A Prospective Study on the Clinical Performance of Polysiloxane Soft

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bases because of changes in denture-supporting tissues were accepted for the study and randomly received Molloplast. B, GC Reline Soft, Silagum Comfort, ...
Dental Materials Journal 2008; 27(3): 440-447 Original Paper

   

A Prospective Study on the Clinical Performance of Polysiloxane Soft Liners: One-year Results    

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 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:  [email protected] 2

   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. Key words:  Polysiloxane, Removable denture, Fungal colonization   

INTRODUCTION For  patients  who  cannot  tolerate  a  hard  denture  base,  soft  liners  are  an  important  adjunct  treatment  to  help  the  patients  adapt  to  their  new  dentures1).   A  recent  report  indicated  that  some  75%  of  patients  needed  relining  of  the  implant-supported  overdentures  after  an  average  of  7.8  months,  and  soft  liners  were  often  favored  as  an  alternative  to  conventional hard relining materials2).   Use  of  soft  lining  materials  was  previously  considered  as  a  temporary  measure3).    However,  several  authors  have  reported  on  a  long  service  life  of  soft  liners,  sometimes  remaining  on  the  denture  for its full service life4-8).   A  soft  liner’s    assessment  criteria  as  listed   by  many  authors  were,  namely,  resilience,  tear  resistance,  biocompatibility,  lack  of  odor  and  taste,  adhesive bond strength, color stability, and resistance  to  abrasion9-11).    Although  some  of  the  material  types  were reported to maintain these qualities for a longer  time than the others, loss of bonding to denture base  polymers  and  fungal  colonization  on  and  within  the 

Received Sep 18, 2007: Accepted Dec 19, 2007

soft liners continue to be the main problems limiting  their use9-11).   In  the  last  decade,  soft  liners  have  been  improved and new materials have become available12).   However,  there  are  few  published  studies  which  effectively  test  the  clinical  performance  of  these   liners  and  provide  documentation  about  their   serviceability.   The  specific  aim  of  this  study  was  to  assess  the  clinical  performance  of  three  recently  introduced  materials  with  relatively  new  formulations  and  application  methods,  and  to  compare  their  clinical  performance with that of a well-studied, conventional  material serving as a control. MATERIALS  AND  METHODS Soft liner materials The  materials  used  in  this  study  were,  Molloplast  B,  GC  Reline  Soft,  Silagum  Comfort,  and  Mollosil  Plus  (Table  1).    All  the  four  materials  are  based  on  polysiloxanes.    They  differ  mainly  in  terms  of  application  technique,  polymerization,  and/or  curing 

DMJ 2008; 27(3): 440-447

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cycle  (Tables  1  and  2).    Molloplast  B  is  a  heatcured,  compression-molded  material,  and  the  other  soft  liners  are  chairside  relining  materials  which  polymerize at room temperature.

informed  consent  was  obtained.    The  study  protocol  was  reviewed  and  approved  by  the  Human  Ethics  Committee  at  Gazi  University’s  Faculty  of  Medicine,  Ankara, Turkey.

Study population Subjects  accepted  for  this  study  were  edentulous  male (15) and female (18) patients (median age for all  patients  was  65  years)  who  came  to  the  prosthodontics clinic at Faculty of Dentistry, Gazi University in  Ankara,  Turkey,  with  complaints  relevant  to  clinical  indications  for  a  soft  liner  therapy.    These  problems  arose  from  changes  in  the  denture-bearing  hard  and  soft tissues, i.e., alveolar resorption or poor quality of  the  denture-bearing  mucosa1).    Patients  who  needed  local  relief  of  pressure  for  wound  healing  following  a  surgical  intervention  or  patients  with  other  acute  problems  were  not  included  in  this  study,  since  such  indications usually require only short-term use of the  material limited to a few months.  The distribution of  the patients is given in Table 3.   Subjects  were  accepted  for  this  study  after  their 

