Keywords
maxillofacial prosthesis - silicone - pigmentation - coloring agents - hardness tests
- color test
Introduction
Literature studies report that silicone elastomer is the most used option for maxillofacial
prostheses.[1]
[2]
[3]
[4]
[5] Factors such as high humidity and temperature variation can degrade a silicone.[1]
[5] Silicone prostheses can be in direct contact with human blood, saliva, sweat, water
and food, as in situations of tongue and oronasal prostheses.[1] Thus, clinically, these prostheses are subject to temperature variations (caused
by the patient's diet) and high humidity.
Maxillofacial prostheses usually need to be replaced within 1 year due to their color
fading.[1]
[2] Despite this, it is not uncommon to observe patients wearing their prostheses for
more than 1 year due to financial problems.
Other reasons to replace a silicone prosthesis include changes to its hardness and
dimensions. The hardness of a silicone determines its flexibility.[2] A silicone prosthesis that simulates the flexibility of human skin promotes aesthetic
and functional comfort to the patient.[2] The dimensional stability of the material of a prosthesis is important to maintain
its adaptation to the place for which it was manufactured.[1]
[6] In addition, if a silicone prosthesis undergoes a significant dimensional change,
it may lose its function and appearance.[1]
[6]
A silicone prosthesis can be intrinsically pigmented. Despite this, in many situations
it is important to use an extrinsic pigment to more accurately simulate the chromatic
characteristics of human skin.[2] Thus, studies evaluating the effect of extrinsic pigmentation on the mechanical
and physical properties of a silicone are important for literature.
A search was performed on PubMed using the keywords “pigment” and “extrinsic” and
“silicone.” Only one article was found evaluating the effect of extrinsic pigmentation
on the color and hardness of a silicone after accelerated aging.[2] Thus, the objective of the present study is to evaluate the effect of extrinsic
pigmentation on the dimensional stability, hardness, detail reproduction, and color
of a silicone after thermocycling.
Materials and Methods
Formation of Groups
Sixty samples of MDX4–4210 silicone (Dow Corning Corporation Medical Products, United
States) with intrinsic pink pigment (H-109-P, Factor II, United States) and intrinsic
opacifier (TiO) were fabricated.
Thirty samples were manufactured with dimensions of 30 mm(Ø) × 3 mm,[4] and another thirty were manufactured with dimensions of 22 mm (Ø) × 2 mm.[7] Thus, two groups were formed, and in each group there were 15 samples with dimensions
of 30 mm (Ø) × 3 mm and 15 samples with dimensions of 22 mm (Ø) × 2 mm:
-
Group 1: group with intrinsic pigmentation (H-109P, Factor II + TiO) and without extrinsic
pigmentation (control).
-
Group 2: group with intrinsic pigmentation (H-109P, Factor II + TiO) and extrinsic
pigmentation (Tan FE - 215, Factor II, United States).
Using samples with dimensions of 30 mm (Ø) × 3 mm, dimensional stability, Shore A
hardness, and detail reproduction tests were performed.[4] Samples with dimensions of 22 mm (Ø) × 2 mm were used for color evaluation.[7] Readings for these tests were taken before (initial) and after thermocycling (final).
Sample Production
The silicone, intrinsic pigment, and intrinsic opacifier were weighed on a precision
digital scale (BEL Analytical Equipment, Brazil). The intrinsic pigment and the opacifier
each corresponded to 0.2% of the weight of the silicone.[1]
[2] The silicone was manipulated at 23° ± 2°C with a relative humidity of 50% ± 10%.[1]
[2] The two parts of silicone, Part A (catalyst) and Part B (base), were mixed until
a homogeneous mass was obtained. Subsequently, intrinsic pigment and intrinsic opacifier
were added to the silicone. For these steps, a vacuum mixture was performed using
a mechanical spreader (Polidental, Brazil).
The pigmented silicone was inserted into two different metallic matrices, and a spatula
was used to flatten and standardize its thickness.[1] The metal matrices were closed and subjected to a pressure of 1 ton for 10 minutes
(Maxx II; Essence Dental VH, Brazil).[2] Samples remained confined in the matrices under a controlled temperature (29°C)
with the surfaces exposed for 72 hours to complete the polymerization of the material.[1]
The extrinsic pigment (Tan FE–215, Factor II) was diluted in 1,1,1-trichloroethane
(I-301 Extrinsic Tri-Fluid, Factor II, United States) in the proportion of 1 mL (extrinsic
pigment) to 1 mL (1,1,1-trichloroethane).[2] This extrinsic pigment diluted in 1,1,1-trichloroethane was uniformly blasted onto
the surface of the samples (Group 2) with the help of an airbrush (WIMPEL, Brazil).[2] Subsequently, the extrinsic paint was sealed following the manufacturer's recommendations.
