journal of dentistry 38 (2010) 853858

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A cross-over Randomised Controlled Trial of selective

pressure impressions for lower complete dentures
T.P. Hyde a,*, H.L. Craddock a, A. Blance b, P.A. Brunton a
a

Operative Dentistry, Leeds Dental Institute, Clarendon Way, University of Leeds, Leeds LS2 9LU, United Kingdom
Division of Biostatistics, Leeds Institute of Genetics, Health & Therapeutics, Clarendon Way, University of Leeds, Leeds LS2 9JT,
United Kingdom

article info

abstract

Article history:

Objectives: The objective of the research was to assess patient preference for a selective

Received 11 May 2010

pressure impression technique for complete dentures by means of a Randomised Controlled

Received in revised form

Clinical Trial (RCT).

7 July 2010

Methods: A literature review revealed no reported RCTs of selective pressure impressions

Accepted 8 July 2010

for complete dentures. A cross-over, randomised, controlled, clinical trial was performed
comparing selective pressure impressions with a placebo and an alternative method of redistributing pressure. A sample size calculation yielded 65 patients. Sixty-nine patients, who

Keywords:

had a superficial mental foramen on the lower denture bearing area, were recruited for the

Randomised

study. The primary outcome was the patients preference of the dentures provided. The

Trial

hypothesis under investigation was that one of the dentures would be preferred by the

Denture

patients.

Impression

Results: Sixty-six participants completed the trial, 33 (50%) preferred the denture from the

RCT

selective pressure impression, 19 (29%) the denture with traditional pressure relief, and 14
(21%) the placebo control. 95% confidence intervals showed that the preference for the
selective pressure impression was greater than that of the other two techniques. The null
hypothesis was rejected.
Conclusions: The participants in this trial showed a preference for the denture constructed
from the selective pressure impression technique, providing dentists with useful evidence
for a clinical impression technique.
# 2010 Elsevier Ltd. All rights reserved.

1.

Introduction

The dental academic literature has many papers, case

histories and textbooks written on the subject of impressions
for complete dentures. Four broad concepts for impressions
have been described: Muco-displacing,1 Mucostatic,2,3 Selective Pressure48 and Functional9,10 Impressions. These impression techniques have been suggested and developed to
record the denture bearing tissues in various states of
displacement, and to manage particular clinical situations.

The different states of tissue displacement are said to be

achieved by variations in pressure within the impression. The
evidence for pressure variation with impressions comes from
the laboratory experiments by Frank,11 Komiyama,12 Masri,13
Al-Ahmad14 and Hyde15 who have all have shown variation in
the pressure of impressions in vitro. However, the level of in
vivo evidence and in particular the clinical evidence for
particular impression techniques is poor and needs careful
consideration.
Within the prosthodontic literature, there is a paucity of
high quality evidence in the form of Randomised Controlled

* Corresponding author. Tel.: +44 0113 343 8515; fax: +44 0113 343 6236.
E-mail address: T.P.Hyde@Leeds.ac.uk (T.P. Hyde).
0300-5712/$ see front matter # 2010 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jdent.2010.07.003

854

journal of dentistry 38 (2010) 853858

Fig. 1 Resorption of the mandible in trial patients. (Left) The typical clinical appearance and (Right) the typical radiological
appearance.

