A. & Dayan, D. (2001) Immediate loading of single-tooth implants: immediate versus non-immediate implantation. A clinical report. International Journal of Oral and Maxillofacial Implants 16, 267272. Cooper, L. F., Raes, F., Reside, G. J., Garriga, J. S., Tarrida, L. G., Wiltfang, J., Kern, M. & de Bruyn, H. (2010) Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. International Journal of Oral and Maxillofacial Implants 25, 1222 1232. Crespi, R., Cappare, P., Gherlone, E. & Romanos, G. (2012) Immediate provisionalization of dental implants placed in fresh extraction sockets using a apless technique. International

Table 4. Peri-implant soft tissue evaluation Implants Probing depth Prosthesis insertion Mean (SD) n 1-year follow-up Mean (SD) n Signicance testa Clinical attachment level Prosthesis insertion Mean (SD) n 1-year follow-up Mean (SD) n Signicance testa Bleeding Prosthesis insertion Mean (SD) n 1-year follow-up Mean (SD) n Signicance testb Plaque Prosthesis insertion Mean (SD) n 1-year follow-up Mean (SD) n Signicance testb
a b

Ref. teeth

MannWhitney

2.85 (0.73) 27

2.39 (0.62) 27

p = 0.007

p = 0.432 p = 0.001

p = 0.484 p = 0.026

p = 0.669 p = 0.014

Wilcoxon signed ranks test (two-tailed, a = 0.05). Sign test (two-tailed, a = 0.05).

have been treated similarly to the utilized one-piece ceramic implants (immediate provisionalization, cementation of restoration) might provide information on whether the observed problems were related to the implant design or to the performed procedures. Future investigations applying implants made of high performance ceramics should include a control group and aim to specically evaluate the different inuencing parameters discussed elsewhere in the article.
Conclusions

to be regarded as satisfactory and as comparable to other implant investigations. However, the implants showed a high frequency of increased bone loss ( ! 2 mm) during the rst year after implant placement. Therefore, the success rate was signicantly lower than the survival rate. We were not able to relate the increased bone loss to a single (evaluated) variable.
Ethical Approval

The aim of the present cohort investigation was to evaluate the 1-year survival/success rates of a zirconia implant system prior to a potential market launch, when used for the treatment with a three-unit implant supported FDP. The implant survival rate of 98.2% after 1 year has

This clinical investigation has been conducted in accordance with the ethical principles of the World Medical Association Declaration of Helsinki and according to the laws of Germany. The clinical investigation was undertaken after informing the patient of the content, risk and benets of the study and after written consent of each participant was obtained. The investigation has been

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Zirconia implants for xed prosthesis

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Address: Ralf Kohal Hugstetter Strae 55 79106, Freiburg Germany E-mail: ralf.kohal@uniklinik-freiburg.de

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Kohal et al.

Clinical Relevance

Scientic rationale for the study: Ceramic implants, generally fabricated of yttria-stabilized zirconia tetragonal polycrystal, are of certain interest in oral implantology since several companies have launched their systems on the market. Ceramic implants might improve esthetics, reduce plaque accumulation and they would be the only implant treatment for patients opposing metal devices in their bodies. However, the safety and efcacy should have been evaluated in clinical investigations before market introduction. Through conducting clinical inves-

tigations, the limits of such an implant system can be evaluated. This prospective case series studied a prototype zirconia implant system in partially edentulous patients in need of a three-unit FDP. Principal ndings: The survival rate of the zirconia implant system in the present investigation was acceptable after 1 year and comparable to survival rates of titanium oral implants. However, the mean bone loss of 1.95 mm after one year exceeds the bone loss of two-piece titanium implants. Furthermore, the frequency of bone loss ! 2 mm was higher compared to two-piece titanium implants. The success rate of

the zirconia implants after one year was 60% on patient level when bone loss 2 mm was regarded as the acceptance limit and 72% on patient level when bone loss 3 mm was regarded as the acceptance limit. Practical implications: Our investigation showed that the evaluated zirconia implant seems to perform inferior to titanium implants after one year when applied for xed partial denture reconstructions and cannot be recommended for clinical routine due to the increased frequency of bone loss of more than 2 mm.

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