Implant survival rate and marginal bone loss of 174 implants with different variables associated over a minimum observational period of 20 years: A retrospective study.

PURPOSE: To investigate the long-term implant survival rate and marginal bone loss (MBL) of implants with different variables associated over an observational period of at least 20 years. MATERIALS AND METHODS: Patients with at least one implant placed prior to 2001 were recalled and visited. Data on implant macro-design, prosthetic aspects, site distribution, and patient-related factors were collected. MBL was evaluated on intraoral X-rays and peri-implant soft tissue parameters were recorded. The patients were asked to fill out a questionnaire to evaluate their satisfaction with the treatment received. Descriptive statistics indicators were estimated. Analysis of variance and analysis of covariance models were used to investigate any differences in the MBL and peri-implant probing depth (PPD) among the variables. A chi-square analysis was performed to investigate any association between different types of prosthetic implant-supported rehabilitations and survival/success outcomes. RESULTS: Forty-one (41) patients and 174 implants were included with a mean observational period of 23.3 ± 2.8 years. The implant survival and success rates were 96.5% and 83.3% respectively, while 3.5% of early failures were detected. The lowest success rates were observed for implants supporting fixed full-arch rehabilitations (71.05%) and overdenture rehabilitations (86.11%). A mean MBL of 1.81 ± 0.71 mm and a mean PPD of 3.38 ± 1.62 mm were recorded. The interaction between the collected data with MBL and PPD did not reveal any statistically significant differences between the variables (p > 0.05). A statistically significant difference was recorded when analyzing the association between the different types of prosthetic implant-supported rehabilitations and success rates (p = 0.014), with fixed and removable full-arch rehabilitations presenting with lower success rates. Answers to the questionnaire showed a generally high level of satisfaction. CONCLUSIONS: Within the limits of this retrospective study and based on the results, an implant survival rate higher than 96% was observed after a mean observational period of 23.3 ± 2.8 years. Both the implant survival rate and MBL seemed stable after a mean observational period of 23.3 ± 2.8 years. Implants supporting fixed and removable full-arch rehabilitations seemed to present lower success rates over time. Implant rehabilitation seemed to provide patients with optimal long-term outcomes in terms of functional and psychological aspects.

Roughness and SEM Analysis of Manual and Ultrasonic Instrumentation over Different Crown Materials for Dental Implants Restorations.

The use of new prosthetic materials makes it necessary to establish adequate hygienic protocols. It was decided to make prosthetic crowns from four different materials: composite, lithium disilicate, metal ceramic, and zirconium, and to evaluate the effects on the surfaces of four different instruments through SEM and roughness analysis: manual steel curette, manual titanium curette, ultrasonic steel insert, and ultrasonic peek insert. Forty crowns were made, ten of each type of material. For each material, five crowns were manually instrumented with steel inserts (curette 11-12, PDT, Missoula, MT, USA) and titanium (Wingrove 3-4, PDT, Missoula, MT, USA) on the lingual and buccal surfaces, respectively, and the other five crowns were instrumented with an ultrasonic peek insert (ICS-IC1, Mectron, Carasco, Italy) on the buccal surface and steel (PS, EMS, Nyon, Switzerland) on the lingual surface. At this point, surface roughness analysis was carried out. The data were analyzed with a Kolmogorov-Smirnov test. Therefore, it was decided to conduct two analyses with a Kruskal-Wallis test and Bonferroni post hoc test. Then, the instrumented crowns were analyzed by SEM. The analysis of the data shows that the highest average roughness was within the composite group, while the best material appeared to be disilicate. Significant differences existed between the groups, between the materials, and between the different instruments (p-value < 0.05). In the qualitative analysis carried out by SEM, the classic steel insert eliminated the residues of golden finishing. The peek insert created alterations on all tested surfaces. The steel curette did not create particular problems, with the exception of zirconium, where it was possible to observe some scratch lines. Instrumentation with the titanium curette created deeper incisions than the steel curette in the composite and disilicate. The best results came from the ultrasonic steel insert, while the best material appeared to be disilicate.

Biomolecular, Histological, Clinical, and Radiological Analyses of Dental Implant Bone Sites Prepared Using Magnetic Mallet Technology: A Pilot Study in Animals.

