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m m d d y y / 14
ANAPLASTOLOGIST / DENTALLABORATORYTECHNICIANQUESTIONNAIRE
Version 2.8
Multicenter Trial of CPE for MaxillofacialProsthetics
Date___/____/____ Time at Completion__:__ (24 hour clock)
Anaplastologist or Dental Laboratory Technician______
Prosthesis 1 Re-fabrication
Facial Prosthesis Type:
___Partial Nasal ____Full Nasal ____Partial Ear __ Full Ear __ Partial Orbital __ Full Orbital ___Partial Facial ____ Full Facial ____Other______
Maxillofacial prosthetic material:
Silastic ______
Batch Numbers: 80% by volume Medical Adhesive Type A
20% by volume Silastic MDX4-4210, base
Chlorinated polyethylene ______Base shade in Munsell coordinates
Varnish Type: Type 1 Type 2 Type 2C Type 2D
DIRECTIONS: Please rate the following qualities on a scale from zero to 10.
1.GeneralFeatures:
1.1 How easy was it to manipulate the maxillofacial material in the flask?
0 1 2 3 4 5 6 7 8 9 10
very very
easy difficult
1.2 Estimate the degree of complexity of this prosthesis shape and its mold cavity?
0 1 2 3 4 5 6 7 8 9 10
very very
easy difficult
1.3 How many pieces of the mold are required? (Count the lower and upper halves of the mold and all acrylic projections, pedestals, or other component as a “piece.”) ______
1.4 How many prostheses were fabricated before a satisfactory one was produced? ______
Why? ______
1.5 How much time was required for: Technical (Bench) Time (in minutes)
(± 15 minutes, from Step Charts) Processing Time
Clinical (Coloring) Time
Total Time
1.6 Where there any physical flaws/ breaks encountered during processing or finishing of material (mold or prosthesis)? (yes or no)
If yes,
Describe Flaw No. 1______
0 1 2 3 4 5 6 7 8 9 10
no need to not
correct correctable
Describe Flaw No. 2______
0 1 2 3 4 5 6 7 8 9 10
no need to not
correct correctable
Describe Flaw No. 3______
0 1 2 3 4 5 6 7 8 9 10
no need to not
correct correctable
1.7 How easy was it to produce a featheredge?
0 1 2 3 4 5 6 7 8 9 10
very very
easy difficult
2.0 Specific Attributes
2.1 How many trial packs were required?
If silicone and more than one pack, why? ______
2.2 When silicone was removed from the mold, did the urethane lining separate? Y or N
2.3 Draw the periphery of the finished prosthesis on the master cast. (Measure the length in mm)
2.4 How resistant was the prosthesis to tearing or gouging during recovery, finishing or polishing?
A. Material could not be torn or gouged
B. Tears or gouges occurred only when prosthesis was abused
C. Moderate care was required to avoid flaws,
D. Defects were easy to produce
E. Not resistant at all, requires extreme care to prevent damage
F. Prosthesis was destroyed
3. COLORING AGENTS:
3.1 Indicate pigments used for internal coloring of the silicone prosthesis. (Grumbacher Artist’s Oil Colors)
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
_____Cadmium-Barium Red Deep
_____Cadmium-Barium Red Medium
_____Yellow Ochre
_____Raw Umber
_____Raw Sienna
_____Paynes Gray
_____Burnt Sienna
_____Thio Violet
_____Titanium White
_____Other______
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
Opacity Agent
_____ Georgia Kaolin
3.2 Indicate FACTOR II fibers used for internal coloring.
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
_____Bright Red
_____Dark Red
_____Pink
_____Pink Violet
_____Violet
_____Dark Brown
_____Light Brown
_____Light Buff
_____Black
_____White
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
NOTE: Save a swatch of each material used for each patient for use in the clinical evaluation. Place each piece of material in a separate plastic bag to keep it from contamination. Label with the all patient data.
EXTERNAL COLORING:
3.4 Indicate pigments used for external coloring of the prosthesis. (Grumbacher Artist’s Oil Colors)
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
_____Cadmium-Barium Red Deep
_____Cadmium-Barium Red Medium
_____Yellow Ochre
_____Raw Umber
_____Raw Sienna
_____Paynes Gray
_____Burnt Sienna
_____Thio Violet
_____Titanium White
_____Other______
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
3.5 Indicate FACTOR II fibers used for external coloring.
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
_____Bright Red
_____Dark Red
_____Pink
_____Pink Violet
_____Violet
_____Dark Brown
_____Light Brown
_____Light Buff
_____Black
_____White
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
3.6 How much difficulty was involved in the external coloring of the prosthesis?
0 1 2 3 4 5 6 7 8 9 10
very very
easy difficult
3.7. Provide other comments regarding the flasking, packing, molding, laminating and finishing of the prosthesis.______
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
4. Photographs
(TURN OFF THE ROOM LIGHTS AND PULL DOWN THE WINDOW SHADES)
Initials of the evaluator or recorder using the camera: ______
Take photos under this light source of the Macbeth Examolite (D65 Daylight):
Tissue side (showing all or most of the margins): Non-tissue side:
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics
Subject No. / Site Code / Visit / Visit Date / CRF Page__ __-______-__ __ / __ __ / 2 / __ __/__ __/__ __
m m d d y y / 14
Make 3 color prints of the finished prosthesis on the cradle for use in the OCQ and ICQ (question 1)
PHOTOS OF OTHER AREAS OF INTEREST (Do not hesitate to make more photographs of details ad libitum.)
Failure (only to be completed if the prosthesis fails) Failure ______Date
5. Place the prosthesis on the original cast or storage cradle. If the prosthesis cannot be placed on the cast, use comparative measurements of the cast and the prosthesis to determine how much of the original material is gone. Draw the periphery again of the finished prosthesis on the master cast. (Measure the length in mm)
5.1 How many mm of the original perimeter are missing?
5.2 What percentage of the original perimeter is missing?
6. What is the number of discrete tears?
6.1 What is the length, width and depth in mm
(thickness) of the largest tear?
6.2 What is the length, width and depth in mm
(thickness) of the average tear?
7. Please draw or make a digital photograph of the prosthesis indicating margin loss, major tears, or other flaws. Include important measurements in the sketch, i.e., length of tears, width of margin loss, etc.).
8. What are the major reasons for considering this prosthesis a failure?
Primary______
Secondary______
University of Louisville Multicenter Trial of CPE for Maxillofacial Prosthetics