Abstract
The purpose of this study was to retrospectively investigate the outcomes of Brånemark System Mk III TiUnite/Groovy implants placed in patients at Kobe University Hospital. Various risk factors for implant failure, including mechanical coupling, were investigated by univariate and multivariate analysis. The predictive variables investigated included age, sex, smoking habit, general health, history of radiation therapy, application of a dentomaxillary prosthesis, type of prosthesis, use of alveolar bone augmentation, site of implant insertion, mechanical coupling between implants, and the length and diameter of the implants. Of the 907 implants investigated, only 23 were unsuccessful; the overall survival rate was 96.7%. Increased age, radiation therapy, application of a removable prosthesis or dentomaxillary prosthesis, lack of mechanical coupling between implants, and shorter implants (≤8.5 mm) were significant risk factors for implant failure according to univariate analysis ( P < 0.05). Multivariate analysis identified a significant association ( P < 0.05) between dental implant failure and a lack of mechanical coupling between implants (odds ratio 6.88) and shorter implants (≤8.5 mm) (odds ratio 3.43). The findings of this study demonstrated multivariate relationships between various risk factors and dental implant failure.
Dental implants are frequently used to support prosthetic reconstructions of an incomplete dentition, and the survival rate for dental implants is high. Dental implants have some advantages over conventional prosthetic treatment, because they protect the structure of the remaining teeth and reduce the probability that dentures will be required in the future.
Dental implant failure is characterized by mobility of the implant, continuing radiolucency around the implant, peri-implantitis with suppuration, or subjective complaints from the patient. Investigators have described several risk factors affecting implant survival rates, including the location of insertion (incisor or molar region, and maxillary or mandibular bone), the length, diameter, and design of the implant, the use of augmentation procedures, and patient-related risk factors such as age, smoking, history of periodontal disease, diabetes mellitus, and osteoporosis. However, the relationships between some risk factors and dental implant failure remain controversial. Few studies to date have evaluated the relationship between the mechanical coupling of the prosthesis and implant failure.
Brånemark System Mk III TiUnite/Groovy implants (Nobel Biocare, Gothenburg, Sweden) have been commercially available in Japan since December 2000. These implants have been used at Kobe University Hospital since July 2003. In this study, the outcomes of Brånemark System Mk III TiUnite/Groovy implants placed in patients at this hospital were investigated retrospectively, and the relationships between various risk factors, including mechanical coupling, and dental implant failure were examined.
Materials and methods
A total of 907 Brånemark System Mk III TiUnite/Groovy implants were placed in 115 male patients and 127 female patients by dentists of the Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, between July 2003 and December 2013. These implants were investigated in this study.
The mean age of the patients was 52.1 ± 15.6 years (range 16–90 years). Before surgery, each patient was informed about possible complications, including potential risks during the procedure, and each patient provided full informed consent. The implantation was performed as a two-stage surgical procedure.
The most common age group of the patient sample was 50–59 years ( Fig. 1 ); 326 implants (35.9%) were inserted in this age group. Forty patients had completely edentulous jaws (19 maxillae and 21 mandibles) and 202 had partially edentulous jaws (104 maxillae and 98 mandibles). The mean follow-up time for the implants that survived was 71.3 months (range 12–137 months). Patients who did not attend an examination for any reason during the first 12 months of follow-up were excluded.
In this study, implant success was defined according to Buser et al., using the following criteria: (1) absence of persistent subjective complaints such as pain, foreign body sensation, and/or dysesthesia; (2) absence of peri-implant infection with suppuration or mobility; and (3) absence of a continuous radiolucency around the implant. In the case that an implant was associated with a history of acute infection with suppuration and progressive bone loss, this was classified as implant survival and not as implant success.
The alveolar bone at the sites of implant insertion was evaluated by panoramic radiography and computed tomography (CT). The medical CT images were taken using an Aquilion 64 scanner (Toshiba Medical Systems, Tokyo, Japan). The axial plane was set parallel to the occlusal plane, and continuous 0.625-mm slices were taken. Coronal and sagittal images were reconstructed from the raw data.
The predictive variables investigated were patient age (≥60 or <60 years old), sex, smoking habit, general health (history of steroid treatment, diabetes mellitus, osteoporosis), history of radiation therapy, application of a dentomaxillary prosthesis, type of prosthesis (fixed/removable), use of alveolar bone augmentation, the site of implant insertion (anterior/posterior), mechanical coupling between implants, the type of edentulism (complete or partial), and the length (≤8.5 or ≥10 mm) and diameter (≤3.3 or ≥3.75 mm) of the implants. All factors are listed in Table 1 . The end point was defined as the failure of an implant, loss to follow-up, or September 2015.