BACKGROUND: A new instrumentation exploiting magneto-dynamic technology (mallet) proposed for implant site preparation was investigated. METHODS: In the tibias of three minipigs, two sites were prepared by mallet and two by drill technique. Primary stability (ISQ) was detected after implant positioning (T0) and at 14 days (T14). X-rays and computed tomography were performed. At T14, bone samples were utilized for histological and biomolecular analyses. RESULTS: In mallet sites, histological evaluations evidenced a significant increase in the newly formed bone, osteoblast number, and a smaller quantity of fibrous tissue. These results agree with the significant BMP-4 augmentation and the positive trend in other osteogenic factors (biological and radiological investigations). Major, albeit IL-10-controlled, inflammation was present. For both techniques, at T14 a significant ISQ increase was evidenced, but no significant difference was observed at T0 and T14 between the mallet and drill techniques. In mallet sites, lateral bone condensation was observed on computed tomography. CONCLUSIONS: Using biological, histological, clinical, and radiological analyses, this study first shows that the mallet technique is effective for implant site preparation. Based on its ability to cause osseocondensation and improve newly formed bone, mallet technology should be chosen in all clinical cases of poor bone quality.

Role of rhBMP-7, Fibronectin, And Type I Collagen in Dental Implant Osseointegration Process: An Initial Pilot Study on Minipig Animals.

BACKGROUND: The biological factors involved in dental implant osseointegration need to be investigated to improve implant success. METHODS: Twenty-four implants were inserted into the tibias of six minipigs. Bone samples were obtained at 7, 14, and 56 days. Biomolecular analyses evaluated mRNA of BMP-4, -7, Transforming Growth Factor-ß2, Interleukin-1ß, and Osteocalcin in sites treated with rhBMP-7, Type 1 Collagen, or Fibronectin (FN). Inflammation and osteogenesis were evaluated by histological analyses. RESULTS: At 7 and 14 days, BMP-4 and BMP-7 increased in the sites prepared with rhBMP-7 and FN. BMP-7 remained greater at 56 days in rhBMP-7 and FN sites. BPM-4 at 7 and 14 days increased in Type 1 Collagen sites; BMP-7 increased from day 14. FN increased the TGF-ß2 at all experimental times, whilst the rhBMP-7 only did so up to 7 days. IL-1ß increased only in collagen-treated sites from 14 days. Osteocalcin was high in FN-treated sites. Neutrophilic granulocytes characterized the inflammatory infiltrate at 7 days, and mononuclear cells at 14 and 56 days. CONCLUSIONS: This initial pilot study, in a novel way, evidenced that Type 1 Collagen induced inflammation and did not stimulate bone production; conversely FN or rhBMP-7 showed neo-osteogenetic and anti-inflammatory properties when directly added into implant bone site.

Piezoelectric bone surgery compared with conventional rotary instruments in oral surgery and implantology: Summary and consensus statements of the International Piezoelectric Surgery Academy Consensus Conference 2019.

PURPOSE: Piezoelectric bone surgery was introduced into clinical practice almost 20 years ago as an alternative method for cutting bone in dental surgical procedures, in an attempt to reduce the disadvantages of using conventional rotary instruments. The aim of this Consensus Conference was to evaluate the current evidence concerning the use of piezoelectric surgery in oral surgery and implantology. MATERIALS AND METHODS: Three working groups conducted three meta-analyses with trial sequential analysis, focusing on the use of piezoelectric surgery in impacted mandibular third molar extraction, lateral sinus floor elevation and implant site preparation. The method of preparation of the systematic reviews, based on comprehensive search strategies and following preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, was discussed and standardised. RESULTS: Moderate/low evidence suggests that piezoelectric surgery is significantly associated with a more favourable postoperative course (less pain, less trismus) after impacted mandibular third molar extraction than conventional rotary instruments. Moderate evidence suggests that implants inserted with piezoelectric surgery showed improved secondary stability during the early phases of healing compared with those inserted using a drilling technique. Strong/moderate evidence suggests that piezoelectric surgery prolongs the duration of surgery in impacted mandibular third molar extraction, sinus floor elevation and implant site preparation, but it is unclear whether the slight differences in duration of surgery, even if statistically significant, represent a real clinical advantage for either operator or patient. Weak evidence or insufficient data are present to draw definitive conclusions on the other investigated outcomes. CONCLUSIONS: Further well-designed trials are needed to fully evaluate the effects of piezoelectric surgery, especially in implant site preparation and sinus floor elevation.

