Patient- and clinician-reported outcomes for the additively manufactured sub-periosteal jaw implant (AMSJI) in the maxilla: a prospective multicentre one-year follow-up study.

The clinical outcomes of maxillary rehabilitation with the additively manufactured sub-periosteal jaw implant (AMSJI; CADskills BV) were evaluated in edentulous patients with a Cawood-Howell atrophy classification ≥5 in all regions of the maxilla. Fifteen consecutive patients were included in the study and followed up for 1 year. They were interviewed using a survey protocol and were examined clinically and radiographically preoperatively (T0) and at 1 (T1), 6 (T2), and 12 (T3) months after permanent upper prosthesis placement. The patients reported an increased oral health-related quality of life. The overall mean Oral Health Impact Profile-14 score at T0 was 17.20 (standard deviation (SD) 6.42). When results at T0 were compared to those at T1 (mean 8.93, SD 5.30), a statistically significant difference was seen (P = 0.001). At T3, the mean value was 5.80 (SD 4.18). Compared to T0, there was also a statistically significant difference at T3 (P = 0.001). General satisfaction based on the numerical rating scale was a mean 49.93 at T1, which was less than patient expectation prior to treatment at T0 (52.13). A higher overall value was seen at T3 (53.20) when compared to T0. Within the constraints of the short follow-up, the AMSJI appears to be a promising tool for patients with extreme jaw atrophy. The high patient expectations were met without complications.

Depth and lateral deviations in guided implant surgery: an RCT comparing guided surgery with mental navigation or the use of a pilot-drill template.

AIM: To assess the accuracy of guided surgery compared with mental navigation or the use of a pilot-drill template in fully edentulous patients. MATERIAL AND METHODS: Sixty consecutive patients (72 jaws), requiring four to six implants (maxilla or mandible), were randomly assigned to one of the following treatment modalities: Materialise Universal(®) mucosa, Materialise Universal(®) bone, Facilitate(™) mucosa, Facilitate(™) bone, mental navigation, or a pilot-drill template. Accuracy was assessed by matching the planning CT with a postoperative CBCT. Deviations were registered in a vertical (depth) and horizontal (lateral) plane. The latter further subdivided into BL (bucco-lingual) and MD (mesio-distal) deviations. RESULTS: The overall mean vertical deviation for the guided surgery groups was 0.9 mm ± 0.8 (range: 0.0-3.7) and 0.9 mm ± 0.6 (range: 0.0-2.9) in a horizontal direction. For the non-guided groups, this was 1.7 mm ± 1.3 (range: 0.0-6.4) and 2.1 mm ± 1.4 (range 0.0-8.5), respectively (P < 0.05). The overall mean deviation for the guided surgery groups in MD direction was 0.6 mm ± 0.5 (range: 0.0-2.5) and 0.5 mm ± 0.5 (range: 0.0-2.9) in BL direction. For the non-guided groups, this was 1.8 mm ± 1.4 (range: 0.0-8.3) and 0.7 mm ± 0.6 (range 0.0-2.9), respectively. The deviation in MD direction was significantly higher in the non-guided groups (P = 0.0002). CONCLUSION: The most important inaccuracy with guided surgery is in vertical direction (depth). The inaccuracy in MD or BL direction is clearly less. For non-guided surgery, the inaccuracy is significantly higher.

Ultrastructural characterization of the implant interface response to loading.