The extrinsic pigment corresponded to 0.2% of the silicone weight.[2]
Dimensional Stability
A three-dimensional optical microscope (Quick Scope, Mitutoyo, United States) was
used to calculate the dimensions of the samples.[8] This microscope had a digital table with a magnification of 350x and an accuracy
of 1 μm.[8] Measurements were calculated using QSPAK software (Mitutoyo, United States).[8]
Hardness
The evaluation of the Shore A hardness test was performed with a digital durometer
(GSD 709 Teclock, Japan) according to the American Society for Testing and Materials
(Designation D2240).[2] The needle penetrated the samples at a load of 10 N.[2] The measurement was established between 0 and 100 Shore A with 1% of tolerance,
and therefore hardness values were expressed in Shore A units.[2] Each sample was placed on the durometer table at a distance of ± 2 mm from the
penetration tip of the device.[2] The penetration tip applied pressure for 15 seconds on the samples.[2] Three measurements were performed on each sample, and later, an average of the three
measurements was obtained.[2]
Detail Reproduction
In the detail reproduction test, the angular accuracy of three grooves (20 μm, 50
μm and 75 μm wide) molded in each sample was recorded.[4] Detail reproduction was examined using a stereo microscope (Olympus, Japan) under
low-angle illumination at 13× magnification.[4] To classify the accuracy of detail reproduction, the scores suggested by Goiato
et al were used as described below: X: no groove reproduction; 0: full reproduction
of two of the three grooves; 1: full reproduction of the three grooves, with inaccurate
angles; and 2: full reproduction of the three grooves, with accurate angles.[4]
Color Change
The color readings were taken using a spectrophotometer of visible ultraviolet reflection
(UV-2450, Shimadzu, Japan).[2] Color alteration (ΔE) was calculated by the Commission Internationale de L'Eclairage (CIE) L*a*b* system.[2] The following formula was used: ΔE = [(ΔL)2 + (Δa)2 + (Δb)2]½.[2] The “L” represents brightness from 0 (black) to 100 (perfect white), the “a” represents the amount of red (positive values) or green (negative values), and the
“b” represents the amount of yellow (positive values) or blue (negative values).[2]
Thermocycling
The samples were subjected to 2,000 immersion cycles in alternating 60-second baths
of distilled water at 5 ± 1°C and 55 ± 1°C (MSCT-3, Convel, Brazil).[9]
[10]
Statistical Analysis
Statistical evaluations were performed using the Jamovi software (Version 2.2.5.0,
Jamovi Project, Australia).
The interaction of pigment (presence or absence of extrinsic pigment) with dimensional
stability or hardness was verified by two-way analysis of variance (ANOVA).
One-way ANOVA was used for the color test. In the case of statistical difference,
the HSD Tukey test was applied.
In all cases, values were considered significant when p was less than 0.05.
All samples achieved the same detail reproduction score, so no statistical evaluation
was performed.
Results
For the dimensional stability test, there was a significant difference between time
points (initial × final) for the groups with and without extrinsic pigmentation (p <0.05) ([Table 1]). Therefore, there was a significant contraction of samples from these groups after
thermocycling.
Table 1
Mean results (%) of the dimensional stability test
|
Groups
|
Time points
|
|
Initial
|
Final
|
|
Group 1 (No extrinsic pigment)
|
0.89 Aa
|
1.26 Ab
|
|
Group 2 (With extrinsic pigment)
|
0.98 Aa
|
1.42 Ab
|
Note: (Tukey p <0.05) Different lowercase letters horizontally show statistical significance. Different
uppercase letters vertically show statistical significance.
For the hardness test, only the group without extrinsic pigmentation showed a significant
difference between time points (p <0.05). Thus, there was a significant reduction in the Shore A hardness of this group
after thermocycling (p <0.05). Comparing group 1 with group 2 at the initial time point, the group without
extrinsic pigmentation showed significantly greater Shore A hardness (p <0.05) ([Table 2]).
