Assessment of Factors Affecting Partial Removable Dental Prostheses Framework Fit: A

Clinical Prospective Study

Purpose: To prospectively evaluate the effects of impression material, impression tray type,
and partially dentate arch classification on the accuracy of fit of partial removable dental
prostheses (PRDP) cobalt-chromium (Co-Cr) frameworks, as inferred from the number of
fabricated frameworks required for achievement of acceptable fit. Materials and Methods:
A total of 103 partially dentate patients provided with Co-Cr PRDP treatment for one or both
arches (n = 142) by undergraduate dental students were clinically assessed by two examiners
at the metal framework try-in stage, and the relevant data were recorded. Statistical analyses
of data were performed using factorial analysis of variance (ANOVA) to study the
associations of impression material (alginate, polyvinyl siloxane [PVS]), Kennedy class, and
impression tray type (stock, custom) with the number of frameworks that needed to be
fabricated for each patient (α = .05). Results: Statistical analyses of data derived from 142
(65 maxillary and 77 mandibular) treated partially edentulous arches revealed no significant
correlation between the impression material, Kennedy class, or tray type with respect to the
number of framework construction attempts needed (P ≥ .05). Post hoc Tukey test also did
not demonstrate any significant differences between the different Kennedy classes in relation
to the set outcome measure (P ≥ .05). Conclusion: Alginate as an alternative option to PVS
and modified metal stock trays can be used for making final impressions to produce PRDP
Co-Cr frameworks. Framework fit is unaffected by class of partial edentulism (Kennedy
class).

Adequacy of framework fit is a fundamental requirement for cobalt-chromi-um (Co-Cr)

partial removable dental prostheses (PRDPs). 1,2 In clinical practice, visual and tactile
inspection with a mouth mirror and dental explorer have often been the preferred method to
check the acceptability of framework fit, based on the guidelines of a number of specialist
societies.1,3,4 These guidelines state that fit is judged as good if all rests are completely seated
in position in their corresponding rest seats, if all rigid framework components snugly contact
the teeth, and if the in- taglio surface of the major connector does not press against the soft
tissue or exhibit a detectable gap of more than 1 mm. 1–5 A number of clinical and laboratory
factors have been implicated as potentially influencing the fit of PRDP Co-Cr frameworks. 6–11
In particular, the effects of impression material and impression tray type have been the
subject of multiple investigations, although clear-cut evidence of the decisive roles of these
factors is still lacking.7,8,10,11 As regards impression material, irreversible hydrocolloid
(alginate) has been pro- posed by several authors as a substitute for elastomeric impression
materials in Co-Cr PRDP framework construction. 7,12–15 Regarding usage patterns, alginate
has been re- ported as the predominantly used final impression material according to some
dental school–based surveys and private dental laboratory data. 12,14,15 Elsewhere, greater usage
has been reported for elastomers as the impression material for the fabrication of PRDP metal
frameworks.16
A limited number of studies have examined the role of impression material in affecting the fit
of PRDP Co- Cr frameworks. One such study that compared alginate and condensation
silicone found significant differences between the two in terms of accuracy of intraoral fit of
Co-Cr frameworks.6 An in vitro study examined the effect of impression material on fit by
assessing accuracy using scans of the casts without actual fabrication of the frameworks to
evaluate the fit directly.7 Reports on the effectiveness of alginate as a final impression mate-
rial have largely been restricted to either in vitro studies 7 or retrospective evaluations.10,16 The
only prospective clinical study that examined the fit of Co-Cr PRDPs at the try-in, delivery,
and post-insertion stages in a university setting concluded that the fit was unaffected by the
use of alginate or addition-cured polyvinyl siloxane (PVS) impression materials in custom
trays.11
With regard to pattern of partial edentulism and framework fit, a significant difference
between the fit of the framework rests in a group of mandibular Kennedy classes I and II
PRDP frameworks compared to a group of Kennedy classes III and IV frameworks has been
reported.17 On the other hand, another retrospective study found no correlation between
partially edentulous arch configuration and metal framework adaptation. 10 The possible
effects of the pattern of partial edentulism, based on Kennedy classification, on the overall fit
of PRDP Co-Cr frameworks remains unclear. Practice guidelines generally advocate either a
custom tray or a modified metal stock tray for secondary impressions in partial denture
treatment.1,3 Whereas some studies have found that master casts poured from impressions
produced using stock trays are not as dimensionally accurate as those made using custom
trays,8,9 the effect of tray choice on the PRDP metal framework fit remains ambiguous.