Dynamic loading can affect the bone surrounding implants. For ultrastructural exploration of the peri-implant tissue response to dynamic loading, titanium implants were installed in rat tibiae, in which one implant was loaded while the contralateral served as the unloaded control. The loaded implants received stimulation either within 24 hrs after implantation (immediate loading) or after a 28-day healing period (delayed loading) for 4, 7, 14, 21, or 28 days. The samples were processed for histology and gene expression quantification. Compared with the unloaded control, bone-to-implant contact increased significantly by immediate loading for 28 days (p < .05), but not in case of delayed loading. No effect of loading was observed on the bone formation in the implant thread areas, on the blood vessel area, and on endosteal callus formation. Loading during healing (immediate) for 7 days induced, relative to the unloaded control, a 2.3-fold increase of Runx2 in peri-implant cortical bone (p < .01) without a change in the RANKL/Opg ratio. Loading after healing (delayed) for 7 days up-regulated Runx2 (4.3-fold, p < .01) as well as Opg (22.3-fold, p < .05) compared with the unloaded control, resulting in a significantly decreased RANKL/Opg ratio. These results indicate a stimulating effect of dynamic loading on implant osseointegration when applied during the healing phase. In addition, gene expression analyses revealed molecular adaptations favoring bone formation and, at the same time, affecting bone remodeling.

Extra short dental implants supporting an overdenture in the edentulous maxilla: a proof of concept.

OBJECTIVES: This study investigates the outcome of short implants additionally placed with longer implants to support a maxillary overdenture. MATERIALS AND METHODS: Twelve patients received six implants to support a maxillary overdenture. Only one patient still had two molars in the maxilla, while the others had no remaining teeth. The status of the opposing arch was diverse. The distal implant in each quadrant was 6 mm in height (S) and the middle implants ranged between 10 and 14 mm (L). All implants were placed following a one-stage procedure and early loaded (6 weeks). Clinical and radiological parameters were assessed 6, 12 and 24 months after loading. RESULTS: One short implant failed 2 weeks after surgery, probably due to early mobilization by the provisional prosthesis. The mean bone loss on the rough part of the implant was 0.7 mm (S) vs. 1.3 mm (L) during the first year and 0.3 mm (S) vs. 0.2 mm (L) during the second year after loading. The mean implant stability quotient values were 67 (S) vs. 70 (L) at placement and 75 (S) vs. 78 (L) after 1 year. At the 2-year follow- up, all prostheses were still stable and comfortable. CONCLUSION: An overdenture on six implants, of which two have a reduced length, might represent a successful treatment option. No significant difference could be found between both implant lengths at 2 years' follow-up. However, bone loss with short implants may increase the likelihood of failure.

Model-based guided implant insertion for solitary tooth replacement: a pilot study.

OBJECTIVE: The impact of the implant position on the restorative outcome could justify guided surgery even for the single implants particularly in the aesthetic zone and especially when a simplified concept is available. MATERIAL AND METHODS: Based on a plaster model, on which the soft tissues were mimicked (according to the thickness measured on a Cone-Beam CT), a tooth-supported, surgical template was prepared. The latter guided all drills so that even flapless implant insertion became possible. All implants were placed by students of the master-after-master training program in Periodontology. RESULTS: The prospective cohort included a total of 34 implants, all of AstraTech (Osteospeed(®)) type, which were successfully inserted in 29 patients, 16 flapless, 32 onestage. The marginal bone along the integrated implants remained stable over time, with 0.13 mm loss during the first year. The aesthetic parameters were reassuring. CONCLUSIONS: This simple model-based concept seems to be reliable for the guided placement of single implants and the pre-operative preparation of their restorations.

Long-term, retrospective evaluation (implant and patient-centred outcome) of the two-implants-supported overdenture in the mandible. Part 1: survival rate.

OBJECTIVE: This retrospective analysis evaluated the long-term outcome of two implants supporting an overdenture in the mandible, as well as the significance of some confounding factors (smoking, implant length, bone quality). MATERIAL AND METHODS: All mandibular overdenture cases (n=495) treated during the past 25 years in our centre (with > or = 5 years loading of the implants) were included in this study. General information (medical history, implant data, report on surgery) was retrieved from the patient's file. A large number of patients (n=248) were willing to visit the clinic for an additional follow-up visit. For the others, information on implant survival was collected by phone (n=121), or contact was impossible (57 had died, three were hospitalized and 66 could not be reached). In the latter group, information was used, up to their last visit to the clinic. An implant was considered as surviving if it was still in function in the mouth, without clear adverse effects (pain, swelling, mobility). A failure was defined as early if it occurred within the window, insertion-final prosthesis placement; afterwards, it was considered as late. RESULTS: Most of the inserted implants (Brånemark type) were of the turned (machined) type (95.5%), the remainder was anodized (TiUnite). The anchoring system was either a bar (86.3%), ball attachments (11.7%) or magnets (1.6%), and only some patients changed from one to the other (0.4%). Kaplan-Meier analyses showed a survival rate of 95.5% after 20 years of loading. Factors that influenced the outcome included smoking (90% rate for smokers) and the surgical protocol (reduced survival rate for one-stage-placed implants). Implant length and bone quality had no impact. CONCLUSIONS: These results fully support the two-implant overdenture concept in the mandible even in the long run.

