Effect of multi-adhesive layering on retention of extraoral maxillofacial silicone prostheses in vivo

Sudarat Kiat-amnuay, DDS, MS,a Lawrence Gettleman, DMD, MSD,b and L. Jane Goldsmith, PhDc Dental Branch, University of Texas Health Science Center, Houston, Texas; School of Dentistry and School of Public Health and Information Sciences, University of Louisville, Louisville, Ky Statement of problem. Loss of retention of maxillofacial prostheses often makes the margin visible or the
prosthesis dislodge. Using several medical adhesives in combination may improve retention.

Purpose. The purpose of this study was to investigate the effect of single- and multi-adhesive layering of 2
adhesives on the retention of maxillofacial silicone elastomer strips adhered to the skin of human forearms using a peel test. Material and methods. Power analysis from a previous study and a pilot trial specied at least 20 subjects. Eight Silastic Adhesive A/MDX4-4210 silicone rubber strips (N=240) were applied in a predetermined random order to the left and right ventral forearms of 30 IRB-approved human subjects. Skin-Prep Protective Dressing was applied. Secure2 Medical Adhesive (SMA) and Epithane-3 (E3) adhesive were used alone or as SMA/E3 or E3/SMA sandwiches (from skin to prosthesis) to adhere strips. Strips were peeled 6 hours later in a universal testing machine at 10 cm/min and data reported in N/m. Paired t tests were used to evaluate left and right arm differences. A Friedman test for nonparametric correlated data with within-subject design was performed, determining differences between both adhesives singly and in combination (a=.05). Results. Tests of left-right differences were insignicant (P=0.43), so the data from both arms were combined. Many strips with E3 did not adhere before testing and were counted as 0 adhesion. Median peel strengths (and 25th and 75th percentiles) in N/m were: SMA = 76.1 (47.1-107), E3 = 6.75 (0.0-25.9), SMA/E3 = 107 (78.0-132), and E3/SMA= 19.6 (6.99-42.4). All 4 variables were signicantly different (P,.0005). Conclusion. The multi-adhesive combination of SMA/E3 had the highest adhesion, followed, in order, by SMA alone, E3/ SMA, and E3 alone. Both E3 groups left a difcult-to-remove residue on the skin. SMA/E3 left a halo-like residue on the skin at the periphery of the strips from the E3 leaking around the SMA. SMA remained adherent to the prosthetic material. (J Prosthet Dent 2004;92:294-8.)

CLINICAL IMPLICATIONS
The results of this study indicate that, after applying Skin-Prep Protective Dressing, skin adhesion improves when combining adhesives: Secure2 Medical Adhesive (SMA) to the skin and Epithane-3 (E3) to the silicone prosthesis. Adhesion was higher with this combination than when using either adhesive alone, or with the opposite combination (SMA against the silicone prosthesis and E3 against the skin).

Presented at the International Association for Dental Research meeting, Goteborg, Sweden, June 29, 2003. Supported by Intramural Research Incentive Grant-Project Completion Grant (No. 628703) from the Vice President for Research, University of Louisville. a Assistant Professor, Department of Restorative Dentistry and Biomaterials, University of Texas Health Science Center at Houston, Dental Branch at Houston; Adjunct Assistant Instructor, Department of Diagnostic Sciences, Prosthodontics, and Restorative Dentistry, University of Louisville School of Dentistry. b Professor, Department of Diagnostic Sciences, Prosthodontics, and Restorative Dentistry, University of Louisville School of Dentistry. c Associate Professor, Department of Bioinformatics and Biostatistics, University of Louisville School of Public Health and Information Sciences.