Treatment protocol During the first appointment, a detailed examination  form  was  filled  out  and  the  oral  condition  of  the  patient was recorded.   Subjects  were  distributed  according  to  a  randomly  generated  treatment  allocation  to  four  soft  liner groups and received the liners accordingly.  For  the  Molloplast  B  group  (n=9),  the  tissue  surface  of  the  patient’s  denture  was  ground  to  obtain  the  necessary  space  required.    A  thickness  of  2-3  mm  was  aimed  at,  but  because  of  anatomical  variations  and variations among the different patients’ dentures,  this  was  not  always  achieved.    Consequently,  the  dentures  were  border-molded  and  an  impression  was  taken  with  a  eugenol-free  impression  paste  (Cavex  Outline,  Cavex,  Holland).    At  the  laboratory,  the  recommended  primer  was  applied  as  per  the 

Table 1 

Materials used for the study

Brand names (Code)

Manufacturer

Processing method

Molloplast B (MLP)

Detax GmbH, Ettlingen, Germany

Heat-cure

Primo adhesive

Detax GmbH, Ettlingen, Germany

Recommended  for  Molloplast  B.  Apply  and  let dry for 60-90 min.

GC Reline Soft (GCS)

GC Co, Tokyo, Japan

Autopolymerizing

GC Reline Primer R 

GC Co, Tokyo, Japan

Recommended  for  GC  Reline  soft.  Apply  to  the surface and gently dry with air.

Silagum Comfort (SLC)

DMG, Hamburg, Germany

Autopolymerizing

Silagum Comfort Primer 

DMG, Hamburg, Germany

Recommended  for  Silagum  AM  Comfort.  Apply and let solvent dry for 1 min.

Mollosil plus (MLS)

Detax GmbH, Ettlingen, Germany

Autopolymerizing

Mollosil plus Primer

Detax GmbH, Ettlingen, Germany

Recommended  for  Mollosil  plus.  Apply  and  let solvent dry for one minute

Table 2 

Chemical ingredients of the materials according to manufacturers’ information

Material

Components

Primer

MLP 

Condensation polysiloxane material, PMMA, γ-methacryloyloxypropyltrimethoxysilane

Mixture of methoxy and ethoxy silane derivatives

GCS

Silicon dioxide, Vinyl dimethyl polysiloxane, Hydrogen polysiloxane

SLC

Vinyl polysiloxane, Hydrogen polysiloxane, aerosil, additives

MLS

Polydimethylsiloxane with functional groups, filler, pigments, platinum catalyst PMMA=Poly (methyl methacrylate)

Ethyl acetate >90% Ethyl acetate, modified polyacrylate, additives Ethyl acetate 60-100%

442

DMJ 2008; 27(3): 440-447

manufacturers’ recommendations and a standardized  curing  cycle  was  used  for  processing  the  Molloplast  relines.    The  denture  was  then  delivered  to  the  patient  and  necessary  adjustments  were  made  at  chair-side.   For  chairside  relining  materials  (n=8  for  each  group),  the  dentures  were  ground  on  the  tissue  contacting  surface  in  order  to  obtain  adequate  space  for the soft liner.  This was done to a depth of 2 mm  as long as the denture thickness allowed.  They were  coated  with  primer,  relined  with  the  soft  liner,  and  delivered  to  the  patient  at  the  same  appointment  according to the manufacturers’ instructions.   Blinding  in  this  study  was  not  possible  because  the  different  relining  materials  had  very  distinct  color  differences.    The  clinicians  had  no  previous  experience  with  the  proprietary  materials  used;  this  would reduce any bias introduced by familiarity with  one of the products.   Patients  were  instructed  to  clean  the  tissue  contacting surfaces of their dentures after every meal  using  liquid  soap  and  a  regular  toothbrush  under  Table 3 

