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A Prospective Study On The Clinical Performance of Polysiloxane Soft Liners: One-Year Results
A Prospective Study On The Clinical Performance of Polysiloxane Soft Liners: One-Year Results
Original Paper
Mustafa Murat MUTLUAY1,2, Serra OGUZ3, Finn FLØYSTRAND1, Erik SAXEGAARD1, Arife DOGAN3, Bulent BEK4
and I. Eystein RUYTER2
1
Department of Prosthodontics, Faculty of Dentistry, University of Oslo
2
NIOM, Nordic Institute of Dental Materials, Haslum, Norway
3
Department of Prosthodontics, Faculty of Dentistry, Gazi University, Ankara, Turkey
4
Department of Prosthodontics, Faculty of Dentistry, Cumhuriyet University, Sivas, Turkey
Corresponding author, M. Murat MUTLUAY; E-mail: mmutluay@gmail.com
Objective: The aim of the present study was to evaluate the clinical performance of four denture soft liners up to 12
months. Materials and methods: Thirty-three edentulous patients who experienced difficulties when using hard denture
bases because of changes in denture-supporting tissues were accepted for the study and randomly received Molloplast
B, GC Reline Soft, Silagum Comfort, or Mollosil Plus relines. Performance of the materials was evaluated using nine
criteria at 3, 6, and 12 months: physical integrity, surface detail, adhesion, color, odor, plaque accumulation, resilience,
hygiene, and mucosal condition. A four-point categorized scale (1=poor, 2=fair, 3=good, 4=excellent) was used.
Unscheduled maintenance events and the presence of fungal colonization were also recorded. Results: The percentage of
patients available at 3, 6, and 12 months were 91%, 91%, and 66%. Main reasons for dropouts and discontinuation were
fractured dentures and patient dissatisfaction. At 6 months, 96% of the performance scores were good or excellent and
the largest changes were observed for physical integrity, surface detail, color, and fungal colonization. Fungal colonization
was the most commonly observed problem and was the only reason of failure at 12 months. Conclusions: The clinical
performance of all soft liners was slightly impaired over the 12-month observation. Except for cases showing extensive
fungal colonization, the observed changes in clinical performance did not necessitate remaking of the dentures. Mollosil
Plus showed a performance comparable to that of Molloplast B, and the other materials had slightly lower performance
especially in terms of fungal colonization.
cycle (Tables 1 and 2). Molloplast B is a heat- informed consent was obtained. The study protocol
cured, compression-molded material, and the other was reviewed and approved by the Human Ethics
soft liners are chairside relining materials which Committee at Gazi University’s Faculty of Medicine,
polymerize at room temperature. Ankara, Turkey.
manufacturers’ recommendations and a standardized running water. They were thus instructed because
curing cycle was used for processing the Molloplast this was the most commonly used method which did
relines. The denture was then delivered to the not require the patients to purchase any additional
patient and necessary adjustments were made at material. The instructions were repeated during
chair-side. every recall for a continuous level of motivation.
For chairside relining materials (n=8 for each
group), the dentures were ground on the tissue Data collection
contacting surface in order to obtain adequate space Patient demographics included gender, age, and
for the soft liner. This was done to a depth of 2 mm occupation (Table 3). Furthermore, patients’ health
as long as the denture thickness allowed. They were and medication usage, smoking history and their
coated with primer, relined with the soft liner, and oral hygiene practices were recorded. An intraoral
delivered to the patient at the same appointment examination was carried out, and the results were
according to the manufacturers’ instructions. entered in an examination form. A second form was
Blinding in this study was not possible because filled out during the visits where the condition of the
the different relining materials had very distinct liner was subjectively evaluated according to the nine
color differences. The clinicians had no previous primary criteria (Table 4): physical integrity, surface
experience with the proprietary materials used; this detail, adhesion, color, odor, plaque accumulation,
would reduce any bias introduced by familiarity with resilience, hygiene, mucosal condition of the patient
one of the products. occasionally, and signs of fungal colonization5).
Patients were instructed to clean the tissue Fungal colonization was recorded as P=present or
contacting surfaces of their dentures after every meal NP=not present; the other parameters were assigned
using liquid soap and a regular toothbrush under scores on a four-point categorized scale (Table 4).