he success of most nonimplant-retained or nonmagnet-retained maxillofacial prostheses depends on retention derived from medical skin adhesives.1 Lack of retention of maxillofacial prostheses often makes the margin visible or the prosthesis dislodge. Only a few studies have tested the bond strength of maxillofacial prostheses.2-5 Wolfaardt et al2 performed a pilot study on 2 human subjects using 3 skin adhesives with a special apparatus. Polyzois et al3 used 5 silicone elastomers to test the direct tensile bond strength of 4 skin adhesives and of 5 double-sided adhesive tapes.4 Failure of skin prostheses, however, is better characterized as a debonding or peel phenomenon.5
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The results from the authors previous studies6,7 showed that a skin dressing, Skin-Prep Protective Dressing, applied to the skin of 20 human subjects before adhering a maxillofacial prosthesis, improved bond strength of both a silicone-based adhesive, Secure2 Medical Adhesive (SMA), and a water-based adhesive, Epithane-3 (E3). SMA was 3 to 5 times more retentive than E3, adhered to the silicone strip, and left no residue on the skin. E3 separated from the silicone strip and left a very difcult-to-remove residue on the skin. Furthermore, the application of a second coat of SMA after a 4-hour interval enhanced the adhesion of the prosthesis. It was thought that combinations of the adhesives may have a greater afnity to either the skin or the prosthesis alone, and might improve prosthesis retention. The purpose of this study was to investigate the effect of single- and multi-adhesive layering of SMA and E3 on the retention of maxillofacial silicone elastomer strips adhered to the skin of the forearms of 30 human subjects by using a peel test. The research hypothesis was that a peel test of silicone maxillofacial elastomer strips attached to human forearms, using a combination of 2 adhesives in 2 layers, would show no differences in retention compared to using either adhesive in a single layer.

Table I. Materials used in this study

Product Manufacturer Batch number

Silastic MDX4-4210 Part A only Silastic Medical Adhesive Type A Secure2 Medical Adhesive Epithane-3 Adhesive ES Skin-Prep Protective Dressing Dial Soap

Dow Corning, Midland, Mich Dow Corning, Midland, Mich Factor II, Lakeside, Ariz Daro Products, Muskego, Wis Smith 1 Nephew, Largo, Fla Dial., Scottsdale, Ariz

GG872706 0000731953 R834589-2 11201 480919 017000011912

MATERIAL AND METHODS

Silicone rubber strips (60 3 20 3 3 mm) were processed into 2-part 6-sided gypsum molds using a mixture of room temperaturevulcanizing silicone elastomer (40% vinyl-terminated dimethylsiloxane (MDX4-4210) and 60% dimethylsiloxane triacetoxy terminated silane (Silastic Adhesive Type A), both from Dow Corning.6-9 The elastomer mixture was allowed to polymerize for 24 hours. The materials used in this study are shown in Table I. Sample size was determined by power analysis10 from the variation in the population used in a previous study6 and from a pilot trial of multiple adhesive applications on 2 human subjects. The analysis indicated that at least 20 subjects using 4 specimens on each forearm would be sufcient. University Human Studies Committee approval was received, and 30 human subjects varying in race, gender, and age were recruited at the University of Louisvilles Health Sciences Center. At the rst visit, subjects signed a consent form, and were given a bar of soap (Dial deodorant soap) for use during bathing or showering the night before or the morning of the trial, to help standardize the soap lm and skin condition. Clear acetate stencils were used to dene all 8 sites on the volar skin surface of each subjects right and left forearms. All 8 variables were assigned in a nonsequential random pattern among the 4 sites located between the wrist and elbow of each
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arm, angled in an inferiolateral to superiomedial direction (toward the subjects head). Landmark points for each subject were drawn on the stencil and on the skin for subsequent repositioning. SP was applied to all 8 sites and allowed to air dry for a few minutes. Then SMA alone, E3 alone, SMA/E3 or E3/SMA sandwiches (from skin to prosthesis) were applied to the skin and silicone rubber strips following a random schedule, and adhered immediately to the skin through the mask on both arms. The subjects were asked to cover their arms with long sleeves for the rest of the day and dismissed. Subjects returned 6 hours later as in the earlier study.6 All strips were peeled in a universal testing machine (Instron model TM-M; Instron Corp, Canton, Mass), equipped with a CM load cell, at 10 cm/min. Peeling was in the inferiolateral-to-superiomedial direction to establish a 90-degree peel test.6,7,11 The load cell recorded the maximum force necessary to remove the strip as a function of distance peeled. Calibration and measurements were made in grams-force to 3-digit accuracy. The retention measurement was then converted to newtons and the results were reported in newtons/ meter (N/m), where m is the width of the silicone rubber strip in meters. Statistical analysis evaluated left-right arm differences using a paired t test. Due to the observed data characteristics from some silicone strips that did not adhere during the trial, a Friedman test for nonparametric correlated data with within-subject design was performed, determining differences between both adhesives singly and in combination at the 0.05 signicance level. All statistical analyses were done using statistical software (SPSS software, Version 11; SPSS, Chicago, Ill).