Effect of constant strain rate, composed of varying amplitude and frequency, of early loading on peri-implant bone (re)modelling.

AIM: Examine the effect of varying components of strain rate -- amplitude versus frequency -- while maintaining a constant strain rate of early controlled mechanical loading on implant stability, peri-implant bone mass and bone-to-implant contact. MATERIAL AND METHODS: Three groups of guinea-pigs received TiO2 -blasted implants in both tibiae. One week after installation test implants were loaded 5 days/week during 4 weeks. The contra-lateral implants were the unloaded controls. Strain rate was kept constant (1600 micro epsilon/s), while amplitude and frequency were varied per group. Implant stability was followed by resonance frequency analysis. Animals were sacrificed, and ground sections were prepared to rate bone-to-implant contact and bone mass. RESULTS: All implants (n=78) integrated uneventfully. A significant positive effect (p=0.03) of early loading on bone mass was observed in the distal medullar cavity. A significant difference in bone mass between test and control implants was evidenced between the groups (p=0.03 and 0.04). A significant increase in implant stability and bone-to-implant contact could not be shown. CONCLUSIONS: Early controlled stimulation of peri-implant bone is related to amplitude/frequency and not to strain rate as such, considering a constant stimulation time. An increase of bone mass around early-loaded implants was shown. This cortical bone model is most sensitive to low-frequency/high-amplitude stimulation.

The influence of micro-motion on the tissue differentiation around immediately loaded cylindrical turned titanium implants.

OBJECTIVE: The aim of this study was to evaluate the effect of various degrees of implant displacement on the tissue differentiation around immediately loaded cylindrical turned titanium implants. DESIGN: The experiments were conducted in repeated sampling bone chambers placed in the tibia of 10 rabbits. Tissues could grow into the bone chambers via perforations. Due to its double structure, tissues inside the chamber could be harvested leaving the chamber intact. This allowed several experiments within the same animal. The chambers contained a cylindrical turned titanium implant that was loaded in a well-controlled manner. In each of the 10 chambers, four experiments were conducted with the following test conditions: immediate implant loading by inducing 0 (control), 30, 60 and 90 microm implant displacement, 800 cycles per day at a frequency of 1 Hz, twice a week during a period of 6 weeks. Histological and histomorphometrical analyses were performed on methylmethacrylate histological sections. An ANOVA was conducted on the dataset. RESULTS: The total tissue volume was significantly lowest in the unloaded control condition. The bone volume fraction on the other hand, was significantly larger in the unloaded and 90 microm implant displacement, compared to the 30 microm implant displacement. Bone density increased with increasing micro-motion with significantly higher values for the 60 microm- and 90 microm-test conditions compared to the unloaded situation. The chance to have bone-to-implant contact decreased in case of micro-motion at the tissues-implant interface. CONCLUSION: The magnitude of implant displacement had a statistically significant effect on the tissue differentiation around immediately loaded cylindrical turned titanium implants. Implant micro-motion had a detrimental effect on the bone-to-implant contact in an immediate loading regimen.

The immediate rehabilitation by means of a ready-made final fixed prosthesis in the edentulous mandible: a 1-year follow-up study on 50 consecutive patients.