In Vitro Simulation of Dental Implant Bridges Removal: Influence of Luting Agent and Abutments Geometry on Retrievability.

Implant fixed dental prostheses are widely used for the treatment of edentulism, often preferred over the screw-retained ones. However, one of the main features of an implant-supported prosthesis is retrievability, which could be necessary in the case of implant complications. In this study, the retrievability of implant-fixed dental prostheses was investigated considering two of the main factors dental practitioners have to deal with: the abutments geometry and the luting agent. Impulsive forces were applied to dental bridge models to simulate crowns' retrievability in clinical conditions. The number of impulses and the impulsive force delivered during each test were recorded and used as retrievability indexes. One-hundred-and-five tests were conducted on 21 combinations of bridges and luting agents, and a Kruskal-Wallis test was performed on the results. The abutment geometry significantly influenced the number of impulses needed for retrieval (p < 0.05), and a cement-dependent trend was observed as well. On the other hand, the forces measured during tests showed no clear correlation with bridge retrievability. The best retrievability was obtained with long, slightly tapered abutments and a temporary luting agent.

Piezoelectric bone surgery for implant site preparation compared with conventional drilling techniques: A systematic review, meta-analysis and trial sequential analysis.

PURPOSE: To evaluate whether the use of piezoelectric bone surgery (PBS) for implant site preparation reduces surgical time, improves implant stability, preserves marginal bone level and improves the survival rate of oral implants compared with conventional drilling techniques. MATERIALS AND METHODS: This meta-analysis followed the PRISMA (preferred reporting items for systematic review and meta-analysis) guidelines and was registered in the PROSPERO (international prospective register of systematic reviews) database (CRD42019142749). The PubMed, Embase, Scopus and Open Grey databases were screened for articles published from 1 January 1990 to 31 December 2018. The selection criteria included randomised controlled trials (RCTs) and case-control studies (CCTs) comparing the PBS with conventional rotary instruments for implant site preparation, and reporting any of the selected clinical outcomes (surgical time, implant stability, marginal bone variations and implant failure rate) for both groups. The risk of bias assessment was performed using the Cochrane Collaboration tool for RCTs and the Newcastle-Ottawa scale (NOS) for CCTs. A meta-analysis was performed, and the power of the meta-analytic findings was assessed by trial sequential analysis (TSA). RESULTS: Eight RCTs and one CCT met the inclusion criteria and were included in the review. The meta-analysis and the TSA showed moderate evidence suggesting that the PBS prolongs surgery duration and improves secondary stability 12 weeks after implant placement compared with conventional drilling techniques. Insufficient data are available in literature to assess if the PBS reduces marginal bone loss and/or improves the implant survival rate compared with conventional drilling techniques. CONCLUSIONS: Adequately powered randomised clinical trials are needed to confirm the PBS positive effect on the secondary stability and to draw conclusions about the influence of PBS on marginal bone stability and implant survival.

In Vitro Impact Testing to Simulate Implant-Supported Prosthesis Retrievability in Clinical Practice: Influence of Cement and Abutment Geometry.

Cement-retained implant-supported prosthetics are gaining popularity compared to the alternative screw-retained type, a rise that serves to highlight the importance of retrievability. The aim of the present investigation is to determine the influence of luting agent, abutment height and taper angle on the retrievability of abutment-coping cementations. Abutments with different heights and tapers were screwed onto an implant and their cobalt-chrome copings were cemented on the abutments using three different luting agents. The removals were performed by means of Coronaflex®. The number of impulses and the forces were recorded and analyzed with a Kruskal-Wallis test. Harvard cement needed the highest number of impulses for retrieval, followed by Telio CS and Temp Bond. However, abutment height and taper showed a greater influence on the cap's retrievability (p < 0.05). Long and tapered abutments provided the highest percentage of good retrievability. The influence of the luting agent and the abutment geometry on the cap's retrieval performed by Coronaflex® reflects data from literature about the influence of the same factor on the maximum force reached during uniaxial tensile tests. The impulse force was slightly affected by the same factors.

Piezoelectric implant surgery and immediate loading in the aesthetic zone.