Table 4 Criteria used for the evaluation of the liners and the scoring system used to record the condition of the liner
Mucosal condition evaluation 1-4 rating
Liner conditon evaluation 1) Physical integrity: Tearing loss of material
2) Surface detail: Loss of surface texture, roughening
3) Adhesion: Failure of the bond 1-4 rating
4) Color: Comparison with fresh unused material (1=poor, 2=fair,
5) Odor: Presence of any distinctive odor 3=good, 4=excellent
6) Plaque accumulation: Surface coverage with plaque
7) Hygiene: Surface coverage with food particles
8) Resilience: Comparison with fresh unused material P-NP rating
9) Fungal colonization: Presence of colonization (P=present, NP=not present)
DMJ 2008; 27(3): 440-447 443
Table 6 Some of the parameters followed during the study. The values show the distribution of scores for every material
type at each recall
3 months 6 months 12 months
Excellent
Excellent
Excellent
Good
Good
Good
Poor
Poor
Poor
Fair
Fair
Fair
n n n
MLP 0 0 2 7 9 0 0 2 7 9 0 0 2 5 7
GCS 0 0 5 2 7 0 0 5 2 7 1 0 1 1 3
Physical integrity SLC 0 0 3 5 8 0 0 3 5 8 0 1 2 4 7
MLS 1 0 0 5 6 1 1 1 3 6 0 1 1 3 5
MLP 0 0 0 9 9 0 0 2 7 9 0 0 2 5 7
GCS 0 1 1 5 7 0 2 0 5 7 1 0 1 1 3
Surface detail SLC 1 0 1 6 8 1 0 4 3 8 1 0 3 3 7
MLS 0 0 1 5 6 0 1 2 3 6 0 1 1 3 5
MLP 0 0 0 9 9 0 0 2 7 9 0 0 2 5 7
GCS 0 1 1 5 7 0 2 0 5 7 0 1 1 1 3
Adhesion to denture base SLC 1 0 1 6 8 1 0 4 3 8 1 0 3 3 7
MLS 0 0 1 5 6 0 1 2 3 6 0 1 1 3 5
MLP 0 0 4 5 9 0 1 5 3 9 0 1 3 2 7
GCS 0 0 2 5 7 0 0 3 4 7 0 0 2 1 3
Color stability SLC 0 0 3 5 8 0 1 3 4 8 0 1 3 3 7
MLS 0 0 1 5 6 0 1 2 3 6 0 1 1 3 5
444 DMJ 2008; 27(3): 440-447
Performance outcomes areas were limited in size and did not require any
Physical integrity: Average physical integrity score maintenance (Fig. 1).
of the materials changed after 3 months (Table 6). Surface detail: Scores given to visually assessed
The greatest decrease was with the GCS material changes in surface detail or deterioration in surface
where five of the seven dentures (71%) had problems texture, changed significantly after 3 and 6 months
related to physical integrity. This change was (p=0.008 for both). No significant differences were
significantly different from MLP which had changes found among the materials. The changes were
on only two dentures (22%) after 3 and 6 months often observed as roughening of the surface and
(p=0.049). No other significant differences were loss of shiny appearance ― which was first observed
observed among the materials. Of the 33 relined when the liner surface was cured against mucosa.
dentures, an average point of 3.5 was rated with Changes in surface detail were mostly observed in
the lowest score of 2 which was given to one denture the posterior area.
only, and for 13 dentures (39%) the score was still 4 Adhesion: Adhesion to denture base polymer was
after one year. The MLP material had more scores not significantly changed after 6 months compared
of 4 than the other materials. SLC also showed an to baseline, and no significant differences were
early decrease in physical integrity where three of found among the materials. 56% of the dentures
the samples had a decreased score after 3 months. still had the excellent score after 12 months, and
Failures were usually seen where the material was only three (9%) of the relines showed small failures
thin and not bonded to the denture base. These on the borders of the denture which did not require
Fig. 1 Clinical example of a MLP soft liner at 12 months’ Fig. 2 Clinical example of a GCS material at 12 months’
recall. Note the good condition of the liner in recall. Note the fungal colonization and problems
terms of physical integrity and surface detail as concerning physical integrity.
well as fungal colonization.
MLP 0 9 0 9 14 7
GCS 0 7 0 7 33 3
Failure because of
SLC 0 8 0 8 56 7
fungal c.