| Variable | Failure | Survival | P -value |
|---|---|---|---|
| Sample size | 23 (2.5) | 884 (97.5) | |
| Sex | 0.295 | ||
| Male | 15 (65.2) | 471 (53.3) | |
| Female | 8 (34.8) | 413 (46.7) | |
| Age | 0.005 | ||
| <60 years | 9 (39.1) | 613 (69.3) | |
| ≥60 years | 14 (60.9) | 271 (30.7) | |
| Smoker | 0.160 | ||
| Yes | 10 (43.5) | 253 (28.6) | |
| No | 13 (56.5) | 631 (71.4) | |
| Diabetes mellitus | 0.156 | ||
| Yes | 2 (8.7) | 26 (2.9) | |
| No | 21 (91.3) | 858 (97.1) | |
| Steroid treatment | 0.207 | ||
| Yes | 1 (4.3) | 8 (0.9) | |
| No | 22 (95.7) | 876 (99.1) | |
| Osteoporosis | 0.518 | ||
| Yes | 1 (4.3) | 27 (3.1) | |
| No | 22 (95.7) | 857 (96.9) | |
| Radiation therapy | 0.009 | ||
| Yes | 3 (13.0) | 15 (1.7) | |
| No | 20 (87.0) | 869 (98.3) | |
| Type of edentulism | 0.125 | ||
| Complete | 8 (34.8) | 187 (21.2) | |
| Partial | 15 (65.2) | 697 (78.8) | |
| Implant site | 1.000 | ||
| Maxilla | 12 (52.2) | 463 (52.4) | |
| Mandible | 11 (47.8) | 421 (47.6) | |
| Implant region | 1.000 | ||
| Incisor | 8 (34.8) | 307 (34.7) | |
| Molar | 15 (65.2) | 577 (65.3) | |
| Bone augmentation | 1.000 | ||
| Yes | 8 (34.8) | 410 (46.4) | |
| No | 15 (65.2) | 474 (53.6) | |
| Type of prosthesis | 0.003 | ||
| Fixed | 10 (43.5) | 743 (84.0) | |
| Removable | 8 (34.8) | 126 (14.3) | |
| Unknown | 5 (21.7) | 15 (1.7) | |
| Dentomaxillary prosthesis | 0.002 | ||
| Yes | 6 (26.1) | 62 (7.0) | |
| No | 12 (52.2) | 807 (91.3) | |
| Unknown | 5 (21.7) | 15 (1.7) | |
| Mechanical coupling between implants | 0.001 | ||
| Separated | 7 (30.4) | 126 (14.3) | |
| Coupled | 6 (26.1) | 741 (83.8) | |
| Unknown | 10 (43.5) | 17 (1.9) | |
| Implant length | 0.022 | ||
| ≤8.5 mm | 8 (34.8) | 139 (15.7) | |
| ≥10 mm | 15 (65.2) | 745 (84.3) | |
| Implant diameter | 0.762 | ||
| ≤3.3 mm | 4 (17.4) | 128 (14.5) | |
| ≥3.75 mm | 19 (82.6) | 756 (85.5) |
Statistical analysis
The data collection and statistical analyses were performed using SPSS version 15 software (SPSS Inc., Chicago, IL, USA). The association of each variable with the failure of implants was tested by non-parametric Mann–Whitney U -test for ordinal variables and Fisher’s exact test or the χ 2 test for categorical variables. A value of P < 0.05 was considered statistically significant.
The cumulative implant survival rate was calculated using the Kaplan–Meier product-limit method. The level of significance among the curves was determined using the log-rank test. A value of P < 0.05 was considered statistically significant.
All of the variables associated with implant failure were introduced into a multiple logistic regression model. Forward stepwise algorithms were used, with the rejection of those variables that did not fit the model significantly. Factors found not to be indicated as significant in the univariate analysis were excluded from this model. The multivariate odds ratio (OR) and 95% confidence interval (CI) were also calculated for the significant factors. A value of P < 0.05 was considered statistically significant. The discriminant hit ratio (98.5%) was considered to be excellent in this study.
Results
The most common reason for missing teeth was periodontitis or dental caries (357 implants, 39.4%), followed by trauma (147 implants, 16.2%) and tumours (96 implants, 10.6%). The distribution of the implant sites is shown in Fig. 2 . The predominant location for fixture placement was the first molar region (191 implants, 21.1%).
Alveolar bone augmentation was performed for 418 implants (46.1%). The most common method of implantation was sinus lifting (173 implants, 19.1%) ( Table 2 ).
| Method | Number of implants (%) |
|---|---|
| None | 489 (53.9) |
| Maxillary sinus lifting | 173 (19.1) |
| Veneer bone graft | 92 (10.1) |
| Guided bone regeneration | 73 (8.0) |
| Vertical distraction osteogenesis | 30 (3.3) |
| Reconstruction with fibula flap | 23 (2.5) |
| Split crest | 20 (2.2) |
| Onlay bone grafting | 14 (1.5) |
| Other | 2 (0.2) |
The fixture sizes are shown in Fig. 3 . The most common fixture size selected was 3.75 mm diameter and 10 mm length (226 implants, 24.9%), followed by 3.75 mm diameter and 11.5 mm length (139 implants, 15.3%).