BACKGROUND: Replacement of missing teeth in the anterior aesthetic zone has challenged clinicians with fixed, removable or implant prosthodontics. Problems have been encountered could void aesthetic and functional results. The aim of this study was to present a clinical case report in which clinician challenged a very strong aesthetic case with an innovative surgical and prosthetic approach. METHODS: A patient who presented to the authors with a maxillary central incisor that had a hopeless prognosis secondary to acute localized severe periodontitis. The patient was treated by extracting the tooth and replacing it immediately with a platform switched implant using piezoelectric surgery. The implant was then restored with an immediate, non-occlusal loading provisional restoration. RESULTS: The implant became osseointegrated and was ultimately restored with a definitive abutment and crown restoration. CONCLUSIONS: Innovative approaches could represent a valid alternative to restore patients functionally and aesthetically.

A 4-Year Retrospective Radiographic Study of Marginal Bone Loss of 156 Titanium Implants Placed with Ultrasonic Site Preparation.

This retrospective study evaluated implant survival rate (SR) and marginal bone loss around dental implants placed with ultrasonic implant site preparation. A total of 156 implants were placed in 28 totally and partially edentulous patients. Bone loss was measured on intraoral paralleling digital radiographs taken at the impression phase and after 4 years of loading. As 3 implants (1.92%) failed at the second surgery stage, the SR was 98.08% after 4 years. The mean marginal bone loss was 0.52 ± 0.33 mm (0.51 ± 0.35 mm mesially and 0.53 ± 0.35 mm distally), with comparable values for implants inserted into the maxilla (0.52 ± 0.32 mm) and the mandible (0.52 ± 0.35 mm).

Immediate Loading of Implant-Supported Single Crowns after Conventional and Ultrasonic Implant Site Preparation: A Multicenter Randomized Controlled Clinical Trial.

AIM: To compare implant survival rate and marginal bone loss (MBL) of immediately loaded single implants inserted by using ultrasonic implant site preparation (UISP) (test) and conventional rotary instrumentation (control). METHODS: Two single implants were inserted for each patient: after randomization, test site was prepared by using an ultrasonic device (Piezosurgery Touch, Mectron, Italy) and control site was prepared by using the drills of the selected implant system (Premium AZT, Sweden & Martina, Italy), until reaching a final diameter of 3 mm in both groups. Identical implants (3.8x11.5 mm) were inserted in all sites at crestal level. Impressions were taken and screwed resin single crowns with platform-switched provisional abutments were delivered with 48 hours. Periapical radiographs were taken at provisional crown insertion (T0), 6 months (T1) and one year (T2) after prosthetic loading to measure MBL. All data were tested for normality and subsequently analyzed by paired samples t-test and forward multiple linear regression. RESULTS: Forty-eight patients were treated in six centers with the insertion of ninety-six implants (48 test; 48 control). Four implants in four patients failed within the first six months of healing (two in test group; two in control group; no difference between groups). Forty patients (age 60.1±10.7 years; 22 female, 18 male) were included in the final analysis. Mean MBL after six months of loading was 1.39±1.03 mm in the test group and 1.42±1.16 mm in the control group (p>0.05) and after one year was 1.92±1.14 mm and 2.14±1.55 mm in test and control, respectively (p>0.05). CONCLUSIONS: No differences in survival rate and MBL were demonstrated between UISP and conventional site preparation with rotary instruments in immediately loaded dental implants: UISP, with its characteristics of enhanced surgical control and safety in proximity of delicate structures, may be used as a reliable alternative to the traditional drilling systems.

Reliability, Learnability and Efficiency of Two Tools for Cement Crowns Retrieval in Dentistry.

BACKGROUND: Tooth-supported fixed dentures are commonly used in restorative dentistry, and have definitely reached a high survival rate; nevertheless, their removal is sometimes required mainly due to caries or other failures (poor fit, poor cementation and so on). Removing a definitive partial denture is not trivial since the used cement is not always known and it may be very resistant; additionally, there are various clinical circumstances in which a conservative disassembly would be desirable. OBJECTIVE: assessing the performance of different tools for cement crowns retrieval in terms of reliability, learnability and efficiency. METHODS: An experimental study has been performed on two different devices for conservative crown/bridge removal: a manual tool that is a sliding hammer, and an automatic tool, powered by compressed air. Both skilled and unexperienced operators have been considered and an experimental set up has been appositely designed in order to measure force versus time patterns. The peak applied force has been taken as an output variable for the evaluation of tool performance. RESULTS: The automatic tool improves both the inter-operator and the intra-operator reliability, respectively from 79% to 95%, and from 69% to 92%. Additionally, the force pattern is significantly different between these two tools: the instrument powered by compressed air, produces a sharper peak force, as required to break fragile materials such as dental crown cement, and its efficiency can be estimated to be 75% higher. Both tools have a high learnability since the performances of experienced and unexperienced operators have not proved to be significantly different. CONCLUSION: A methodology has been set up to compare tools for cement crowns retrieval. The compressed-air tool has been proved to generally provide a better performance unless more ductile cement is to be broken.