MLS 0 6 0 6 20 5
DMJ 2008; 27(3): 440-447 445
repeating the relining procedure (Fig. 1). practice may thus be limited.
Color change: Sixteen of the dentures (48%) were The percentages of patients available for follow-
rated one or two points lower at 3 months. Scores up were 91%, 91%, and 66% for 3, 6, and 12 months
at 3 and 6 months were significantly different from respectively. At 12 months, three of the patients did
baseline (p=0.014). No significant differences were not want to continue and three of the dropouts were
found among the materials. Fading of the material patients that could not be reached. The dropout rate
was uncommon, and the main reason for color change appeared to be moderate, considering the relatively
was staining. The typical staining color was yellow- high age of the patients.
brown, and this was patient-dependent rather than a Fatigue fracture of the denture base has
general finding. For three of the patients, an intense frequently been reported as the main reason for
color change was observed and the predominant discontinuing and this is ascribed to the decreased
color was brown. The average scores after 6 and 12 thickness of the denture5,14,15). In the present study,
months were 3.5 and 3.3 respectively. 15 percent of the dentures fractured within one year.
Plaque accumulation and hygiene: The amount Polysiloxanes are used in many biomaterial
of plaque found on the dentures, as well as hygiene, applications because of their stability and lack of
were assessed visually. The surfaces of all the toxicity. Although rarely reported and usually not
liners were partly covered with plaque, with very properly diagnosed, some adverse reactions to poly-
little variation among the patients. No significant siloxanes in different regions of the body have been
differences were found among the different materials reported15-17). One of the patients participating in our
(p>0.05). study showed a reaction to the polysiloxane soft liner
Resilience: Resilience of the materials was MLS after 24 hours of contact, resembling a type 1
assessed by comparing the liner to an unused sample, allergy to this material or to some other materials
and any detectable change was recorded. After 12 used during the chairside relining procedure. This
months, none of the soft liners showed any change patient wanted to withdraw from the study, and her
that could be detected by the clinician. denture was relined with a conventional denture
Condition of the mucosa: No indications of base polymer. A history of allergy was also recorded
change were observed after 3, 6, and 12 months, when this patient was first examined. Although no
except for one adverse reaction observed after 24 additional information was available for this patient,
hours. an allergic reaction was possible and this should be
Colonization of the soft liner surface: Fungal kept in mind during treatments.
colonization of the soft liner surface was observed at The term ‘physical integrity’ is related to the
3 months in two patients (6%). At 12 months, 36% general soundness and durability of the soft liner
of the dentures were affected with fungal colonization materials5). It may also reflect the durability of the
at different levels (Table 7, Fig. 2). For all the materials during cleaning procedures where brushing
time periods, SLC and GCS had a higher degree of or other means of cleaning subject the reline to
colonization than the others. At 12 months, seven various stresses. Failure is generally observed as
patients (21%) were recorded as failure because of tearing of the material and loss of parts of the reline
extensive colonization (Table 6). during clinical use. MLP showed slightly better
The largest differences among the materials performance at 12 months than the other materials
were observed for the colonization scores. At 12 and significantly better than GCS. The clinical
months, only one of the dentures relined with MLS significance of this finding was questionable because
showed visually detectable colonization and MLP the physical integrity problems were small. Failures
had colonization on only two of the dentures. At 6 were observed where the thickness of the soft liner
months, MLS was significantly different from GCS was less than adequate or not properly bonded to the
(p=0.03) and SLC (p=0.02). denture base.
A recent study by Oguz et al.18) published a
ranking of tensile strength and tear resistance of
DISCUSSION
MLP, GCS, and SLC. The results with and without
The survival of an oral restoration is affected thermocycling indicated that the tensile strength and
by operator-dependant factors, design factors, tear resistance results of MLP were not higher than
restoration material factors, intraoral location the others. The reason for performing better under
factors, and patient-related factors13). Operator clinical conditions might be the result of differences
factors are generally believed to be the most in the application procedure of the materials. The
important of these14). Our study was carried out in MLP material was cured in the laboratory using
a dental faculty environment by clinicians who are a conventional compression mold technique. As a
competent in the field of prosthodontics. Applicabil- result, it was possible to maintain an ideal thickness
ity of the clinical results to routine general dental and optimum physical conditions during curing.