RESULTS
The median peel strengths and 25th and 75th percentiles of bond strengths measured from all 8 strips on both arms of all 30 subjects, reported in N/m
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Fig. 1. Adhesion of maxillofacial prosthetic silicone rubber strips to skin of 30 human subjects using Secure2 Medical Adhesive (SMA) and Epithane-3 (E3) alone and as sandwiches of 2 adhesives. Circle, Outlier values; box, interquartile range; midline, median.

(25th and 75th percentile) were: SMA: 76.1 (47.1107), E3: 6.75 (0.0-25.9), SMA/E3: 107 (78.0-132), and E3/SMA: 19.6 (6.99-42.4). In Figure 1, the boxes indicate the interquartile range (50% of the data) except for 3 outliers shown as circles. Left-right differences were insignicant (P=0.43), so the data from both arms were combined. Of the 60 strips for each group (240 total for all groups), 29 strips of the E3, 23 strips of the E3/SMA, and 1 strip each of the SMA and the SMA/E3 groups did not adhere before testing and were counted as 0 adhesion. The rst and second strips, placed closer to the wrist on both forearms, fell off the most (16 strips each), followed by the strips closest to the elbow (15 strips), with the least at the position third closest to the wrist (12 strips). Differences among the 4 adhesive methods were significant (P,.0005), with SMA as the stronger adhesive. SMA remained adhered to the prosthesis most of the time. E3 and E3/SMA (skin/prosthesis) left a difcult-to-remove gummy residue on the skin and the prosthetic material. SMA/E3 (skin/prosthesis) left a skin residue at the periphery of the affected area.