Given the above-stated doubts regarding the possible roles of impression material, partially
edentulous arch classification, and impression tray type on the accuracy of framework fit, this
study aimed to prospectively examine patients treated with PRDPs in an undergraduate dental
teaching clinic for any correlation that may exist between these variables and the number of
fabricated frameworks needed until the attainment of adequate fit. The null hypotheses were
that there would be no differences between alginate and addition silicone impression
materials with respect to achievement of framework fit, as inferred from the number of
frame- work repeats needed for achievement of a satisfactory result; and secondarily, that
there would be no correla- tion between the partially edentulous arch classification or
impression tray type and number of frameworks that need to be fabricated for each patient
until achievement of satisfactory fit.
MATERIALS AND METHODS
The study was comprised of 103 patients (144 partially dentate arches) drawn sequentially
and on a PRDP need-to-treat basis from patients undergoing comprehensive dental care in an
undergraduate dental teaching clinic during the period of February 1, 2017, to April 30, 2019.
The sample size required for the study had been estimated to be 93 partially dentate
arches/frameworks (47 in each impression group) for a least significant difference between
the two groups of 1 attempt and a standard deviation estimated as 0.34.10 This was based on
90% power of the study and a .05 significance level.
Inclusion Criteria
Partially dentate patients who were planned for Co-Cr PRDP treatment for one or both arches
as part of their comprehensive dental care and had PRDPs provided by undergraduate dental
students under supervision of a specialist prosthodontic faculty member were included.
Informed consent was obtained after explanation of the purpose and nature of the study at the
initial patient screening performed by relevant clinical staff and/ or by the supervising
prosthodontic staff at the commencement of the PRDP treatment. Patients were clearly
informed that their treatment would be performed according to the standard clinical protocols
of the university dental clinic. Ethical approval was obtained from the institutional ethical
committee, and permission to conduct the study during the undergraduate clinical course was
obtained from the Faculty of Dentistry clinical committee. For all patients, demographic data,
arch type, Kennedy class, impression material, tray type, and the number of fabrication
attempts of the frameworks needed to achieve a clinically acceptable fit for each of the dental
arches were noted. The investigation was conducted using a single-blinded design—although
the students were aware that the patients were participating in a clinical trial, they were
blinded to the test variables. The primary dependent variables, namely choice of impression
material and tray type, were at the discretion of the supervising prosthodontic staff based on
their inde- pendent evaluation of the clinical features of the case and guided by the standard
clinical protocols followed in the university dental clinic. 1–4 Since the setting was an
undergraduate teaching clinic, the supervisor engaged the student in the choice of material
and tray to be used, thus reinforcing the principles that they were taught. It also follows that,
since patients were enrolled on a sequential, need-to-treat basis and on the aforementioned
clinical protocols recommended for various clinical conditions, the question of randomization
did not arise.
Fabrication of Metal Frameworks
Conventional clinical protocols were observed in the planning, design, and implementation of
all phases of the PRDP treatment: this included surveying and designing the denture on the
master cast and communicating the design to the laboratory by means of a laborato- ry
prescription sheet, along with written instructions. All steps were checked and signed off by
the super- vising faculty. The same brands of impression materials (alginate, Alginmax,
Major Prodotti Dentari S.p.A; PVS, Express XT Penta Putty and Light Body, 3M ESPE)
were used throughout the clinical trial for all cases, thus maintaining impression material
uniformity. Impres- sion trays used were either perforated rim-lock dentate metal stock trays
(COE metal impression trays, GC) or light-cured acrylic resin custom trays (Preci Tray, Yeti
Dentalprodukte) with/without border molding (impression compound, Kerr) as required. The
metal frame- works were manufactured in the university production dental laboratory by in-
house dental technicians per the laboratory prescription following standard procedures,
including conventional wax-up technique (Model casting waxes, Yeti Dentalprodukte) and
casting in Co-Cr alloy (Solidur CoCr, Yeti Dentalprodukte).
