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

J Prosthet Dent. 2004 Sep;92(3):294-8. doi: 10.1016/j.prosdent.2004.06.007.

Abstract

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 specified 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. Secure 2 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 (alpha=.05).

Results: Tests of left-right differences were insignificant ( 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 significantly 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 difficult-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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adhesives / chemistry*
  • Bandages
  • Biocompatible Materials / chemistry
  • Dimethylpolysiloxanes / chemistry
  • Humans
  • Matched-Pair Analysis
  • Maxillofacial Prosthesis*
  • Pilot Projects
  • Polyurethanes / chemistry
  • Prosthesis Fitting*
  • Random Allocation
  • Silicone Elastomers / chemistry*
  • Silicones / chemistry
  • Skin
  • Statistics, Nonparametric
  • Stress, Mechanical
  • Time Factors

Substances

  • Adhesives
  • Biocompatible Materials
  • Dimethylpolysiloxanes
  • MDX 4-4210
  • Polyurethanes
  • Silicone Elastomers
  • Silicones
  • baysilon
  • epithane-3