Clinical performance and periodontal outcome of temporary crowns and

fixed partial dentures: A randomized clinical trial

Ralph Gunnar Luthardt, Dr med dent,a Mandy Stößel, Dr med dent,b Monika Hinz, Dr med dent,c
and Rüdiger Vollandt, Dr rer natd
Technical University Dresden, Medical Faculty Carl Gustav Carus, Dresden, and Friedrich-Schiller-
University, Jena, Germany
Statement of problem. Different materials (autopolymerizing, dual curing, and light initiated) are used
for fabricating provisional restorations during prosthetic treatment. Randomized clinical trials that have eval-
uated these provisional materials have not been published.
Purpose. This clinical trial compared the handling, fitting, plaque adherence, gingivitis, color stability, and
the subjective assessment of the provisional materials by the patient and the dentist for 2 autopolymerizing
(Protemp, Luxatemp), 1 dual-curing (Provipont), and 1 light-initiated (Triad-VLC) material for the manu-
facturing of temporary crowns and fixed partial dentures.
Material and methods. Thirty subjects in need of 2 similar fixed prosthetic restorations (single crowns
[20], three-quarter crowns [2], connected crowns [9], or fixed partial dentures [30]) were treated with 1
temporary restoration of Protemp II (control) and one randomly selected from Luxatemp, Provipont, or
Triad-VLC materials. The mean time of treatment was 37.5 days (minimum 2 days, maximum 156 days).
All restorations were manufactured intraorally with a vacuum-formed template.
Results. Mechanical and retentive characteristics revealed a high level of clinical reliability. Plaque adher-
ence of the teeth with temporary restorations was significantly increased (P=.0039) compared with the
untreated mesial reference teeth.
Conclusion. The advantageous mechanical properties of the light-curing and dual-curing materials
reviewed in dental literature were clinically offset by disadvantages in handling. (J Prosthet Dent
2000;83:32-9.)

CLINICAL IMPLICATIONS
In this study, temporary restorations made of modern composites revealed a high level
of clinical reliability. Optimized surface properties of temporary restorations were clin-
ically important to achieve limited plaque adherence. Autopolymerizing materials are
recommended from the practical point of view.

T he requirements for satisfactory provisional

restorations1-7 differ only slightly from definitive
crowns and fixed partial dentures (FPDs). Neverthe-
less, the fabrication time should be short1 and the time
of use be limited from a few weeks to half a year.8
Research on temporary restorations is almost never per-
formed in vivo.4-6,8-12 Controlled prospective clinical
trials on temporary crowns and FPDs do not exist in
the dental literature.13
Presented at the German Society of Prosthetic Dentistry and Materi-
al Sciences, Leipzig, Germany, March 1998.
Supported in part by the Vivadent Dental GmbH, Ellwangen, Ger-
many.
aSenior Doctor, Department of Prosthetic Dentistry, Technical Uni-
versity Dresden.
bDentist, Department of Prosthetic Dentistry and Materials Sciences,
Friedrich-Schiller-University.
cDentist, Department of Prosthetic Dentistry and Materials Sciences,
Bis-acryl-composite resins are more expensive and
more color stable than PMMA or polyethyl methacry-
late (PEMA),8 but show low exothermic reaction on
setting, good fit, and moderate color retention and
strength.2 Dual-curing materials show decreased
exothermic reactions and increased mechanical charac-
teristics.14 Tjan et al6 reported that light-curing (Triad
VLC) and dual-curing (Provipont, Unifast LC) materi-
als exhibited increased polymerization shrinkage and
marginal discrepancy when compared with autopoly-
merizing materials (Protemp Garant, Splintline, Jet).
Regarding discoloration, an in vitro study showed an
increased discoloration for Trim, Protemp, and Mix-
acryl.8 One in vivo study with samples in maxillary and
mandibular complete dentures evaluated differences in
discoloration between Protemp and Triad materials.15
When evaluating the periodontal response to provi-
sional materials, Garvin et al16 detected a reversible

Friedrich-Schiller-University.
gingivitis when measuring the sulcus fluid flow rate
dMathematician, Institute of Medical Statistics, Informatics and Doc- (SFFR) with the Periotron device before crown prepa-
umentation, Friedrich-Schiller-University Jena. ration, before cementation, and 2 weeks after cementa-