Framework Evaluation
Initial examination of the framework at the try-in stage was performed by the dental student,
guided by the supervising prosthodontic faculty. Two prosthodontists then assessed the
frameworks. While both knew the purpose and design of the study, only one (the supervising
prosthodontic faculty) had knowledge of the impression material/tray group to which the
patient belonged; the other prosthodontist aided only in the confirmation of framework fit
independently as a second evaluator. In cases of disagreement between the two examiners
regarding framework fit acceptability, a third blinded prosthodontist was engaged as an
arbitrator, and a mutual decision was then agreed upon as to whether the framework was to
be accepted or repeated. The criteria applied for in vivo assessment of framework fit were
drawn from previously published guidelines1–4 that form the basis for standard practice
among all members of the discipline within the dental school: All rigid elements of the
framework, including parts of major connectors, clasps, and guide plates, must be verified as
having an intimate, nonbinding contact with the teeth. The major connector must conform
passively to the supporting tissues without evidence of stress or exhibiting a space of > 1 mm
between the fitting surface and the tissues. Stability and accuracy of fit were judged on the
basis of no detectable gaps between rest seats and rests using a dental explorer. Additionally,
a silicone fit checker applied to the intaglio surface of the framework permitted examination
of the proximity of framework seating by demonstrating no conspicuous internal fit
discrepancies in the region of the rests. The fit checker record was both visually assessed and
objectively analyzed using an Iwansson (dial) caliper. Since there are no clear-cut
quantitative guidelines regarding what constitutes acceptable internal gaps in the region of the
rests, clinical judgement was relied upon to determine the level of discrepancy, if any, and to
decide on the acceptability of the framework.
In the region of the major connectors, besides the visual and tactile examination using a
dental explorer, the fit was also confirmed using silicone fit checker material. The
frameworks were also checked for visible spaces between clasps and abutment teeth and
further confirmed using a dental explorer tip and/or orthodontic wire of 0.5-mm diameter.
Frameworks that did not meet the qualitative assessment criteria were deemed unacceptable
and were rejected. New frameworks were then fabricated, again following the standard
protocol of new definitive impressions, and the same proce- dure of checks was followed at
the subsequent try-in attempt(s). For all intents and purposes, this documented standard of
care served as a means of indirect calibration for the clinical assessment of framework fit,
while the role of the second examiner strengthened the accuracy and consistency of the
assessment procedure. Frameworks were accepted if all the noted assessment criteria were
satisfied with no discernible defects noted; if a frame- work did not meet all of the
acceptability criteria, then a remake was required.
Statistical Analyses
Descriptive statistics were carried out, and factorial analysis of variance (ANOVA) was used
to compare the relationships of impression material, Kennedy class, and tray type with the
number of frameworks fabricated for each patient (SPSS v. 20) at α = .05 for both maxillary
and mandibular arches together. Post hoc Tukey tests were further performed to compare the
means of the different Kennedy classes in terms of number of frame- work attempts.
RESULTS
A total of 142 treated partially dentate arches (65 maxillary; 77 mandibular) were analyzed,
and the descriptive characteristics of the studied sample are presented in Table 1. For all
cases, alginate or PVS impression materials were used with modified metal stock or light-
cured custom trays. With regards to the distribution of arch configuration type, similar
numbers were recorded for two Kennedy classes: class I (51) and class III (54), with Kennedy
class II (37) showing the least representation (Table 1). Of all the PRDP frameworks made,
52 (37%) were fabricated from PVS impressions and 90 (63%) from alginate. The total
number of framework construction attempts for any given case did not exceed 2. A total of
124 (87%) frameworks “passed” in the first attempt, and the remaining 18 (13%) frameworks
required remake due to improper fit at the first try. Of the frameworks made from alginate
impressions, 85% (76) “passed” on the first attempt compared to 92% (48) with PVS. A
majority of alginate and PVS impressions were performed using modified metal stock trays
(111/142). The two examiners independently showed total agreement regarding their
decisions on the fit of all the frameworks, precluding the need for mediation from the stand-in
arbitrator. Analyses of the relationships between the number of construction attempts and the
differ- ent variables are shown in Table 2. Statistical analyses of the data performed using
ANOVA revealed no significant correlation between the interactions of impression material,
tray type, or Kennedy class and the number of construction attempts for the consolidated
maxillary and mandibular arches (P ≥ .05) (Table 2). Post hoc Tukey HSD tests further
exhibited no significant differences between the three Kennedy classes in relation to
framework fit, as inferred from the number of framework attempts (P ≥ .05).
