Quality of Orthodontic Appliances Manufactured In Dental Labs in Saudi Arabia: A Pilot Study

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1 International Journal Of Healthcare Management VOLUME 2018, ISSUE 04 (April) ISSN: ISSN: (Online) Quality of Orthodontic Appliances Manufactured In Dental Labs in Saudi Arabia: A Pilot Study Al Khanfoor Fai 1, Al Helabi Layla 1, Al Ghamdi Hanan 1, Al Rasheed Maram 1, Dr Eman Fatani 2 1 Dental intern, Riyadh Collages of Dentistry and Pharmacy 2 Lecturer, Department of Orthodontics Riyadh Collage of Dentistry and Pharmacy Abstract Failure of an Orthodontic appliance can be resulted due to multiple factors. Factors influencing the failure of the orthodontic appliance includes clear communication, impression material, and quality assurance. The research aims to determine the causes of poor quality appliances. It also aims to find out appliance having the highest failure rate. This research was conducted using a questionnaire survey. A survey consisting of 27 question was distributed among orthodontist and orthodontic postgraduates in Saudi Arabia. The survey represented that the most common appliance requiring adjustment was Hawley Retainer (52.6%) and the least common appliance requiring adjustment was Essex Retainer (47.4%). The component responsible for most common ill-fit was analyzed and it was found that For Hawley and wrap-around retainers and spring aligners, clasps were the most common problem at (52.6%) and (45.1%) respectively. The potential limitation of this research included fewer responses from the orthodontists, which may be due to few numbers of orthodontists in Saudi Arabia. Poor cooperation in participating the survey in relation to the number of surveys distributed was another limitation of this research. Most of the orthodontists reassured the quality of the cases returned from the lab with visual inspection and accuracy of fit being the most practiced way. Approximately 10% of the appliances fail within the first six months whereas solder joint followed by cement loss at bands and acrylic were the three most common areas of failure. Keywords: Failure, orthodontic appliances, quality assurance, impression. 1. INTRODUCTION Orthodontic appliances play an important role in the treatment process [1]. The orthodontic treatment contributes to improving oral hygiene of individuals by correcting dental irregularities and by reducing the risk of ocular trauma [2]. The orthodontic treatment has been suggested to individuals because of its ability to improve the periodontal status of individuals. The orthodontic impacts are manufactured to facilitate individuals by improving their dental and skeletal problems [2] [3]. Due to this reason, the orthodontic implants need to be manufactured appropriately by selecting most suitable materials [4]. The orthodontic implants are most often manufactured in the laboratories, such that technicians are responsible for the manufacturing of dental implants. The quality of orthodontic implant is also dependent on the appropriateness and quality of the material used for the manufacturing of dental implants. Wide majorities of dental appliances are constructed in laboratories; therefore, there is an increased risk of failure of dental implants [5]. The failure of orthodontic lab appliances represents a challenge in the modern orthodontic practice [6]. The failure of orthodontic implants increases the risk of oral health-related complications; therefore, it is required to take measures for preventing the failure of dental appliances. Similar to the other countries of the world, almost all types of dental implants are manufactured in the Saudi Arabia [7]. Despite using high-quality material and appropriate material for manufacturing dental implants, the rates of failure of dental implants in Saudi Arabia has been increasing by the time. There can be a range of causes of failure of dental appliances, including lack of communication between the orthodontist and lab technician, and poor quality of the type of impression materials [7]. Competent technicians manufacture quality appliance, create the good impression, and assure effective communication between the orthodontist and the technician. It is also essential to analyze the quality of material used for manufacturing dental implants, such that due to inappropriate materials, some of the dental implants are at an increased risk of experiencing failure, as compared to the other appliances [7]. This research aims to highlight the appliance having the highest failure rate. This research further aims to find out the component of the appliance, which is most affected. Page 1

2 2. METHODOLOGY This research was conducted using quantitative research methodology. The quantitative research contributes to the identification of the numerical data, such that the interpretation is carried out by using the statistical methods [8]. The research conducted by Moser and Kalton [9] also mentioned that the quantitative research is considered as the reliable mode of inquiry as compared to other methods. The survey research assists in obtaining information describing the characteristics of the large sample of individuals of interest quickly. The survey research assists in acquiring the demographic details and the responses of research participants about the area of interest simultaneously [10]. This research was performed by recruiting Orthodontists in Saudi Arabia. Data Collection Tool A two-sectioned self-administered survey was conveyed specifically to orthodontists across Saudi Arabia. The first section involved the demographic data of the orthodontists related to their position, workplace, and years