DISCUSSION
A peel test of silicone maxillofacial elastomer strips attached to human forearms, using a combination of 2 adhesives in 2 layers, showed differences in retention, compared to using either adhesive in a single layer. The research hypothesis was therefore rejected. This human in vivo study was limited to active working students, staff, and faculty of the University of
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Louisvilles School of Dentistry. It was performed in the winter when many study participants were wearing long-sleeved garments or clinic gowns, so friction may have affected the rate of failures seen. The previous study6 was conducted in early summer where longsleeved garments may have caused more perspiration than in the winter; fewer specimens fell off in summer, however. The relative skin bond strengths of SMA and E3 to the silicone materials were similar but lower than the previous study,6 where the mean and the present studys median peel strengths were, respectively, 111 and 76.1 N/m for SMA and 27.0 and 6.75 N/m for E3. The subjects participating in this study, however, were not the same and the materials used had different batch numbers, which may have affected the results. In the present study, the combination of SMA/E3 (skin/prosthesis) demonstrated the highest bond strength, followed by SMA alone, E3/SMA (skin/prosthesis), and then E3. Although E3 adhesive was much less retentive when applied next to the skin, compared to SMA, the double application method resulted in a tripling of the skin bond strength. SMA was much more retentive than E3 when applied to the skin. Combining them in a sandwich with SMA against the skin and E3 against the prosthetic material, bond strength increased by approximately one third over that of SMA alone. Although specimens in 43% of subjects (13 out of 30) with E3 and E3/SMA did not adhere for the full 6 hours under long-sleeved garments (counted as 0 retention), the nonparametric analysis was signicant. The power analysis done in advance assumed a normal distribution and, when using 0.5 as a correlation estimate, 20 subjects were found to yield 85% power. Thirty subjects
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were chosen because they were predicted to yield 96% power. Upon completion of the study, the distribution of the data did not meet the normality requirement of the power analysis. The sample size that was used was adequate, however, to attain statistical signicance using the nonparametric Friedman test. Although E3 is a water-based adhesive, when used alone or in the E3/SMA sandwich, it left a difcult-toremove gummy residue on the skin and the prosthesis. Some subjects reported that it took more than a week before the entire residue rubbed off after this single application of adhesive. In contrast, SMA, a silicone-based adhesive, left a peelable layer which adhered to the silicone prosthesis only. The SMA/E3 group failed at the SMA-skin interface, showing that the sandwich of the 2 adhesives permitted the E3 to adhere better to the silicone rubber than when used by itself. Removal of this adhesive using the Secure2 adhesive remover was not evaluated. From the results of the present study, a better conguration of these 2 adhesives to obtain the highest skin bond strength would be to apply E3 to the silicone prosthesis just short of the margin to prevent it from leaking onto the skin. SMA would then be applied all the way to the margin. This technique would maximize the retentive effects of both skin adhesives. The choice of adhesive, however, would still depend on clinical judgment for each patient. There are many studies2-5,12,13 which tested the skin adhesion of extraoral maxillofacial prostheses. Due to the different choices in materials (silicones and adhesives) and the mechanical methods used (tensile, torsion, tensile-torsion, shear, strip, and peel), the results of these studies are not directly comparable to methods used here. Standardized peel tests for elastomers have not been developed for feather edges encountered in facial prostheses, so ASTM14 methods for specimens of even thickness were adapted in this and in the previous studies.6,7,11 Tam et al13 in 1992 developed an apparatus that simultaneously applied shear and tensile forces, but on only 2 pilot patients.2 This method has not been adopted by other investigators as yet. An appropriate test for facial prosthesis adherence would require that the substrate (skin) moves, while the adherend (prosthesis) does not. This could be the subject of future research. The silicone rubber formula used in this study has been widely used by many centers for decades, developed by Udagama.15 In the United States, there are 2 methods for making silicone facial prostheses, 1 with a urethane lining under the silicone prosthesis and 1 without. The previous studies6,7 focused on the silicone prosthesis without the urethane liner. Such prostheses build up layers of adhesive on the skin surface, leading to tearing of the fragile silicone margins during removal of the adhesive. The SMA layer against the skin and the
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E3 layer against the prosthesis might be optimal for skin adhesion and for strippability from the prosthesis because E3 adheres less well to the silicone than SMA. Future research on the effect of adhesives on urethanelined maxillofacial prostheses, on other formulations of silicone rubber, and other maxillofacial prosthetic materials is needed.

CONCLUSIONS
In this in vivo study, signicant differences between the 2 adhesives and 4 application methods were found. Multi-adhesive SMA/E3 (skin/prosthesis) displayed signicantly higher skin bond strength than SMA alone (107 versus 76.1 N/m, a 1.4-fold difference), E3/SMA (skin/prosthesis) (19.6 N/m) and E3 (6.75 N/m); both E3 groups left a very difcult-to-remove residue on the skin. SMA/E3 left a residue on the skin at the periphery. SMA remained attached to the prosthesis. A sandwich of E3 against the silicone prosthesis and SMA against the skin yielded the highest skin adhesion.
The authors wish to thank Dr James P. Scheetz for his assistance. Factor II and Smith 1 Nephew provided some materials for this study.