DISCUSSION
This prospective clinical study based on assessment of partially dentate patients who had
been provided with PRDPs in an undergraduate dental teaching clinic sought to analyze the
association of various factors with respect to the production of clinically acceptable metal
framework fit, as inferred from the number of framework construction attempts that needed
to be made to achieve the result. The factors that were assessed for possible correla- tion with
framework fit were: choice of final impression material (ie, alginate or PVS); pattern of
partial edentulism (ie, Kennedy class); and choice of impression tray (ie, light cured custom
or metal stock trays).
Overall, no difference with respect to framework fit between the two materials used as a final
impres- sion material was found, regardless of the tray type, Kennedy class, and arch type.
Similarly, there were no correlations between the pattern of partial edentulism (Kennedy
class) and impression tray type in relation to the number of frameworks that needed to be
fabricated per partially edentulous arch. Based on these findings, it follows that the null
hypotheses failed to get rejected.
The findings of this paper corroborate those of a recent clinical study 11 that found no
differences between alginate and PVS in terms of fit of PRDPs at different stages of
evaluation. However, it should be noted that only custom impression trays were used in that
investigation, whereas the current study engaged a mix of stock metal and light-cured acrylic
custom trays. Additionally, the number of patients/ PRDPs (49/56) was far fewer in the
earlier investigation compared to the current one. These results also concur with another
retrospective clinical evaluation10 and an in vitro study7 that showed insignificant statistical
differences in relation to use of alginate or PVS in terms of Co-Cr PRDP metal framework
fit. On the other hand, these findings differ from those of an earlier clinical study 6 that found
significant differences between conden- sation silicone and alginate in terms of intraoral fit of
PRDPs. There could be various factors attributable to the disagreement, notably differences
in the actual im- pression material products that were employed in the two studies,
differences in laboratory-related processes, and differences in the test parameters that were
used. Regarding the pattern of partial edentulism, the finding of no significant correlation
with framework fit con- trasts findings of an earlier investigation 17 that found differences
between the various mandibular Kennedy classes in terms of metal framework rest
adaptation. In the present study, framework fit was not assessed by quantifying the space
between the rests and the rest seats at four different locations, as was done in the cited
investigation.17 Rather, framework fit was evaluated clinically by applying textbook-
recommended assess- ment standards,1–4 including the use of silicone-based disclosing
medium to confirm fit and to detect any discrepancies at the framework try-in appointment. It
can be noted that the role of variations in modification spaces in the dental arches between
the two studies could have also contributed to the effect. The current study results, however,
found agreement with another recent clinical evaluation 10 that also found no effect of partially
dentate arch type on framework fit. Due to an absence of more closely matching published
clinical studies, further comparison with the existing results on this aspect was not possible.