Although a two-stage procedure with symphyseal oral implants can lead to a long-term (15 years) 99% cumulative survival rate, a one-stage approach with immediate loading via prefabricated elements seems to offer a short-term acceptable outcome with significantly lower costs. A series of 50 consecutive patients, not eliminated for any systemic or smoking condition, received at the department of periodontology three implants in the symphyseal area, connected by a very rigid horse shoe-shaped titanium bar. A final screw retained prosthetic framework was placed on top of it at the department of prosthetic dentistry within 2 days after surgery (44) or after a delay, due to purely external factors, of up to 10 days (6). Forty-five patients were followed for 1 year. In one patient, all three implants failed and another four patients were lost to follow-up. The cumulative failure rates for implants and prostheses at 1 year were, respectively, 7.3% and 5%. The mean marginal bone loss at 1 year was 1.08 mm (SD: 1.62; range -5.68 to +2.55). This study shows that stable marginal bone levels can be maintained around immediately loaded implants in the lower jaw in an average patient population for at least 1 year. The survival rate is, however, lower than for a staged approach.

Image-based planning and clinical validation of zygoma and pterygoid implant placement in patients with severe bone atrophy using customized drill guides. Preliminary results from a prospective clinical follow-up study.

The zygoma implant has been designed for those situations where there is insufficient bone in the upper jaw, which would otherwise require onlay or inlay (sinus) bonegrafts. The aim of the study was to present and validate a planning system for implant insertion based on preoperative CT imaging. It allows the surgeon to determine the desired position of different kinds of implants. Finally a customized drill guide is produced by stereolithography. In this study, zygoma, pterygoid and regular platform implants were used. The treatment protocol is validated through 12 case studies, selected at random from the total patient group (n=29 patients). From postoperative images, the exact implant location is determined and the deviation of axes between planned and inserted implants is calculated. In this in vivo study, displacements, varying according to the type of implant and the location of the implants, were observed. From a clinical standpoint, most of the inserted implants were judged to be adequately sited. A prospective clinical follow-up study was performed on all 29 patients. Although all patients presented with severe maxillary atrophy, excellent cumulative survival rates (92%) for the zygoma implants and 93% for regular platform implants have been obtained.

Peri-implant health around screw-shaped c.p. titanium machined implants in partially edentulous patients with or without ongoing periodontitis.

The relationship between periodontitis and peri-implantitis remains a matter of debate. The present study compared, "within" randomly chosen partially edentulous patients (n=84 subjects, 97 jaws), the marginal bone loss around teeth and implants during 5 years (range 3 to 11 years) following the first year of bone remodelling. The patients had all been rehabilitated by means of screw-shape c.p. titanium implants with a machined surface (Brånemark system). During the 5 years observation interval, periodontal parameters (marginal bone and attachment loss, the latter for teeth only) were collected together with data on confounding factors (smoking, oral hygiene, tooth loss). Marginal bone loss was measured through long-cone intra-oral radiographs. The mean "interval" bone loss was significantly (P=0.0001) higher around teeth (0.48+/-0.95 mm) than around implants (0.09+/-0.28 mm). The corresponding data for the "worst" performing tooth (0.99+/-1.25 mm) and implant (0.19+/-0.32 mm) per subject showed the same tendency. Neither attachment nor bone loss around teeth correlated with marginal bone loss around implants. This study indicated that the rate of bone loss around screw-shape c.p. titanium implants with a machined surface (Brånemark system implants) was not influenced by the progression rate of periodontal destruction around the remaining teeth within the same jaw.

A mechanical evaluation of TiO2-gritblasted and Ca-P magnetron sputter coated implants placed into the trabecular bone of the goat: Part 1.

