Orthodontic practice from a clinical point of view is widely influenced by numerous factors. The shift in treatment seeking for a dynamic change in the esthetics especially in adults have created a necessity for treatment modalities which has less compromise in an individual lifestyle during the course of treatment.[5]
H D Kesling, considered as the pioneer in the field of aligners, was the first to use a flexible tooth positioning appliance in order to achieve tooth movement by preventing the use of visible wires, brackets or other metallic aids. [15]
Aligners have greater aesthetic qualities, superior formability and effortless to use. The vital material properties such as large springback, reduced stiffness, excellent formability, large energy storage, biocompatibility and stability in varied environment are deemed necessary.[4]
Efficacy of tooth movement with clear thermoplastic appliances was also lower than fixed appliances. [4, 16] Aligners being the most looked upon by the current patient generation has numerous shortcomings, though advancement in technology is aimed in improving the material properties and its applicability in clinical practice.[1, 5]
Thermoplastic polymers have inherent limitations associated with thermoplastic polymer materials such as structural instability, low tensile strength, and low wear resistance.[3]
The force produced by thermoplastic appliances for orthodontic tooth movement is mainly driven by the material, thickness and the degree of activation.[10]
In the present study we have used high pressure thermoforming machine – Biostar Thermoforming machine (Model: 2014). This machine was selected owing to better adaptation of the thermoplastic sheet during thermoforming. Wolfram Hahn et al[17] carried out a study focusing on thermoplastic aligners, where higher force delivered by the appliance was due to better fit of the appliance which was achieved in pressure thermoforming machine compared to the force delivered by vacuum thermoformed appliance.[17]
Jeong-Hyun Ryu et al[5], Tamburrino F et al[1] in their study evaluated the mechanical properties of thermoplastic polymer sheets after thermoforming on standard, predetermined models with predetermined shapes. In the literature, several studies revealed a statistically significant difference existed in their mechanical properties.[1, 5, 13, 18–22] Even if the tests were performed under standardized conditions, examining the samples in a preset shape and then drawing conclusions about their properties will be less important for therapeutic purposes.
In the current investigation, we have used pre-treatment and post-treatment maxillary models of a same patient as test objects. Tooth as an object has varied morphology and position in the oral cavity along with supporting structures, few commercially available thermoplastic polymer sheets that are utilized for aligner and retainer fabrication were thermoformed.
Ahn H et al[3] in their study implied the same regarding mechanical properties of the thermoplastic polymers when used clinically are different from those offered by the manufacturers because they are influenced by numerous environmental factors. The most significant drawback of the thermoformed retainers in daily usage is their low level of resistance to wear and fracture. Furthermore, their mechanical characteristics are significantly impacted by thermoforming processes.
In order to eliminate that, in the present study we had taken dental models as objects onto which the sheets were thermoformed to test their performance. The present study evaluated the tensile strength of some commercially used thermoplastic polymer sheets utilized for aligner fabrication. The thermoplastic polymer sheets showed variation when they were thermoformed and tested in two different models (pre-treatment model with moderate crowding and post-treatment model with well aligned teeth) of the same patient. Previously many studies were conducted to assess the property of the aligner material.
Our work not only focuses on the aspect but also analyzes the change in mechanical properties specifically tensile strength for specimens where thermoforming was done in pre-treatment and post-treatment model of the same patient. It is plausible that some permanent distortion occurred during the fabrication process. Otherwise, it may be considered that permanent deformation was introduced when the thermoplastic appliance was thermoformed on the dental model. Kohda et al[10] in his study on assessing the effects of mechanical properties of thermoplastic polymers also concluded the same. The author recommended this as an area for further investigation for elucidating the changes that occur which has an indispensable role in determining the material for specific clinical purpose.