32 THE JOURNAL OF PROSTHETIC DENTISTRY VOLUME 83 NUMBER 1

LUTHARDT ET AL
Table I. Materials under investigation and control
Materials under investigation
Provipont (dual-curing urethane di-metharylate resin composite,
Vivadent, Schaan, Liechtenstein)
Luxatemp (self-curing bis-acryl-composite resin, DMG, Hamburg,
Germany)
Triad-VLC (visible light-curing urethane di-metharylate resin composite
35 wt% filler, Dentsply, York, Pa.)
tion. However, Sorensen et al17 observed an improve-
ment in gingival health during the provisional restora-
tion phase.
The purpose of this study was to compare the han-
dling, fit, plaque adherence, presence of gingivitis,
color stability, retention, and the subjective assessment
by the patient and the dentist of provisional restora-
tions fabricated from 4 resins. Protemp II restorative
material (Table I) is a clinically accepted composite6
compared with the recently introduced materials under
investigation. Therefore, Protemp II was chosen for
standard control.
MATERIAL AND METHODS
The design of this trial was developed according to
the Declaration of Helsinki, the European Standard
EN 540, clinical investigation of medical devices for
human subjects,19 which is equivalent to the ISO/DIS
10993-8, biologic testing of medical and dental mate-
rials and devices, Part 8,20 and the guidelines of the
ethics committee of the Friedrich-Schiller-University-
Jena. The materials, manufacturer information, and
resin types are presented in Table I.
The sample population consisted of patients of the
Department of Prosthetic Dentistry, Friedrich-Schiller-
University-Jena, who needed 2 similar fixed prosthetic
restorations (single crowns or FPDs). Temporary
restorations used as abutments for removable partial
dentures (RPDs) were excluded from the main study.
All patients with a fixed therapy concept and treatment
need according to the demands of the clinical study
were asked to participate. Patients received complete
preprosthetic diagnostics and treatment, including
standardized dental examination, intraoral or panoram-
ic radiographs, pulpal testing, an oral hygiene program,
periodontal and restorative pretreatment, and impres-
sions for complete-arch diagnostic casts.
After informing the patients of their role as partici-
pants in the clinical trial informed consent was obtained
and the material under investigation and the location of
the control were randomly assigned. For the random
assignment, one investigator opened a sealed envelope
with the name of the material under investigation. In
most instances, dental students under the supervision of
2 specially trained dentists (authors) conducted treat-
JANUARY 2000
THE JOURNAL OF PROSTHETIC DENTISTRY
Control
Protemp II (self-curing bis-acryl-composite resin, ESPE, Seefeld,
Germany)
ment. Two examiners were responsible for the supervi-
sion and the examination during therapy. The monitor
was responsible for supervision of the complete trial and
was not informed of the material under investigation.
However, the monitor was informed of the location of
this material and the control (blinded study). The mon-
itor examined the patients at all subsequent appoint-
ments for which treatment of these teeth was scheduled.
The clinical procedure was standardized. A detailed
manual listing the requirements of all possible treat-
ment steps, including the method of investigation was
used. Techniques using a vacuum-thermoformed clear
splint matrix6,18 or an irreversible hydrocolloid impres-
sion7 for fabricating provisional restorations of light-
initiated materials have been described.
All restorations were made with a vacuum-thermo-
formed clear splint matrix (Drufolen H polypropy-
lene, Dreve-Dentamid, Unna, Germany)6 to create a
homogeneous clinical method for autopolymerizing,
dual-curing and light-initiated provisional materials.
The clear matrix was fabricated on complete-arch
diagnostic casts, where the marginal areas of teeth to
be restored were strengthened and all required alter-
ations of shape and position were performed with
acrylic resin. The restorations of autopolymerizing
and dual-curing materials were made according to the
manufacturer’s recommendations. In addition, for the
light-curing material, the clinical description by Pas-
son and Goldfogel18 was used. Each temporary
restoration was checked by one of the examiners
before setting. The criteria were clinically, well-fitting
temporary restorations according to the guidelines
(Fig. 1, mark 1): (1) absence of chipping, cracks and
voids, (2) occlusal contact points checked with shim
stock for the restored teeth and the mesial adjacent
teeth, and (3) checked with Tofflemire-matrix (0.035
mm thickness) without interdental spacing.
Temporary restorations were trimmed with fine HM-
cutters (Komet, Brasseler Gmbh & Co Kg, Lerngo, Ger-
many), polished with silicone polishers, and set with
Provilink provisional dual-curing composite (Vivadent,
Schaan, Liechtenstein). Excess provisional cement was
removed with probe and scaler. Afterward, the clinical
situation was rechecked by one of the examiners. Each
patient was instructed in oral hygiene during the pre-
33
THE JOURNAL OF PROSTHETIC DENTISTRY LUTHARDT ET AL

Fig. 1. Criteria for assessment of mechanical properties.