of experience. The second section composed 27 questions that included the protocols of quality assurance, orthodontic appliances deterioration rate, and deterioration causes of every specific appliance. The questionnaire was conducted using survey monkey software and distributed via social media platforms, s through Saudi Orthodontic Society (SOS), and by direct communication with the orthodontists. Statistical Analysis The data analysis for this research was carried out by using Statistical package for social sciences (SPSS) version 22. Chisquare test was used to find the association between variables related to quality and demographics. It was found that P-value was less than 0.05, which presented the presence of no statistical significance. Data were also analyzed using univariate analysis, which is the most suitable method for describing and summarizing the data. 3. ETHICAL APPROVAL Ethical approval for this research was taken from the Institutional Review Board in Riyadh Colleges of Dentistry and Pharmacy and was granted the registration number (FUGRP/2016/220) and IRB approval number (RC/IRB/2016/359) Postgraduate Workplace Government Private Both Years of experience 1-3 years years > 6 years The research participants were also asked about their area of residence. It was found that about two-thirds (66.7%) of the respondents were from Riyadh city. In response to the question related to the area of fabrication, it was found that majority of orthodontists (38.6%) reported using in-house, followed by outside (33.3%) and both (28.1%) laboratories (Figure 1). Figure 1: Location of Fabrication of Orthodontic Appliances The majority (84.2%) reported that laboratory technicians make the appliance in the in-house laboratories. In response, the question about the type of impression material, about 43.9% reported that impressions are poured before being sent to the lab. It was also found that 96.5% of the respondents have been using standard alginate material, followed by PVS (91.2%) and digital scan (87.7%). In addition, about 80.7% of orthodontists check the case for quality assurance before it is sent out to the lab (Figure 2). 4. RESULTS The first part of this survey included the demographic details of the research participants. It was found that most responses were obtained from orthodontists working in private sector with more than 6 years of experience as shown in Table 1. Table 1. Demographic Characteristics of Orthodontists Frequency (n) Percent (%) Position Consultant Specialist Figure 2: Quality Assurance The process of quality assurance for dental implants includes the assessment of a range of aspects. The research participants Page 2

3 were asked to provide their responses to the essential method of quality assurance. About 93% of the respondents declared that assuring that bands are seated in the appropriate manner is essential for quality assurance. In addition, about 64.9 % of respondents believe that checking lab slip prescriptions for accuracy was most essential. About 52.6% mentioned that sketching the appliance design on the model or lab slip is crucial for quality assurance (Figure 3). Figure 3: Quality Assurance of Outgoing Lab Cases The respondents were also asked about the method, which has been used by them for assuring the quality of outgoing lab cases. It was found that when bands are required in the appliance, 96.5% of respondents fit them in the office and 80.7% send to the lab with bands secured and seated in impression. In addition, about 87.7% of orthodontists reported that they check quality assurance of lab cases being returned, with visual inspection and accuracy of fit being the most common procedure at 84.2% (Figure 4). select laboratory by considering the price of appliance whereas, 12.3% mentioned that they make decisions by considering the location of the lab. The estimated percentage of lab cases sent in Saudi Arabia versus out of Saudi Arabia ranged from 5-100% and 0-80%, with the most common answer being 100% and 0% respectively. It was found that the about 61% use PVS impression material and 39% send the stone model to ensure against impression distortion when sending to an out of state lab. The respondents were also asked to estimate the percentage of appliances that fit correctly on the first try. The answers provided by the respondents ranged from 5-100%, such that the most common answer was 80%. The respondents were asked to mention the appliances requiring adjustments. In the light of responses provided by respondents, it was found that the most common appliance to need an adjustment was the Hawley retainer (52.6%) and the least common appliance needing adjustment was the Essix retainer (47.4%). Respondents were asked which component of each appliance was most commonly responsible for an illfit (Table 2). For Hawley and wrap-around retainers and spring aligners, clasps were the most common problem, which was mentioned by approximately 52.6% and 45.1% respondents respectively. About 40.4 % of respondents declared that ill-fitting Essix retainers had poor posterior seating; about 38.6 % mentioned that gingival impingement (38.6%). Bands were an issue in 51% of RPE cases and 56% of fixed functional cases. Space maintainer cases had a close tie for stabilizing wire/lingual arch (43.9%) and bands (42.1%). For positioners, 51% cited poor seating as the most ill-fitting component. In removable functional appliances (i.e. Bionator, Twin Block), the acrylic ramp was cited at 60.8%. The research participants were asked to mention the frequency of appliances, which might fail or break within the first six months. A wide majority of respondents mentioned 10% chances of breaking of