Method to improve passive fit of frameworks on implant-supported prostheses: An in vitro study.

STATEMENT OF PROBLEM: The passivity of the superstructure to the abutments of implant-supported prostheses is necessary for implant-prosthesis success. Improvements are needed in the methods of verifying passivity. PURPOSE: The purpose of this in vitro study was to evaluate an inexpensive, easy to make, and user-friendly device to verify the position of the implant abutment replicas of the definitive cast and to avoid framework misfit before fabrication. MATERIAL AND METHODS: Eighty stone devices were constructed on a metal base for the in vitro tests. The horizontal, vertical, and angled positions of the implant replicas were created to simulate misfits. The devices were fitted on the abutment replicas, and their ability to identify misfits was evaluated. A statistical analysis was not indicated, because the probability of fracture of the stone devices was 0 or 1. Two mathematical models were built using computer-aided design software (SolidWorks Premium; Dassault Systèmes SolidWorks Corp), and the finite element method was used (Ansys; ANSYS Inc) to simulate the structural behavior of 2 implant configurations (4 and 6 implants). RESULTS: Horizontal misfits of 150 µm, vertical misfits of 50 µm, and angled misfits of 1 degree were detected during the in vitro tests. Different loads and bone quality in the mathematical models did not change stress in the prosthesis configurations on 4 or 6 implants in a relevant way. CONCLUSIONS: The fabricated device was easily able to detect the misfits in accordance with the defined parameters.

In vitro standardization of two different removal devices in cemented implant prosthesis.

OBJECTIVES: The purpose of this study was to describe the force generated by two different removal devices used to retrieve cemented crowns on implant abutments. The influence of six different operators was evaluated. MATERIAL AND METHODS: Three replicated Coronaflex(®) (Kaltenbach & Voigt GmbH, KaVo Dental GmbH) and reverse hammer setups were tested. The experimental setup has employed a screw bearing a diametral hole through which a loop holder passed. The screw was attached to a force transducer (Brüel & Kjaer, type 8201), and the loop holder arm was kept perpendicular to the transducer axis. The results were statistically evaluated with ANOVA. RESULTS: The operator has resulted to play significant influence with reference to reverse hammer (coefficient of variation 43.3%) rather than with Coronaflex(®) (9.8%). Evaluating every single operator, more variation can still be found by considering each reverse hammer (37.5%) rather than each Coronaflex(®) (8.8%). CONCLUSION: Coronaflex(®) device was found to systematically reach a more repeatable and higher peak amplitude of forces compared with reverse hammer, both by experienced and inexperienced operators.

Transglutaminase 2 May Be Associated with Peri-implant Gingival Overgrowth: Preliminary Assessments.

UNLABELLED: Tissue transglutaminase 2 (TG2) is ubiquitously expressed in normal tissues and plays an important role in the pathophysiology of wound healing. An increase in periodontal tissues has been previously reported in cyclosporine-induced gingival overgrowth. PURPOSE: The aim of this study was to explore associations between TG2 expression and the vascularization and maturation processes of peri-implant soft tissues over time. MATERIALS AND METHODS: Edentulous patients proposed for mandibular implant-retained overdentures were included in the study. Biopsies of the peri-implant mucosa were performed at the first surgical stage and at 4, 8, and 12 months after prosthetic load. A follow-up program was directed to record plaque indexes, bleeding on probing data, and pocket probing depth around implants. An evaluation of the vessels' density was carried out by digital virtual microscopy and using an immunohistochemistry approach (antibodies anti-CD31, anti-TG2). A robust multivariable regression model was implemented. RESULTS: According to model results, blood vessel count and probing (as a marker of gingival overgrowth in absence of plaque) significantly decrease over time and are associated with TG2, particularly for values above the median. CONCLUSION: The association of an increased TG2 expression in the extracellular matrix might have a significant impact in the development of gingival overgrowth around a loaded implant.