Table II. Conditions for treatment failure (score 5)

Clinically not acceptable handling
Not acceptable mechanical behavior
Repeated manufacturing
Not acceptable color
Impossible removing out of clear matrix (deformation, crack)
Uncompleted polymerization
Not acceptable occlusal fitting
Not acceptable subjective assessment by the dentist with necessity for repeated manufacturing
Marginal chipping > 1 mm in height, cracks, perforation if caused by abrasion
Loss of occlusal contacts and interdental spacing
Subjective assessment by the patient: repeated manufacturing necessary
Lost retention and necessity of repeated manufacturing
Color considerably too light or too dark
Not acceptable discoloration

treatment phase and was provided with written instruc-
tions for the period of temporary restoration.
Criteria for treatment failure
The clinical trial was designed to indicate significant
differences between temporary restorations of
Provipont, Luxatemp, and Triad materials compared
with Protemp II material (control). The null hypothe-
sis considered the 4 materials to be equivalent. The
treatment was considered a failure when any conditions
listed in Table II occurred. The assessment was based
on a system of modified CDA criteria.21 For temporary
restorations, only 2 positive ratings (clinically good,
clinically sufficient) and 1 negative rating (not accept-
able) were necessary (Fig. 1).
Pretreatment data (Table III) were collected by 1 of
the examiners after the random selection of the materi-
als. The Plaque Index (PI) and papilla bleeding index
(PBI) were collected at the mesial interproximal surface
of the adjacent tooth (reference) and the distal surface of
the treated tooth. The study design was evaluated with
a pilot study that used 14 nonstudy patients (28 restora-
tions). During this period, the examiners and the moni-
tor received training in data collection procedures and
examination. Distribution of single crowns, three-quar-
ter crowns, connected crowns, and FPDs in the study
sample according to the material used is shown in Table
IV. One patient included in the study was treated with 2
of the materials under investigation. The mean time of
treatment was 37.5 days (minimum 2 days, maximum

34 VOLUME 83 NUMBER 1
LUTHARDT ET AL THE JOURNAL OF PROSTHETIC DENTISTRY

Fig. 2. Left, Initial occlusal fitting of temporary restorations. Right, Dentist’s assessment of tem-
porary restorations (score 1 very good, score 3 acceptable, score 5 not acceptable, drop out).

Table III. Collected pretreatment data Table IV. Study sample

Gender Fixed
Single Three-quarter Connected partial
Medical history
crowns crown crowns dentures Total
Plaque Index (PI)
Bleeding on probing, according to the PBI with a rating scale of 0 Protemp II 12 1 4 13 30
to 3 of the treated and adjacent teeth Provipont 3 0 3 4 10
Examination of the oral mucosa Luxatemp 1 0 2 9 12
Tooth mobility tested with the Periotest instrument (Siemens, Triad 4 1 0 4 9
Bensheim, Germany) Total 20 2 9 30 61

156 days). Time of treatment was defined as the period
between the fabrication of the temporary restoration
and the next appointment when treatment of the teeth
under investigation or impression making in this jaw was
performed. The final clinical evaluation was performed
before any subsequent treatment.
Statistical analysis
Different handling characteristics were examined dur-
ing the manufacturing of the temporary restoration. Cri-
teria for assessments of handling are presented in Table
V. Patients were instructed to contact the Department of
Prosthetic Dentistry if they noticed any changes to the
temporary restoration. The scores for PI and PBI are
sampled with the procedure mentioned previously. Dif-
ferences between pretreatment and posttreatment scores
were analyzed. Negative ratios (decreased plaque or
bleeding), no changes, and positive ratios (increased
plaque or bleeding) were expected. For analysis of
Table V. Criteria for handling
Removability of the restoration from the prepared teeth
Removability of the restoration out of vacuum-formed template
Changes in fitting during polymerization and removal
Incomplete polymerization
Occlusal fitting
Subjective assessment of handling by the dentist
changes in PI and PBI, the negative ratios and no
change results were combined in 1 group, the positive
ratios to another. The McNemar test (SPSS for MS
Windows [Version 6.1], SPSS Gmbh, Munich, Ger-
many) for dependent samples was used to demonstrate
significant differences between the control and the
materials under investigation. Significant differences
between the materials under investigation were analyzed
with the chi-square test (independent samples).

JANUARY 2000 35
THE JOURNAL OF PROSTHETIC DENTISTRY LUTHARDT ET AL

Fig. 3. Left, Plaque adherence (PI) at teeth with temporary restorations (Protemp II) compared
with untreated reference. Right, Bleeding (PBI) at teeth with temporary restorations (Protemp
II) compared with untreated reference.