The influence of Ca-P magnetron sputter coated implants on the mechanical anchorage was evaluated in a goat model. Therefore, uncoated and coated screw designed commercially pure titanium TiO2-blasted implants were inserted into the trabecular bone of the femoral condyles of 12 goats. The thicknesses of the coatings were 0.1 micron (CaP-0.1), 1.0 micron (CaP-1) and 4.0 microns (CaP-4). In addition, uncoated TiO2-blasted implants (Ti) were used as control. Evaluation of the interface strength and appearance, using torque test and scanning electron microscopy, was done at implantation periods of 6 and 12 weeks. Although, especially at 6 weeks of implantation, the Ca-P coated implants showed higher failure torque values than the TiO2 blasted implants, the observed differences for type of implant and evaluation period were not significant (P > 0.1). SEM evaluation showed that all implants with failure values of more than 100 N conducted bone growth into their screw threads. In addition, we observed that the fracture plane for the CaP-4 implants was situated at the coating-implant interface or inside the coating. For the CaP-1 and CaP-0.1 the fracture line could not be determined definitely. For the Ti implants, the fracture torque testing resulted in failure at the bone-implant interface. Therefore, we conclude that all implants resulted in a good bonding strength with the surrounding bone. The sputtered Ca-P coatings seemed to improve the initial fixation of the TiO2 blasted implants.

A histological evaluation of TiO2-gritblasted and Ca-P magnetron sputter coated implants placed into the trabecular bone of the goat: Part 2.

The aim of this study was to investigate the synergetic influence of surface topography and chemical composition of oral implant materials on bone response. For the experiment screw designed implants were used. The implants were grit-blasted with TiO2 particles. The implants were left uncoated (Ti) or provided with three different amorphous/crystalline Ca-P magnetron sputter coatings, resp. 0.1 micron (CaP-0.1), 1 micron (CaP-1) and 4 microns (CaP-4), in thickness. The implants were inserted in the medial femoral condyles of 12 goats. Each femur received 2 implants. After implantation periods of 6 and 12 weeks the implants were retrieved and prepared for histological and histomorphometrical evaluation (bone contact and bone mass). The light microscopy revealed that bone response to CaP-4 and CaP-1 implants was similar. For example, after 12 weeks, screw threads were almost completely covered with bone. In contrast to CaP-0.1 and Ti implants, where bone apposition was less pronounced. Histomorphometry demonstrated that the bone-to-implant contact for the CaP-1 and CaP-4 implants was significantly higher (P < 0.05) than for the CaP-0.1 and Ti implants. This difference existed already after 6 weeks and was even enhanced after 12 weeks. The bone mass measurements revealed that only at 12 weeks CaP-4 implants had significantly more bone contact inside the screw threads than non-coated Ti-implants (P < 0.05). Supported by our findings, we conclude that the additional application of a 1-4 microns thick Ca-P magnetron sputter coating can further improve the healing response to surface roughened oral implants placed into trabecular bone.

A 5-year prospective randomized clinical trial on the influence of splinted and unsplinted oral implants retaining a mandibular overdenture: prosthetic aspects and patient satisfaction.

Prosthetic outcome and patient satisfaction were evaluated in order to investigate whether there is a need or advantage to splint two implants in the mandible retaining a hinging overdenture. This study included 36 fully edentulous patients randomly divided into three groups according to the attachment system they received: magnets, ball attachments or straight bars (reference group). None of the implants failed during the whole observation period in any of the groups. After 5 years of observation, the Bar group presented the highest retention capacity and the least prosthetic complications but revealed more mucositis and gingival hyperplasia. Patient satisfaction rated similar for all groups although the Magnet group showed lower retention forces. All patients would repeat the same treatment even though the majority of the Magnet group would prefer a more retentive solution because of limited denture stability.

Predictability of reformatted computed tomography for pre-operative planning of endosseous implants.

OBJECTIVES: To determine the reliability of reformatted 2D-CT for pre-operative planning of implant placement. METHODS: One hundred consecutive partially or fully edentate patients underwent 2-D reformatted CT pre-operative planning and subsequent implant placement. The number, site and size of the implants, the available bone height and anatomical complications were recorded. The pre-operative planning and the outcome at surgery were compared statistically using a percentage agreement and Kendall's correlation coefficient. RESULTS: Agreement between the pre- and intra-operative data was good for the number of implants (60%) and the selected sites (70%). From a total of 416 implants planned, 21 implants could not be placed because of intra-operative findings. Agreement was relatively poor for implant size (44%) and anatomical complications (46%). Kendall's correlation coefficient was highest for the number of implants (0.80) and implant sites (0.81). It was much lower for implant sizes (0.51) and did not reach significance for anatomical complications (0.09). CONCLUSIONS: Reformatted 2D-CT is reliable for the pre-operative assessment of the number and sites of implants in the jaws. It is less predictable for the implant size needed and poor for anatomical complications.