Table 2
Mean results of the Shore A hardness test
|
Groups
|
Time points
|
|
Initial
|
Final
|
|
Group 1 (no extrinsic pigment)
|
25.5 Aa
|
21.2 Ab
|
|
Group 2 (with extrinsic pigment)
|
21.4 Ba
|
22.7 Aa
|
Note: (Tukey p <0.05) Different lowercase letters horizontally show statistical significance. Different
uppercase letters vertically show statistical significance.
Groups 1 and 2 scored 2 for the detail reproduction test, before and after thermocycling.
For the color test, comparing the group with extrinsic pigmentation (ΔE = 1.95) with
the group without extrinsic pigmentation (ΔE = 1.70), there was no statistically significant
difference (p = 0.431).
Discussion
Intrinsic and extrinsic factors can cause polymer degradation (e.g., silicone elastomer).[1]
[2]
[3]
[4]
[5]
[7] The intrinsic factor is related to changes in the silicone matrix, causing its degradation.[2] The extrinsic factors such as ultraviolet radiation, daily handling, temperature,
air pollution, and high humidity can also cause degradation of this material.[2]
[5] In this study, thermocycling was used to simulate extreme conditions of high humidity
as well as temperature changes (extrinsic factors) in the patient's mouth over a period
of time. The literature reports that 2,000 thermal cycles clinically represent 2 years
of wearing a complete denture,[9]
[10]
[11] so this could also represent 2 years of wearing a silicone prosthesis.
For the dimensional stability test, there was a significant contraction of samples
in both groups after thermocycling, and this represents a degradation of the material
([Table 1]). The highest contraction value observed in this study was 1.42% (Group 2). Despite
this, the average dimensional change in the two groups, before and after thermocycling,
remained within the standard recommended by ISO 4823, which states that the contraction
should not exceed 1.5% after 24 hours (clinically acceptable).[4]
For the extrinsic pigmentation group, there was no significant change in the Shore
A hardness value after thermocycling ([Table 2]). Probably, the extrinsic pigment acted as a protective factor for the hardness
of the MDX4–4210 silicone during thermocycling, preventing the degradation of this
physical property. It is possible to reach this conclusion because the group without
extrinsic pigmentation showed a reduction in the hardness of the samples after thermocycling
([Table 2]). Despite this, further studies are needed to confirm this result.
The ideal Shore A hardness should be 25 to 35 units or 25 to 55 units.[12] Despite this, it is possible to observe articles in the literature that found Shore
A hardness values lower than 25 units for silicones after their production.[13]
[14]
[15] In addition, Goiato et al considered clinically acceptable the Shore A hardness
of 18.08 units of a silicone.[14] Thus, based on this information, it is possible to consider all hardness values
obtained in this study clinically acceptable ([Table 2]).
Regarding the detail reproduction test, all groups scored 2. This score indicates
that all samples had a full reproduction of the three grooves with accurate angles.
This result is in agreement with Goiato et al, who reported that silicones have an
excellent ability to reproduce details, reproducing grooves of up to 20μm wide.[16]
Based on clinical acceptability threshold, ΔE <3.3 represents a clinically acceptable color change for a material, and ΔE ≥3.3 represents a clinically unacceptable color change for a material.[17]
[18]
[19] In the present study, the color changes observed in the evaluated groups were less
than 3.3, and therefore, clinically acceptable.
In this study, an intrinsic opacifier (TiO) was used in all samples. This was done
to simulate a clinical situation, as the opacifier prevents the silicone prosthesis
from becoming translucent. In addition, this component has the function of protecting
the silicone prosthesis from the chromatic changes caused by ultraviolet radiation.[20] TiO is used in the manufacture of sunscreens to protect human skin against ultraviolet
rays, as it has a high refractive index.[21]
Based on this study, the extrinsic pigment can be indicated for the manufacture of
maxillofacial prostheses, as it does not cause disadvantages to silicone over time.
It is also important to remember that the association between extrinsic and intrinsic
pigmentation can more accurately mimic the chromatic characteristics of human skin.
Despite the important results of the present study, more studies of this nature are
needed.
Conclusion
Based on the tests performed, extrinsic pigmentation did not show a negative effect
on silicone, and therefore it can be indicated. The results of the dimensional, hardness,
detail reproduction and color evaluations of the MDX4–4210 silicone were clinically
acceptable in all cases in the groups with and without extrinsic pigmentation.