The last factor investigated was tray type, which was again not correlated with the fit of the
PRDP metal frameworks. The reasons for preferring stock trays over custom trays, as noted
in many clinical and in vitro studies, include their ready availability, cost effectiveness, and
varieties of design. It is worth noting that only met- al stock trays were utilized in this study,
and the results could have been different if plastic stock trays were used instead, given their
known shortcomings in terms of rigidity and design factors.8–10
It is known that variations in laboratory processes can potentially affect the fit of PRDP metal
frameworks, including the type of dental stone used, impression pouring technique,
investment material type, spruing technique, type of alloy used, and the fitting and polishing
techniques on the master cast, among others. By virtue of all the frameworks in the present
study having been fabricated in the in-house production laboratory, uniformity in all phases
of the production cycle can be said to have been maintained. Moreover, stringent quality
control measures were applied on every framework before approval for transfer to the clinic
for patient try-in. Thus, it may be fair to infer that a homogenous approach to laboratory
fabrication of frameworks coupled with the adherence to set clinical protocols by a closely
monitored clinical dental student would have favorably impacted the study outcomes, as
suggested by the 87% success with framework fit at the first attempt. It can be speculated that
the outcome may have been different if treatment had been provided in a less standardized
setting.
The central question addressed in this investigation was whether the fit of the PRDP
framework was, upon initial clinical insertion, associated with specified clinical variables.
The definitive evaluation of acceptable fit of frameworks was made by two experienced
specialist prosthodontic staff teaching in the same undergraduate institutional setting for
several years. Their decisions with respect to framework fit were independently agreed upon
in each case, and it is suggested that this served to strengthen the reliability of the results.
There are some probable limitations of the study that can be stated. For one, there were
considerably fewer cases that employed custom acrylic trays compared to the metal stock
trays, and such disparate numbers may potentially unfavorably influence the validity of the
results. Likewise, the very few cases of Kennedy class IV partial edentulism in the current
sample prompted elimination of this class from statistical analysis, compromising the reliable
examination of the role of arch configuration. The number of cases was also unevenly
distributed among the impression material categories. However, it needs to be noted that in
this prospective study, the independent variables (impression material, tray type) were not
randomly allocated to the patients to ensure equal sample sizes for comparison purposes. It
was instead the judgement of the supervising prosthodontist based on his/her individual
assessment of the patient, guided by the clinical standards of care agreed upon by all staff
working in the discipline. Also, all prosthodontists guiding students in the university clinic
acted independently of the two prosthodontists who checked the fit of the frameworks.
Another possible critique might be in the way the framework fit was examined. While it was
not an objectively quantitative method, the evaluation was done by members of a clinical
academic department, all of whom were guided by the clinical standards of care agreed upon
by all staff working in the discipline. The only quantitative analysis of the frameworks was
the evaluation of the thickness of silicone fit check records in the region of the rests and
major connector using an Iwansson (dial) caliper. A few previous studies 17–19 have analyzed
the silicone fit records using stereo-micro- scopes or other measurement techniques in the
laboratory to compare the discrepancy of fit. However, such an evaluation is not a realistic
option in clinical practice. In fact, to date, no clear quantitative guidelines exist to determine
the acceptability of fit of the frameworks in the “rest” areas; rather, clinical judgement relies
on the qualitative assessment of the PRDP framework. Indeed, minor differences in the
spaces or lack of close adaptation between the rests and rest seats at different locations within
a given rest or between different rests in a framework may not be clinically significant as
long as the framework is stable and there are no discernible margin- al defects at the junction
of the rests and the rest seats. Randomized controlled clinical trials with larger sample sizes
need to be conducted in the future to further validate the results of this prospective clinical
study. Nevertheless, these results suggest that the final impression material and tray system
used in the fabrication of Co-Cr PRDPs may require reconsideration. This would also be
synchronous with the Appropriatech concept,20 which advocates an evidence based, cost-
effective approach for achieving clinical results.
CONCLUSIONS
Based on the limitations of this study, it can be concluded:
Irreversible hydrocolloid (alginate) can be used as an alternative final impression material in
the fabrication of Co-Cr frameworks in PRDP treatment. Metal stock trays can be routinely
employed for performing final impressions in the construction of Co-Cr PRDPs. Arch
configuration (Kennedy class) did not affect the fit of the Co-Cr PRDP frameworks.
Table 1 Descriptive Analysis of the 142 Frameworks of Partially Dentate Arches
Prospectively Evaluated in this Study
Table 2 Correlation of interactions among impression material, kennedy class, and tray type
with number of frameworks fabricated until acceptable fit (n=142)
Analysis of variance. Df= degree of freedom