appliances; however, answers ranged from 1-80%. The three most common areas of failure or breakage were solder joint (61.4%), cement loss at bands (19.3%), and acrylic (14%). Table 2: Component Most Responsible for Ill-Fitting Appliances Figure 4: Quality Assurance of Incoming Lab Cases The respondent was also asked whether one laboratory could be used for making all dental appliances. It was found that about 61.4% orthodontists use one lab exclusively. On the other hand, remaining approximately 38.6% select lab based on the type of appliance needed. Approximately 21.1 % of respondents declared that they select laboratory because of the date required for selection of appliances and the turnaround time. Approximately 17.5% respondents mentioned that they Appliance Component Response (%) Hawley and Clasps 52.6 wrap-around retainer Essix retainer Posterior seating 40.4 Space Stabilizing 43.9 Maintainer wire/lingual arch Positioner Seating 51.0 Spring aligner Clasps 45.1 RPE Bands 51.0 Removable functional Acrylic guides 60.8 Page 3

4 appliance Fixed functional appliance Bands/Crowns DISCUSSION The researcher acquired responses from less number of an orthodontist, which may be due to few numbers of the orthodontist in Saudi Arabia. In addition, the less number of respondents might also be due to lack of interest of orthodontists. The orthodontic companies in Saudi Arabia have been manufacturing a range of appliances making it difficult for the orthodontist to remain up-to-date. Some orthodontist commented that they have not come across the number of appliances mentioned in the survey and therefore, had limited their responses to survey questions. A recent increase in the demands for orthodontic treatment and availability of more postgraduate programs has expanded the orthodontic specialty. Unfortunately, the laboratories, which have been manufacturing dental implants, are not up-todate. In addition, shortage of competent and unavailability of well-trained orthodontic technicians also suppresses the quality of dental implants. However, most commonly, the orthodontists suffer from the absence of specialized orthodontic labs. Considering the impression materials, Alginate and PVS are the most materials used by orthodontists, such that approximately 96.5%- 91.2% orthodontists use these materials, rather than digital scanners. Alginate and PVS impressions have some unfavorable conditions, which can affect the quality of the appliances. For example, these materials need to be poured immediately to avoid dimensional changes, poor tear strength, voids, and bubbles [11]. However, use of different methods in the disinfection may affect the quality of impressions [12]. For improving diagnosis and treatment planning, it is recommended to use intraoral digital scanners in orthodontic clinics with direct submission to laboratories, in order to improve the accuracy of appliances. The use of digital scanners is also likely to reduce the number of appointments, increase patient satisfaction and might also result in less apprehension [11]. The implementation of quality assurance policy will ensure better appliance fit. The efficient quality assurance guarantee meeting the standards and reveal errors at the early stage, which is cost effective and time-saving [13][14]. The majority of the responses regarding in-house lab reported that 84.2% made by lab technician which is a true advantage over traditional dental offices. The in-house labs offer direct communication with the technician constructing the appliance and also provides the opportunity for the direct pouring of impression material. Checking the quality of the appliance becomes easier by both the orthodontist and technician in the same clinic with the presence of the patient. 6. CONCLUSION The research aimed to determine the causes of poor quality dental appliances in Saudi Arabia and to find out appliance having the highest failure rate. The responses of research participants declared that most of the orthodontists reassured the quality of the cases returned from the lab. It was also found that visual inspection and accuracy of fit were practices by a wide majority of orthodontists. The responses of research participants also declared that Essix retainer was the least common appliance requiring adjustment. On the contrary, the orthodontists declared that Hawley retainer was the most common appliance needing adjustment. This research also found out the causes due to which the appliances require adjustments. Clasps were recognized as the most common cause of the ill-fitting of Hawley and Wraparound retainers and the spring aligners. The respondents declared that approximately 10% of the appliances fail within the first six months. In addition, it was also mentioned that solder joint, the cement loss at bands and acrylic were the three most common areas of failure of dental appliances. 7. REFERENCES [1] Pruzansky, D. P., & Park, J. H. (2016). Quality of Lab Appliances in Orthodontic Offices. Journal of Clinical Pediatric Dentistry, 40(6), [2] Boke, F., Gazioglu, C., Akkaya, S., & Akkaya, M. (2014). The relationship between orthodontic treatment and gingival health: A retrospective study. European journal of dentistry, 8(3), 373. [3] Fathian, M., Kennedy, D. B., Nouri, R. M., & Ped, D. (2007). Laboratory-made space maintainers: a 7-year retrospective study from private pediatric dental practice. Pediatric dentistry, 29(6), [4] Rajah, L. D. (2002). Clinical performance and survival of space maintainers: Evaluation over a period of 5 years. Journal of Dentistry for Children, 69(2), [5] Kim, J., Heo, G., & Lagravère, M. O. (2013). 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