Fig. 4. Left, Mechanical characteristics (integrity, occlusal contact points and interdental spac-
ing) of temporary restorations. Right, Integrity of temporary restorations (score 1 very good,
score 3 acceptable, score 5 not acceptable, drop out).

The assessment of the mechanical behavior included ing to the guidelines pictured in Figure 1. Changes in
changes in the integrity, occlusal contact points, and color were scored visually (no, slight, or not acceptable
interdental spacing. The clinical examination was per- discoloration) with a sample of the material polymer-
formed with probe and mirror by the monitor accord- ized on a smooth glass surface at the date of fabrication

36 VOLUME 83 NUMBER 1
LUTHARDT ET AL THE JOURNAL OF PROSTHETIC DENTISTRY

Fig. 5. Mechanical and retentive characteristics for all temporary restorations.

and stored in an envelope. The patient was asked for his Table VI. Number of trials necessary to manufacture tempo-
or her subjective assessment, choosing the subjective rary restorations, according to guidelines
estimation out of 3 possible answers (very satisfied, suf- Number of trials
ficient, or not acceptable). Statistical analysis of the 1 2 3 >3 Drop out
materials and the control was performed with the sign-
test (dependent samples, level of confidence P=.05). Protemp II 83.3% 10.0% 0.0% 6.6% 0.0%
Provipont 70.0% 10.0% 10.0% 10.0% 0.0%
Comparison of materials was performed using the chi-
Luxatemp 91.6% 8.3% 0.0% 0.0% 0.0%
square test (dependent samples, multiple level of signif-
Triad 77.7% 0.0% 11.1% 0.0% 11.1%
icance λ=0.05).
RESULTS
Handling proximal spacing, and occlusal contacts and is repre-
The assessment of the removability from the prepared sented by the worst scores. Clinically unacceptable
teeth and from the vacuum-formed template was judged assessments of the mechanical characteristics resulted
as good or sufficient for almost all cases. The polymer- from the assessments of integrity in 4 cases (Fig. 4,
ization of the composite was clinically complete. Table VI right). Figure 5 illustrates the mechanical and retentive
presents the number of trials necessary to manufacture characteristics for all restorations. Three patients (5%)
temporary restorations according to the guidelines listed. visited the Department before the next fixed appoint-
Figure 2 illustrates the initial occlusal fitting and the den- ment for lost retention and received a rebonding of the
tist’s assessment of the restoration. restoration.
Changes in periodontal health of treated and Color stability, subjective assessment, and
untreated teeth treatment failure
The plaque adherence (PI) of the teeth with tempo- Only 2 cases of unacceptable discoloration (Fig. 6,
rary restorations was significantly increased in compari- left) were combined with a negative assessment of the
son to the untreated reference (P=.0039, λ = 0.05) temporary restoration by the patient (Fig. 6, right).
(Fig. 3, left). Bleeding (PBI) did not show significant The rating of the restorations by the patient was very
changes of the scores before and after treatment (Fig. 3, good without significant differences between the mate-
right). Changes of the oral mucosa were not detectable. rials. Treatment failures (Fig. 1, score 5) occurred in
some patients. Unacceptable clinical handling was
Mechanical and retentive characteristics
detected 6 times. Treatment failures occurred in 4 cases
Figure 4 (left side) lists the scores of integrity, inter- of unacceptable assessments of integrity, resulting from