Trials (RCTs) for any specific impression technique.16,17 There

have been only two reported Randomised Controlled Trials, by
Firtell18 and McCord,19 which have investigated clinical
impressions for complete dentures. Neither study investigated
selective pressure impressions. Firtells18 study found no
evidence of a statistically significant preference for an
impression material. McCord reported problems with randomisation in his study and with just 11 patients looking at three
impression techniques the study was underpowered. The
evidence for the clinical benefits of impressions for complete
dentures is therefore based on expert opinion backed by the
anecdotal evidence of case histories. These form a lower level
of evidence than an RCT. One such case history was presented
by Hyde.5 He purported to show how to distribute pressure in a
selective pressure impression using modern materials. Since
there have been no previously reported RCTs of selective
pressure impressions for complete dentures, a Randomised
Controlled Trial was indicated.
Before an RCT of selective pressure impressions could be
carried out, it became necessary to identify a relatively
homogeneous group of patients, who would benefit from a
selective pressure impression technique. There are particular
problems providing dentures for patients who have been
edentulous for many years. These problems are associated
with severe alveolar bone resorption20 (see Fig. 1). In some
patients, as the mandible resorbes down to basal bone the
mental foramen becomes involved in the denture bearing
area.21 The subsequent crushing of the emerging nerve by a
functioning lower denture can cause pain and discomfort.22
These patients may benefit from the use of a selective pressure
impression which reduces impression pressure in the area of
the mental foramen and ultimately reduces the pressure from
occlusal load under the subsequent denture in this area.
Experience at Leeds Dental Institute from an informal audit of
common clinical problems in complete denture patients had
suggested that the problem of the mental foramen on the
denture bearing area is under diagnosed.
The McGill consensus23 and York statement24 reflect the
current gold standard in the care of edentulous patients.
They state that the minimum acceptable standard of care for
the treatment of the edentulous mandible should be the
provision of Osseo-integrated dental implants to support and
retain the complete lower denture. This approach was fully

supported by the clinical team (with co-authorship to the York

statement). However, there are barriers to treatment with
implants; notably cost and surgical risk.25,26 Patients who have
a mental foramen within the denture bearing area, necessarily
have very little height to their mandible. This lack of bone
would usually indicate bone enhancement prior to implant
provision. Medical and social problems may contraindicate
autogenous bone transplants for many of the more frail older
patients. Others may refuse because they do not accept the
cost25 or surgical risk.26 This leaves a cohort of patients for
whom implant treatment is contraindicated or refused; in
these patients, conventional complete dentures remain the
best option for treatment.
If conventional dentures are to be provided; a traditional
way of relieving pressure over the mental foramen has been
advocated in the literature.27 The traditional method involves
placing a metallic foil on the working cast, over the area of the
mental foramen (Fig. 2). The placing of the foil provides space
under the finished lower denture. The space created is said to
provide local relief from pressure on occlusal loading of the
finished dentures.
This study investigated the effectiveness of a selective
pressure impression15 against the traditional clinical method
of re-distributing pressure27 and a control denture from a

Fig. 2 Traditional relief for the mental foramen obtained

by the use of metal foil spacers.

journal of dentistry 38 (2010) 853858

relatively mucostatic standard impression (placebo). The study

aimed to provide evidence of best practice, as indicated by
patient preference, for clinical impressions in the treatment of
patients with the problem of a prominent mental foramen.
The null hypothesis was that none of the dentures would
be preferred by the patients. The working hypothesis was that
one of the dentures would be preferred by the patients.

2.

Materials and methods

A sample size calculation based on the difference in proportions of preferring the selective impression technique compared to not preferring it, yielded a required sample size of 65.
Sixty-nine patients were recruited for the study. The trial was
conducted at Leeds Dental Institute, University of Leeds, UK.
Ethical approval was sought and obtained from the appropriate Medical Ethical Committee. All participants gave written,
signed, informed consent. Participants were recruited between November 2006 and November 2008 from the waiting
lists at the Institute. The last assessment (a three monthly
follow up OHIP questionnaire) was completed and the trial
finished in June 2009. The inclusion criteria were subjects who
are able to attend, were edentulous in the lower arch, and had
the mental foramen apparent clinically or radiographically on
the denture bearing area of the lower ridge. Exclusion criteria
were subjects who are allergic to acrylic or silicone rubber.
Immediately after a patient had consented to treatment and
before treatment commenced, the patient was asked to