446 DMJ 2008; 27(3): 440-447
The other materials (MLS, GCS, and SLC) might resilience remained optimal during the 12-month
have been negatively affected by less controllable period. These properties did not show any statistical
curing conditions during chairside application and changes compared to baseline and did not indicate
curing. The variable factors in terms of humidity, any failure related to material performance.
temperature, and pressure present during the Fungal colonization of the soft liner surface
curing of these materials could have caused poor was frequently observed in this study. Colonization
crosslinking and varying material thicknesses. started at 3 months for GCS and SLC and at 6
An intimate contact between a denture and months for MLP. Although the colonization of the
the supporting tissues is considered as one of the materials by oral fungi presents a problem regarding
key features of a successful removable denture. useful service life, no effects of such colonization on
Dentures must follow the contour and texture of the mucosal condition of the patients were observed.
the mucosa for both retention purpose and hygiene The lack of such a relation has been similarly
maintenance. The ability of a material to maintain reported in two published studies4,7). This lack of
this is important for long-term clinical success. The mucosal response to fungal colonization could be
materials used in our study showed changes in the explained by the fact that the patients chosen for
surface texture starting from the third month. This our study had no acute problems or no indications
type of degradation problem was frequently reported of denture stomatitis; they were generally healthy at
in previous publications4,5,8). MLP maintained the the beginning of the study22). Moreover, most of the
surface texture better than the other materials, dentures followed in our study were lower dentures,
which might be an indication of long-term success; and the inflammatory changes related to denture
however, this difference was not statistically stomatitis were reported to occur rarely under the
significant. This was comparable to a study where lower dentures23).
the dentures relined with MLP needed replacement In the present study, fungal colonization was
after 4-9 years of clinical service5). Degradation of assessed by visual inspection of the dentures. For
the materials resulting in changes in surface detail colonized micro-organisms to be visible, they would
and roughening was mostly observed in the posterior have formed a plaque of significant size. Colonization
region, which was probably a result of forces of of the soft liner surface begins with the initial
mastication affecting this region. adhesion of the micro-organisms24). For forming
Soft liners rely on good adhesion to the denture plaques or biofilms by cell division and agglutination,
base to function properly. Adhesion of polysiloxane surface roughness may be an important contributing
soft liners to denture base polymer has occasionally factor25-27). This was partly confirmed in our study,
been pronounced as the weak link19). In particular where visible colonization increased with changes
with the chairside polysiloxane soft liners, this has in surface detail (Tables 6 and 7). Changes in
been restated by many authors1,9,10,20,21). However, surface detail resulted in a very rough surface with
some studies also reported on long-term clinical many small cracks in the material, which thus
serviceability of the MLP material4,5,7,8). After one provided a larger surface area and a more protected
year of clinical service, the average score for the environment for colonization.
adhesion of soft liners to denture base polymer was The number of failures recorded in this study
still 3.9 for the current study. This result strongly suggested that fungal colonization of the materials,
suggested that the adhesion obtained by these probably a result of roughened soft liner surface, was
systems was durable enough to withstand clinical use the main reason for replacement (Fig, 2). However,
for one year. Failure was observed only marginally, this was not a general finding and was probably
and no relines required replacement after 12 months related to the patient’s oral conditions, which in this
of use. This was also supported by a previous study case included diet, saliva secretion, saliva quality,
which reported only slight edge failure of adhesion and efficiency of the cleaning procedures.
for MLP4). No indications of adhesion failure were
reported for dropouts.
CONCLUSIONS
The type of color change observed throughout
the study was staining of the materials rather than Within the confines of this clinical study, the
fading of the color. It did not affect the appearance following conclusions were drawn:
of the subject when using the denture. Three of 1. Among the chairside materials tested, MLS
the dentures showed heavy staining and these showed comparable performance to the
were related to smoking as expected. All the other compression-molded and heat-cured MLP,
dentures showed an acceptable resistance to staining followed by SLC and GCS. The easier/simpler
after one year. application procedure may thus render this
Other evaluation criteria such as plaque material as an alternative.
retention, oral hygiene, condition of the mucosa, and 2. After one year of clinical service, adhesion
DMJ 2008; 27(3): 440-447 447