Thermoplastic materials are viscoelastic in nature, which means that the force produced by an intended movement diminishes as a function of time. The appliance may experience significant deformation while being fitted, but a clear orthodontic appliance responds elastically by returning to its original shape as the short-term loading force that induced during the deformation is neutralized.[4]
Polyester, polyurethane, and polypropylene are the predominant thermoplastic materials used to fabricate clear orthodontic appliances. Poly (ethylene terephthalate)-glycol (PET-G) is a non-crystallizing amorphous copolymer of polyethylene terephthalate. Imprelon (Scheu-Dent), Placa Crystal (BioART) are made from PET-G, whereas, AVAC R (Jaypee) made from medical grade polymer and EZ-VAC (3A Medes) made from poly-ethylene. Among the brands subjected for testing, in the pre-treatment maxillary model, Placa Crystal (BioART) has shown to have better properties when compared to the analogous brands. When the same brands were tested after thermoforming on post-treatment maxillary model of the same patient, EZ-VAC (3A Medes) showed to have better performance. This could be attributed to the thermoplastic polymers made from PET-G which showed higher tensile strength in the study. Nonetheless, in post-treatment models, polyethylene showed a better performance than PET-G. Zhang et al[4] in their study declared that PETG is a modified product of PET, which has good mechanical properties, formability, fatigue resistance, and dimensional stability. The dimensional changes may cause variation in the fit of the appliances fabricated from these thermoplastic materials, causing changes to orthodontic forces exerted by these appliances. Study done by Daniele V et al [23], Xiang B et al[24] showed that among the available materials, PET-G has shown to have superior performance. These study stands in accordance with our study results where PET-G showed superior performance. The test values results were also statistically significant (P < .05).
Due to the height variation added with altered morphology of the tooth, the thermoplastic material tends to be stretched on their sides. Owing to this, the materials along the occlusal and the incisal surfaces tends to be thicker. This creates variation in the force delivery and the mechanical properties of the material is also inadvertently affected. These materials when they are uniformly stretched, tend to have higher strength, thus showing good performance. In our study the tensile strength of the sheets when comparing between pre-treatment and post-treatment model, the materials thermoformed on post-treatment models showed exceptional performance though the mean difference weren’t statistically significant (P > .05).
The materials though appear as a single unit, the polymer chains are stretched when they are adapted to the surfaces. The outer layer of the polymer chains is stretched more when compared to the ones that are near the model. The polymer chains arrangement fashion in the sheet as received and after thermoforming is accountable for the dimensional stability and accuracy of its adaptation. They highly influence the strength of the polymer sheet because when the sheets are thermoformed, they are stretched. This stretch of the material leads to change in the polymer chain arrangement. The orientation of the chains in the thermoformed sheet is highly influenced by the morphology of the model onto which the sheet is thermoformed. The stretch in the sheets causes thinning of the materials especially in areas of long teeth. The well aligned post-treatment model provides a favorable environment and allows the polymer chains to arrange in uniform manner.
Kwon et al[25] assessed the force delivery properties of thermoplastic orthodontic materials and found that the forces delivered by thin materials were greater than those delivered by thick materials of the same brand. Ammann R et al [26] in their study also showed the same where the thickness is affected and this in turn affects its mechanical properties. The thickness on the occlusal surface is more than compared to the labial and lingual/palatal surface. This variation of thickness on occlusal surface is beneficial to counteract the occlusal wearing away.
The findings of a study by Tamburrino et al [1] suggests that this can be linked to a phenomenon called drawing, occurring for different polymers when pulled in tension (the condition of thermoforming: the polymer is heated and pulled in tension). In particular, the polymer chains slide over each other, unraveling, so that they become aligned with the direction of stretch because of which the drawn material is stronger and stiffer than before. Barone et al [2] in his study stated about the thickness which strongly varies along the surface of the teeth. Assessing the mechanical properties is of utmost importance to evaluate the effectiveness of the orthodontic treatment for better understanding of the force delivery process.
It has been demonstrated that the high temperature and pressure that are given to thermoplastic materials lead them to crystallize from an amorphous condition, with the regular polymer chains being closely arranged over a considerable distance. A binding force greater than that in the amorphous zone is produced as the secondary bonding force that binds the polymer chains together and builds up. Additionally, amorphous materials can transform into crystalline ones when the temperature drops, and the crystalline phase can impact a material's mechanical properties. After thermoforming, orthodontic aligners need to be carefully examined in order to describe their qualities for clinical usage. Application of large forces to teeth may result in apical root resorption. [5]
Though the effectiveness of transparent orthodontic aligner for orthodontic treatment has been widely reported.[5] Our finding suggest that the physical and mechanical properties of thermoplastic materials used for the fabrication of transparent orthodontic aligners should be evaluated after thermoforming in order to characterize their properties for clinical application. They must be carefully selected depending on the treatment required.
. This raises a major concern on the effectiveness and shelf life of the polymer sheets when used clinically. In spite of the manufacturer claims, majority of the materials tend to show an enormous difference in their effectiveness while using clinically though their properties might be superior when tested using standard recommended conditions.