855

complete an OHIP-1428 questionnaire to identify a baseline

for the secondary outcome measure of the impact of new
dentures on their quality of life.
The research team at Leeds has developed a method of
producing lower dentures that are very similar to each other
apart from a single pre-determined difference.29 For this crossover study, three very similar lower dentures were produced for
each patient. The clinician, dental nurse and the participants
were blind to the identity of the dentures. The first denture was
a control, constructed on a cast made form a standard, relatively
mucostatic, impression procedure. This standard impression
used a spaced acrylic custom tray and a medium bodied silicone
material (Express 3M) followed by a light bodied silicone wash
(Express 3M). The second denture was constructed by a
traditional method of dealing with problems of the mental
foramen. This traditional method used metal foils, placed over
the area of the mental foramina and processed the finished
denture on the spaced cast (Fig. 2). The foil used in this trial was
0.6 mm thick, manufactured by Minerva.
The third denture was constructed from a selective
pressure impression technique (the technique reported in
Hydes5 case history was adapted to relieve pressure over the
area of the mental foramen). The impression technique
incorporates altering the standard silicone impression by
cutting out the silicone from the area above the mental
foramen, perforating the impression tray in this area and
taking a light bodied silicone wash impression (Fig. 3).
The three dentures were given to each patient; the order in
which the dentures were assessed by the patient was

Fig. 3 A selective pressure impression in preparation. (Top left) The silicone in the area of the mental foramen is cut with a
scalpel and lifted out, (Top right) the acrylic custom impression tray is perforated in this area, (Bottom left) the tray is loaded
with light bodied silicone (Express 3M) and (Bottom right) the final impression.

856

journal of dentistry 38 (2010) 853858

determined by a blocked randomisation procedure. The order

the encoded dentures were to be worn was revealed on the day
of delivery of the first denture by a designated research nurse,
without the prior knowledge of the clinician. They wore each
denture for 1 week and assessed the denture individually.
When they had assessed each denture individually they were
given all three dentures together and asked to assess their
preferred denture over a period of 12 weeks. The stated
preference by the patient for a denture was the predetermined primary outcome measure for the study. All the
outcome assessments were performed by the patients; they
were recorded by the research nurse and the dentist remained
blind to the choice. After the patients had worn their preferred
denture for 3 months they were asked to complete a post
treatment OHIP-14 questionnaire to assess the impact of their
new dentures on their quality of life following treatment.
Multinomial logistic regression was used to analyse the
effect size and significance of possible confounding variables.
Subsequent analysis of patient preference was performed
using bootstrapped 95% confidence intervals.30

3.

Results

Sixty-six patients completed the trial (Fig. 4). Three patients

failed to complete; one deceased, one whose spouse deceased,
and one who was unable to continue because he required
unrelated surgery. The CONSORT flow diagram (Fig. 4) reports
the numbers in each arm of the trial.
The primary outcome measure was patient preference for
the denture. Thirty-three patients (50%) choose the denture
from the selective pressure impression; 19 (29%) choose the
denture from the traditional method of relieving pressure on
the mental foramen; and 14 (21%) preferred the control denture.
The possible confounding variables of age, sex, order of
delivery of the dentures, initial OHIP score, and final OHIP
score were investigated by multinomial logistic regression. No
evidence of a sizable or important effect of these potential

confounding variables was indicated. Therefore it was

considered unnecessary to adjust the model for these
variables. Consequently, bootstrapped 95% confidence intervals were preferred to the Null model and were used for
analysis. Bootstrapped 95% confidence intervals were used to
analyse patient preference for

1. the selective pressure method over the control;

2. the selective pressure over the traditional foil relief;
3. the traditional foil relief over the control.
The difference in preference for the selective pressure
method over the control method was 29% with a 95%
confidence interval of (9, 47)%. The difference in preference
for the selective pressure over the traditional foil method was
21% and of borderline significance with a 95% confidence
interval of ( 1, 47)%. The preference of the traditional method
over the control was not statistically significant.
When the participants wore the preferred denture for 3
months they reported an improved oral health related quality
of life via the OHIP questionnaire. The OHIP-14 score
decreased from 29 to 21.

4.