REFERENCES
1. Chalian VA, Bogan RL, Sandlewick JW. Retention of prostheses. In: Chalian VA, Drane JB, Standish SM, editors. Maxillofacial prosthetics: multidisciplinary practice. Baltimore: Williams & Wilkins; 1971. p. 131. 2. Wolfaardt JF, Tam V, Faulkner MG, Prasad N. Mechanical behavior of three maxillofacial prosthetic adhesive systems: a pilot project. J Prosthet Dent 1992;68:943-9. 3. Polyzois GL, Oilo G, Dahl JE. Tensile bond strength of maxillofacial adhesives. J Prosthet Dent 1993;69:374-7. 4. Polyzois GL. Bond strength of double-sided adhesive tapes used for facial prostheses. Spec Care Dentist 1994;14:26-9. 5. Haug SP, Richard GE, Margiotti E, Winkler MM, Moore DJ. An in vivo evaluation of adhesives used in extraoral maxillofacial prostheses. J Prosthodont 1995;4:11-5. 6. Kiat-amnuay S, Gettleman L, Khan Z, Goldsmith LJ. Effect of adhesive retention on maxillofacial prostheses. Part 1. Skin dressings and solvent removers. J Prosthet Dent 2000;84:335-40. 7. Kiat-amnuay S, Gettleman L, Khan Z, Goldsmith LJ. Effect of adhesive retention on maxillofacial prostheses. Part 2. Time and reapplication effects. J Prosthet Dent 2001;85:438-41. 8. Udagama A. Dental oncology and maxillofacial rehabilitation. In: Gunn AE, editor. Cancer rehabilitation. New York: Raven; 1984. p. 47-92. 9. Farah JW, Robinson JC, Hood JA, Koran A, Craig RG. Force-displacement properties of a modied cross-linked silicone compared with facial tissues. J Oral Rehabil 1988;15:277-83. 10. Muller KE, LaVange LM, Ramey SL, Ramey CT. Power calculations for general linear multivariate models including repeated measures applications. J Am Stat Assoc 1992;87:1209-26. 11. Gettleman L, Ross-Bertrand L, Gebert PH, Guerra LR. Novel elastomers for denture and maxillofacial prosthetics. In: Sauer B, editor. Biomedical engineering IV, recent developments: proceedings of the fourth Southern Biomedical Engineering Conference, Jackson, Miss, USA, October 11-12, 1985. New York: Pergamon; 1985. p. 141-4. 12. Andrews EH, Khan TA, Majid HA. Adhesion to skin. Part I: Peel tests with hard and soft machines. J Mater Sci 1985;20:3621-30. 13. Tam V, Faulkner MG, Wolfaardt JF. Apparatus for the mechanical testing of maxillofacial prosthetic adhesives. J Prosthet Dent 1992;67:230-5. 14. ASTM Standard D1876-01, Standard Test Method for Peel Resistance of Adhesives (T-Peel Test). In: ASTM Book of Standards. 003. Conshohocken, PA: ASTM International; p. 15.06.

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15. Udagama A. Urethane-lined silicone facial prostheses. J Prosthet Dent 1987;58:351-4. Reprint requests to: DR SUDARAT KIAT-AMNUAY 6516 M. D. ANDERSON BLVD. SUITE #493 HOUSTON, TX 77030 FAX: 713-500-4108 E-MAIL: sudarat.kiat-amnuay@uth.tmc.edu

0022-3913/$30.00 Copyright 2004 by The Editorial Council of The Journal of Prosthetic Dentistry

doi:10.1016/j.prosdent.2004.06.007

Noteworthy Abstracts of the Current Literature

Randomized controlled clinical trial on satisfaction with resilient denture liners among edentulous patients Kimoto S, Kitamura M, Kodaira M, Yamamoto S, Ohno Y, Kawai Y, Kawara M, Kobayashi K. Int J Prosthodont 2004;17:236-40.

Purpose. The purpose of this study was to measure patients satisfaction and their preference between mandibular dentures with permanent silicone-based resilient denture liner (SR) and conventional heatactivated acrylic resin (AR), both opposed by acrylic resin-based maxillary complete dentures. Materials and Methods. Twenty-eight edentulous patients who had fullled selection criteria and provided informed consent were enrolled in this trial. Subjects were allocated randomly to either arm of cross-over groups (AR-SR/SR-AR), stratied by gender, using a random permuted block within the strata method. The AR-SR group received AR denture treatment followed by SR denture treatment. The SR-AR group received treatment in the reverse sequence. The primary outcome was patient satisfaction measured on 100-mm VAS, analyzed by two-way ANOVA and the Bonferroni multiple comparison as a post hoc test. The secondary outcome was patients preference, evaluated by chi-square goodness-of-t test. An intention-to-treat analysis was performed. Results. Twenty-ve subjects were enrolled in the analysis. There were no signicant differences between AR and SR dentures 1, 2, and 3 months after the completion of control. Eighteen of 25 patients preferred SR dentures. Conclusion. Although there were no signicant differences in patient satisfaction ratings between the two types of dentures, a signicant majority of patients preferred those with a resilient denture liner.Reprinted with permission of Quintessence Publishing.

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