[Success of implants in the moderately resorbed edentate maxilla]. / Het succes van implanteren in de matig geresorbeerde edentate bovenkaak.

In applications of implants in the moderately resorbed maxilla factors such as bone quantity and the loading of the bone are of importance for the prognosis. Long-term studies have shown that for the maxilla the results were less good than for the mandible. The main reason for this is the condition of the bone, especially reduced bone quantity together with a thin corticalis an low bone density. Beside these factors there are also the general negative factors such as rheumatoid arthritis, osteoporosis, smoking and radiotherapy. The prognosis of implant supported prostheses is not primarily determined by the number of implants, but by the condition of the bone and to some extent by the splinting effect of the implants.

Patient evaluation and treatment planning.

Patient evaluation and correct treatment planning are important for the successful outcome of implant supported overdentures. The various stages may be considered as follows. An initial appointment which leads to a diagnosis and to the treatment plan, followed by the confirmation appointment where the patient is informed which is the most appropriate solution to their presenting problem. Prior to implant surgery pre-treatment and diagnostic casts are often required which assist the prosthodontist further in his treatment options. An understanding of the various factors which influence the outcome of implant placement will assist the clinician in the successful prosthetic rehabilitation of the patient.

The rehabilitation of the severely resorbed maxilla by simultaneous placement of autogenous bone grafts and implants: a 10-year evaluation.

The long-term success of Brånemark implants has been previously reported. The success rate of the same implants, when associated with autologous grafts, seemed much less predictable. In the present study it is demonstrated that when these implants are installed in conjunction with an autologous corticocancellous hip graft, either onlay or inlay, the cumulative success rate remains at 95% for individual implants in non-smokers. The short extracorporal time might be an explanation. On the other hand, the same approach in patients with congenital defects or who underwent radiotherapy is deceptive. The use of hyperbaric oxygen may dramatically improve these results.

An animal study on the bone behaviour of Ca-P-coated implants: influence of implant location.

Four different implant materials were installed into the mandibular corner of goats to investigate the trabecular bone response in a mainly unloaded model. The implants were installed using a standardized technique and were left in situ for 12 weeks. One goat had to be sacrificed after surgery because of a broken rib; the other animals healed uneventfully. After sacrifice of the animals, the bone response to the uncoated and the three different Ca-P implants was evaluated histologically and histomorphometrically. Four sections of each implant were evaluated; two were located in the cortical and two in the trabecular bone. Of the 44 retrieved implants, 20 implants appeared to be installed partially in the mandibular canal, as clearly visible on the X-rays. These implants were not used in the histomorphometrical measurements. Histological evaluation showed that the trabecular and cortical bone reactions were similar; there was no significant difference in the percentage of bone contact nor in the amount of bone in contact with the implants. In conclusion this study showed that the mandibular corner is an unsatisfactory model for the installation of implants because of anatomical restrictions. Also, the experiment remained inconclusive about the influence of loading conditions on bone behaviour. Nevertheless, the histological results confirmed the bioactive properties of Ca-P coatings.

Computer-assisted planning of oral implant surgery: a three-dimensional approach.

A planning system for oral implant surgery based on a true three-dimensional approach is described. This system allows the interactive placement and adjustment of axial-symmetric models representing implants in the jawbone structures visible on computerized tomographic volume data. Simultaneous visualization is possible on two-dimensional reformatted images and on three-dimensional-derived bone surface representations. This approach largely outperforms the manual planning practice based on two-dimensional dental computerized tomographic images printed or on film.