Discussion

The null hypothesis was that none of the dentures would be

preferred by the patients. The results of this study show 95%
confidence intervals indicating preference for the dentures
constructed from the selective pressure impression. The null
hypothesis is therefore rejected. In rejecting the null hypothesis, the alternative hypothesis is proposed that in this patient
group there was a preference for the denture made by the
selective pressure impression.
In addition to the statistical significance, it is important to
consider the clinical significance of these results. Patient
satisfaction is an important aim for complete denture

Fig. 4 CONSORT flow diagram for the cross-over Randomised Controlled Trial.

journal of dentistry 38 (2010) 853858

prosthodontics. The primary outcome of this trial, patient

preference, is closely related to patient opinion on satisfaction.
This trial presents results which show how a simple clinical
technique can significantly influence patient preference (and
related patient satisfaction) in a group of patients who have
been given a choice of three lower complete dentures. This
group of patients had difficult and multifaceted problems with
their lower dentures. It is clear that no single technique can be
the sole answer to these multifaceted problems. However, the
evidence for patient preference from this RCT is clear and
significant. Clinicians should consider adding this useful
impression technique to their prosthodontic repertoire. It is a
new technique for consideration when dealing with these
difficult clinical problems; the level of clinical evidence for the
impression technique from this RCT is strong.
The casts on which the three dentures were constructed
were labelled 1, 2 and 3 during the construction process. The
dentist constructing the dentures was initially blind to which
cast was which. Throughout the trial the dentist was not
informed which denture was which, but because the casts were
visibly different it was not possible to be certain the dentist
remained blind during the denture construction process of the
trial. This is a potential source of bias; this was anticipated and
safeguards put in place. The safeguards were threefold. Firstly,
the trial was designed so that the completed dentures were recoded and re-labelled (AC). Following this recoding, the dentist,
research nurse and patients remained blind to this coding of the
processed dentures. Secondly, the patients, who preformed all
the assessments, were blind throughout the trial. Thirdly, the
methodology used in this trial to produce very similar
dentures29 deliberately reduces the chance that potentially
biased actions by the dentist can affect denture shape. It is
therefore considered unlikely that intentional or unintentional
bias could have been introduced by the dentist constructing the
dentures.
The denture produced from the selective pressure technique5 is preferred in this study. It is reasonable to postulate
that the designed selective pressure of the impression
translates into preferential loading under the resultant
denture, and explains the patient preference for that denture.
This study provides evidence from an RCT of a preference for
a particular impression technique for complete dentures in this
patient group. The evidence is statistically and clinically
significant. This is the first Randomised Controlled Trial to
provide such evidence. Given the history and size of the
academic literature for impressions for complete dentures this
is remarkable. The failure of previous RCTs to produce a
positive outcome may be explained by the confounding
influence of the multitude of variables involved in denture
construction. Scientific methodology normally requires the
elimination or control of potential confounding variables. This
is a particular problem in prosthodontic research because of the
artistry of the discipline. In prosthodontic research the
application of the principles embodied in the scientific method
requires a particularly strict adherence to a disciplined protocol.
In the opinion of the authors there are three factors which have
been particularly important in providing a clear outcome for
this trial; firstly the methodology used in the duplication of the
shape and occlusion of the three trial dentures, secondly the
selection of a group of patients who all had a single specific

857

clinical condition and third, the use of a single operator. These

three factors reduced the confounding variables. Further, the
blocked random allocation process safeguards against any
unknown (or unexpected) confounding. The sample size was
sufficiently large to allow the detection of the difference that
exists within this sample. Finally in the opinion of the authors
the positive outcome of the trial was helped by the selection of
patient preference as the primary outcome. Patient preference
as an outcome measure was sufficiently sensitive and specific
in this study. Future RCTs in this area of study may benefit from
adopting similar strategies.

5.

Conclusions

It is concluded that this particular patient group had a

preference for the selective pressure impression technique.
This advocates the selective pressure impression technique and
provides dentists with good evidence for the clinical procedure.

Acknowledgment
This trial was funded by a grant from Dunhill Medical Trust.

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