JANUARY 2000 37
THE JOURNAL OF PROSTHETIC DENTISTRY
Fig. 6. Left, Discoloration of temporary restorations. Right, Assessment of temporary restora-
tion by patient of temporary restorations (score 1 very good, score 3 acceptable, score 5 not
acceptable, drop out).
cracks (1 each of Protemp II, Provipont, and Triad
materials) and marginal chipping (Provipont). Loss of
retention did not occur in these cases, but 3 temporary
restorations lost retention and were rebonded without
repair or remanufacturing. Because no repair or reman-
ufacturing was necessary, these 3 cases were not classi-
fied as treatment failure.
DISCUSSION
To our knowledge, no other prospective clinical trial
has been conducted to test and compare the quality
and handling of commonly used composites for tem-
porary restorations. In our study, most temporary
restorations were manufactured with only 1 trial,
despite the high quality standard necessary to fulfill the
guidelines. No patients were lost during follow-up, but
dropout of single results occurred in some cases
because of incomplete manufacturing of test samples
(discoloration).
Despite the first polymerization step directly on the
prepared teeth, the inner surface of the temporary
restoration was too small, because of polymerization
shrinkage. Clinically, the restoration showed an
increased marginal gap and occlusal supracontacts.6
Only 50% of the dentists assessed the handling of the
autopolymerizing materials as very good and the assess-
ment of the dual-curing material was significantly worse
(α=.05, P=.0313) than the control. This study supports
other findings that light- and dual-curing materials show
38
LUTHARDT ET AL
increased polymerization shrinkage and marginal dis-
crepancy compared with autopolymerizing materials.6
Garvin et al16 showed that at the end of treatment
with temporary restorations, a reversible gingivitis was
detectable, but the procedure used in fabricating the
temporary restorations was not described. Another
study observed an improvement in gingival health dur-
ing the provisional restoration phase,17 but there was
no untreated control. Our study showed that there was
an increased plaque adherence, but no gingivitis during
an average treatment period of 37.5 days. The plaque
adherence was not only limited to the trimmed and
polished marginal areas but was also located at the
smooth surface of the temporary restorations manufac-
tured with a vacuum-formed template. Therefore,
plaque adherence should be attributed to the proper-
ties of the composite itself. An in vitro study detected
an increased discoloration for all materials tested with
the exception of the PMMA-resin Cold Pac (Motloid,
Chicago, Ill.),8 whereas an in vivo study with samples
in maxillary and mandibular complete dentures evalu-
ated differences between Protemp and Triad.15 Thus,
clinical examination indicated a moderate discoloration
of all materials but nonacceptable discoloration in 2
restorations fabricated with Triad-VLC material.
Patient satisfaction was not influenced by the moderate
discoloration, but the subjective assessment by the
patients treated with 2 restorations fabricated with
Triad-VLC material was unacceptable.
VOLUME 83 NUMBER 1
LUTHARDT ET AL
The mechanical demands were fulfilled by most of
the temporary restorations (ratings of very good or suf-
ficient). In particular, the retention (95% without loss
of retention) revealed the standard of clinical quality
and the good properties of the provisional cement.
Negative estimation was caused by the worst assess-
ment of the integrity (marginal chipping, fracture,
voids, and abrasion with perforation). Finally, there is
the question of whether the light- and dual-curing
materials offered a clinical benefit. Gegauff and Wilker-
son9 reported significantly higher fracture toughness in
vitro for Triad-VLC compared with 3 materials. Triad-
VLC was the only composite in their study that was
contrary to our study of 4 composites; however, they
detected a reduction of fracture toughness of 40% using
a simulated direct procedure and recommended the
material, dependent on adequate flexibility and patients’
safety considerations.9 The results of this simulated
clinical procedure were confirmed by the increased rate
of defects (integrity) and difficulties in handling caused
by reduced flexibility of the partially polymerized mate-
rial in our study. These findings are supported by Tjan
et al,6 who reported extreme technique sensitivity of
Provipont material. Moulding et al10 described a sig-
nificantly increased marginal discrepancy caused by
removing the temporary restoration during fabrication.
Thus, when the different fabrication techniques used
for light- and dual-curing materials are compared with
chemically initiated resins, the technique itself might be
another reason for poor marginal accuracy.6 The supe-
rior mechanical properties of light- and dual-curing
composites in vitro9 did not positively influence the
clinical results.
CONCLUSIONS
Fabricating temporary restorations with the clear-
matrix technique reduced the surface roughness. How-
ever, plaque adherence was significantly higher on the
temporary restorations than on the adjacent untreated
reference tooth. Mechanical and retentive characteris-
tics of temporary restorations made of Protemp II,
Provipont, Luxatemp, and Triad materials exhibited a
high level of clinical reliability. A satisfactory initial
accuracy of the occlusal fit was difficult to achieve
because of the polymerization shrinkage. For this rea-
son, all materials, especially the light- and dual-curing
ones, performed worse in the subjective assessment of
handling by the dentists than in the assessment of the
mechanical properties or patient’s assessment. The
advantageous material properties shown by light- and
dual-cure acrylic resins in vitro were clinically offset by
disadvantages in handling.
JANUARY 2000
THE JOURNAL OF PROSTHETIC DENTISTRY
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Reprint requests to:
DR RALPH G. LUTHARDT
UNIVERSITY HOSPITAL CARL GUSTAV CARUS DRESDEN
DEPARTMENT OF PROSTHETIC DENTISTRY
FETSCHERSTRAßE 74
01307 DRESDEN
GERMANY
FAX: (49)351-4585314
E-MAIL: Ralph.Luthardt@mailbox.tu-dresden.de
Copyright © 2000 by The Editorial Council of The Journal of Prosthetic
Dentistry.
0022-3913/2000/$12.00 + 0. 10/1/103320
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