The risk factors associated with implant failure are shown in Table 1 . Demographic factors such as sex, smoking, history of steroid treatment, diabetes mellitus, and osteoporosis were not implicated as significant risk factors ( Table 1 ). Increased age and radiation therapy were significant risk factors for implant failure according to the univariate analysis ( P < 0.05) ( Table 1 ). However, bone augmentation, the site of the implant (incisor or molar region, and maxilla or mandible), the type of edentulism (complete or partial), and the diameter of the implant were found not to be significant risk factors ( Table 1 ). The application of a removable prosthesis or dentomaxillary prosthesis, a lack of mechanical coupling between implants, and shorter implants (≤8.5 mm) were significant risk factors for implant failure according to the univariate analysis ( P < 0.05) ( Table 1 ).
Applying the logistic regression model with forward stepwise algorithms, it was found that a lack of mechanical coupling between implants (OR 6.88) and shorter implants (≤8.5 mm) (OR 3.43) were significant variables ( Table 3 ).
| Variable | P -value | OR | 95% CI | |
|---|---|---|---|---|
| Lower | Upper | |||
| Lack of mechanical coupling | 0.001 | 6.88 | 2.26 | 20.94 |
| Shorter implant length (≤8.5 mm) | 0.036 | 3.43 | 1.09 | 10.85 |
There were only 23 implant failures among the 907 implants, and the 10-year overall survival rate was 96.7% in this study ( Fig. 4 ). The 10-year overall success rate was 92.0%. Details of the implant failure cases are presented in Table 4 . In the failed cases, the demographic risk factors identified were smoking, radiation therapy, diabetes mellitus, and steroid treatment. Five of the 23 failed implants failed before loading, and 18 implants failed after loading. The median duration to implant failure was 8 months, with a range of 1–94 months. Two implants in the mandible that failed before loading seemed to be affected by heat-induced bone tissue injury (HBTI). Three implants that failed before loading in the maxilla seemed to be affected by poor primary stability. Three implants were surgically removed because of the treatment of a recurrent tumour. Five out of six failed implants (83.3%) associated with a dentomaxillary prosthesis seemed to be affected by premature loading or overloading.
| Case No. | Sex | Age, years | Risk factors | Implant site a | Bone augmentation | Implant diameter/length | Type of prosthesis | Mechanical coupling between implants | Local incident | Survival, months |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | F | 65 | Smoking | U/M2 | None | 5/8.5 | Fixed | Coupling | Peri-implantitis | 63 |
| 2 | F | 36 | None | L/P1 | None | 4/18 | Fixed | Coupling | Peri-implantitis | 10 |
| 3 | F | 72 | None | U/P1 | None | 3.3/10 | Unknown | Unknown | Poor primary stability | 1 |
| 4 | F | 83 | None | U/C | None | 3.75/8.5 | DMP | Unknown | Recurrence of tumour | 3 |
| 5 | M | 53 | Smoking/radiation | L/M1 | None | 5/7 | Fixed | Coupling | Peri-implantitis | 16 |
| 6 | M | 56 | None | U/M1 | None | 4/10 | Fixed | Coupling | Peri-implantitis | 49 |
| 7 | M | 79 | None | U/I1 | None | 3.75/7 | DMP | Unknown | Premature loading | 4 |
| 8 | M | 79 | None | U/C | None | 3.75/13 | DMP | Unknown | Premature loading | 4 |
| 9 | M | 82 | None | L/I1 | None | 3.75/11.5 | DMP | Coupling | Premature loading | 1 |
| 10 | M | 71 | None | L/M1 | None | 5/10 | Unknown | Unknown | HBTI | 1 |
| 11 | M | 43 | Smoking | L/M2 | None | 4/11.5 | Fixed | Separate | Peri-implantitis | 16 |
| 12 | M | 60 | Smoking | L/I1 | None | 3.75/11.5 | Removable | Separate | Overloading | 30 |
| 13 | M | 64 | Smoking | L/C | None | 3.75/13 | Removable | Separate | Overloading | 44 |
| 14 | M | 70 | Smoking/DM | U/M1 | None | 5/8.5 | Fixed | Separate | Peri-implantitis | 22 |
| 15 | F | 34 | Smoking/steroids | U/P2 | Sinus lifting | 3.75/11.5 | Fixed | Separate | Peri-implantitis | 38 |
| 16 | F | 54 | None | U/C | GBR | 3.75/11.5 | Unknown | Unknown | Poor primary stability | 1 |
| 17 | F | 67 | None | U/M1 | Sinus lifting | 3.75/8.5 | Fixed | Separate | Recurrence of tumour | 94 |
| 18 | F | 67 | None | U/M2 | Sinus lifting | 3.75/8.5 | Fixed | Separate | Recurrence of tumour | 94 |
| 19 | M | 74 | Smoking/radiation | L/I1 | Reconstruction | 3.3/10 | DMP | Unknown | Premature loading | 2 |
| 20 | M | 74 | Smoking/radiation | L/P2 | Reconstruction | 3.3/10 | DMP | Unknown | Premature loading | 2 |
| 21 | M | 65 | None | L/P2 | GBR | 3.3/10 | Fixed | Coupling | Overloading | 8 |
| 22 | M | 54 | Smoking/DM | L/M1 | GBR | 3.75/10 | Unknown | Unknown | HBTI | 2 |
| 23 | M | 59 | None | U/M1 | None | 3.75/8.5 | Unknown | Unknown | Poor primary stability | 3 |
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