running  water.    They  were  thus  instructed  because  this  was  the  most  commonly  used  method  which  did  not  require  the  patients  to  purchase  any  additional  material.    The  instructions  were  repeated  during  every recall for a continuous level of motivation. Data collection Patient  demographics  included  gender,  age,  and  occupation  (Table  3).    Furthermore,  patients’  health  and  medication  usage,  smoking  history  and  their  oral  hygiene  practices  were  recorded.    An  intraoral  examination  was  carried  out,  and  the  results  were  entered in an examination form.  A second form was  filled out during the visits where the condition of the  liner was subjectively evaluated according to the nine  primary criteria (Table 4): physical integrity, surface  detail,  adhesion,  color,  odor,  plaque  accumulation,  resilience,  hygiene,  mucosal  condition  of  the  patient  occasionally,  and  signs  of  fungal  colonization5).   Fungal  colonization  was  recorded  as  P=present  or  NP=not present; the other parameters were assigned  scores  on  a  four-point  categorized  scale  (Table  4).  

Data collected during the study

Demographics

Gender distribution Age distribution (mean=65.5)

History

Smoking habits Medication usage

Denture hygiene practices before  the study

Denture Table 4 

Upper Lower

Male Female 40-49 50-59 60-69 >70

15 18  2  9  9 13

Smoking Non-smoking Using at least one medication regularly Not on medication Toothbrush and toothpaste Toothbrush and soap Soap only Immersing into NaOCI Cleaning tablets

 3 30 14 19  2  7 19  2  3  4 29

Criteria used for the evaluation of the liners and the scoring system used to record the condition of the liner

Mucosal condition evaluation Liner conditon evaluation

1-4 rating 1)  Physical integrity: Tearing loss of material 2)  Surface detail: Loss of surface texture, roughening 3)  Adhesion: Failure of the bond 4)  Color: Comparison with fresh unused material 5)  Odor: Presence of any distinctive odor

1-4 rating (1=poor, 2=fair,  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 9)  Fungal colonization: Presence of colonization

P-NP rating (P=present, NP=not present)

443

DMJ 2008; 27(3): 440-447 The worst site where the most obvious changes were  observed was also recorded where applicable.   Patients  were  recalled  at  3,  6,  and  12  months  for  an  evaluation  of  the  liner,  and  unscheduled  maintenance  events  were  also  recorded.    Dropouts  from  the  study  population  were  also  categorized  and  recorded at the time of the event either as patient not  satisfied,  patient  lost  to  follow-up,  adverse  reaction,  or fracture of denture.

RESULTS Overall performance The  recall  rate  at  3,  6,  and  12  months  were  91%,  91%,  and  66%.    Table  5  lists  the  dropouts  and  discontinuers.    The  reason  for  discontinuing  was  severe  fractures which required remaking or rebasing of the  dentures.    Five  lower  dentures  (15%)  had  fractured  between baseline and 12 months.   The  main  reason  for  dropout  was  patient  dissatisfaction with the denture.  Only one adverse reaction  was  recorded  during  the  study:  a  female  patient  using  the  MLS  reported  a  burning  sensation  on  the  mucosa and generalized redness was observed.   Among  the  followed  relines,  four  were  on  upper  dentures.    Two  of  these  patients  were  lost  to  follow-up  at  6  and  12  months.    Therefore,  a  proper  statistical  analysis  was  not  possible.    Nonetheless,  no  recognizable  differences  were  observed  between  upper  and  lower  dentures  in  terms  of  material  performance.

Statistical analysis Collected data were analyzed using a SPSS statistical  package  (version  14.0).    The  outcomes  were  changes  in  primary  end-points  and  fungal  colonization.    A  comparison  of  the  material  performance  over  time  and  among  the  material  types  was  done  by  chisquare  and  Wilcoxon  signed  rank  tests.    The  12month  controls  had  too  much  lost  data.    Therefore,  the main statistical analysis was carried out on data  obtained from the 3 and 6-months controls.