An alumina toughened zirconia composite for dental implant application: in vivo animal results.

Ceramic materials are widely used for biomedical applications because of their remarkable biological and mechanical properties. Composites made of alumina and zirconia are particularly interesting owing to their higher toughness with respect to the monolithic materials. On this basis, the present study is focused on the in vivo behavior of alumina toughened zirconia (ATZ) dental implants treated with a hydrothermal process. A minipig model was implemented to assess the bone healing through histology and mRNA expression at different time points (8, 14, 28, and 56 days). The novel ATZ implant was compared to a titanium clinical standard. The implants were analyzed in terms of microstructure and surface roughness before in vivo tests. The most interesting result deals with a statistically significant higher digital histology index for ATZ implants with respect to titanium standard at 56 days, which is an unprecedented finding, to the authors' knowledge. Even if further investigations are needed before proposing the clinical use in humans, the tested material proved to be a promising candidate among the possible ceramic dental implants.

A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal.

PURPOSE: The surgical removal of mandibular third molars is frequently accompanied by significant postsurgical sequelae, and different protocols have been described to decrease such adverse events. The aim of this study was to investigate the performance of piezosurgery compared with traditional rotating instruments during mandibular third molar removal. PATIENTS AND METHODS: A single-center, randomized, split-mouth study was performed using a consecutive series of unrelated healthy patients attending the Oral Surgery Unit of the University of Turin for surgical removal of bilateral mandibular third molar teeth. Each patient was treated, at the same appointment, using bur removal on 1 side of the mandible and a piezoelectric device on the contralateral side. The primary outcomes reported were postoperative pain, objective orofacial swelling, and surgical duration; secondary outcomes were gender, age, and possible adverse events. Analysis of variance or paired t test was used as appropriate to test any significant differences at baseline according to each treatment subgroup, and categorical variables were analyzed by χ(2) test. RESULTS: The study sample consisted of 100 otherwise healthy patients. The mean pain evaluation reported by patients who underwent surgery with piezosurgery was significantly lower than that reported after bur (conventional) removal, reaching statistical difference after 4 days (P = .043). The clinical value of orofacial swelling at day 7, normalized to baseline, was lower in the piezosurgery group (P < .005). The average surgical duration was significantly shorter in the bur group than in the piezosurgery group (P < .05). Three patients having bur removal developed short-term complications (2 dry sockets and 1 temporary paraesthesia), which totally resolved by 4 weeks. CONCLUSIONS: To date, this prospective investigation is the largest reported split-mouth study on piezosurgery for lower third molar tooth removal. This study also compared surgeons with different degrees of experience. It is evident that using a piezoelectric device can enhance the patient experience and decrease postoperative pain and swelling.

Ultrasonic implant site preparation using piezosurgery: a multicenter case series study analyzing 3,579 implants with a 1- to 3-year follow-up.

This multicenter case series introduces an innovative ultrasonic implant site preparation (UISP) technique as an alternative to the use of traditional rotary instruments. A total of 3,579 implants were inserted in 1,885 subjects, and the sites were prepared using a specific ultrasonic device with a 1- to 3-year follow-up. No surgical complications related to the UISP protocol were reported for any of the implant sites. Seventy-eight implants (59 maxillary, 19 mandibular) failed within 5 months of insertion, for an overall osseointegration percentage of 97.82% (97.14% maxilla, 98.75% mandible). Three maxillary implants failed after 3 years of loading, with an overall implant survival rate of 97.74% (96.99% maxilla, 98.75% mandible).

A method to improve passive fit of frameworks on implant-supported prostheses: an in vivo study.

PURPOSE: A die stone jig was evaluated as to its ability to clinically verify the position of the abutment replicas on the master cast. MATERIALS AND METHODS: A clinical evaluation was made on 58 edentulous arches necessitating rehabilitation with fixed partial dentures. Any broken jigs detected were replaced with a new set of jigs and clinically retested. Data were statistically confirmed. RESULTS: Fifty-five percent of the 58 jigs broke, with a 95% confidence interval (CI) of 42.5 to 67.3; after replacement, there were no breakages (95% CI: 0 to 6.2). CONCLUSIONS: The jig detected misfits in clinical trials, according to the parameters defined in the literature.