Table 5 

Dropouts and discontinued patients and reasons 3 months

6 months

12 months

MLP 0 0 2d,d a GCS 1 0 4b,b,d,d SLC 0 0 1a MLS 2a,c 0 1d Superscript  letters  show  the  reasons  for  dropouts  and  discontinuers:  a patient  not  satisfied,  b lost  to  follow  up,  c adverse  reaction, and discontinued patients  d severe fracture of denture requiring new prosthesis. Table 6 

Some of the parameters followed during the study.  The values show the distribution of scores for every material  type at each recall

Good

Excellent

n

Poor

Fair

Good

Excellent

n

Poor

Fair

Good

Excellent

12 months

Fair

6 months

Poor

3 months

n

Physical integrity

MLP GCS SLC MLS

0 0 0 1

0 0 0 0

2 5 3 0

7 2 5 5

9 7 8 6

0 0 0 1

0 0 0 1

2 5 3 1

7 2 5 3

9 7 8 6

0 1 0 0

0 0 1 1

2 1 2 1

5 1 4 3

7 3 7 5

Surface detail

MLP GCS SLC MLS

0 0 1 0

0 1 0 0

0 1 1 1

9 5 6 5

9 7 8 6

0 0 1 0

0 2 0 1

2 0 4 2

7 5 3 3

9 7 8 6

0 1 1 0

0 0 0 1

2 1 3 1

5 1 3 3

7 3 7 5

Adhesion to denture base

MLP GCS SLC MLS

0 0 1 0

0 1 0 0

0 1 1 1

9 5 6 5

9 7 8 6

0 0 1 0

0 2 0 1

2 0 4 2

7 5 3 3

9 7 8 6

0 0 1 0

0 1 0 1

2 1 3 1

5 1 3 3

7 3 7 5

Color stability

MLP GCS SLC MLS

0 0 0 0

0 0 0 0

4 2 3 1

5 5 5 5

9 7 8 6

0 0 0 0

1 0 1 1

5 3 3 2

3 4 4 3

9 7 8 6

0 0 0 0

1 0 1 1

3 2 3 1

2 1 3 3

7 3 7 5

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DMJ 2008; 27(3): 440-447

Performance outcomes Physical integrity:  Average  physical  integrity  score  of  the  materials  changed  after  3  months  (Table  6).   The  greatest  decrease  was  with  the  GCS  material  where five of the seven dentures (71%) had problems  related  to  physical  integrity.    This  change  was  significantly  different  from  MLP  which  had  changes  on  only  two  dentures  (22%)  after  3  and  6  months  (p=0.049).    No  other  significant  differences  were  observed  among  the  materials.    Of  the  33  relined  dentures,  an  average  point  of  3.5  was  rated  with  the lowest score of 2 which was given to one denture  only, and for 13 dentures (39%) the score was still 4  after  one  year.    The  MLP  material  had  more  scores  of  4  than  the  other  materials.    SLC  also  showed  an  early  decrease  in  physical  integrity  where  three  of  the  samples  had  a  decreased  score  after  3  months.   Failures  were  usually  seen  where  the  material  was  thin  and  not  bonded  to  the  denture  base.    These 

areas  were  limited  in  size  and  did  not  require  any  maintenance (Fig. 1).   Surface detail:  Scores  given  to  visually  assessed  changes  in  surface  detail  or  deterioration  in  surface  texture,  changed  significantly  after  3  and  6  months  (p=0.008  for  both).    No  significant  differences  were  found  among  the  materials.    The  changes  were  often  observed  as  roughening  of  the  surface  and  loss  of  shiny  appearance ― which  was  first  observed  when  the  liner  surface  was  cured  against  mucosa.   Changes  in  surface  detail  were  mostly  observed  in  the posterior area.   Adhesion: Adhesion to denture base polymer was  not  significantly  changed  after  6  months  compared  to  baseline,  and  no  significant  differences  were  found  among  the  materials.    56%  of  the  dentures  still  had  the  excellent  score  after  12  months,  and  only  three  (9%)  of  the  relines  showed  small  failures  on  the  borders  of  the  denture  which  did  not  require 

Fig. 1 

Fig. 2 

Table 7 

Clinical example of a MLP soft liner at 12 months’  recall.    Note  the  good  condition  of  the  liner  in  terms  of  physical  integrity  and  surface  detail  as  well as fungal colonization.

Clinical  example  of  a  GCS  material  at  12  months’  recall.    Note  the  fungal  colonization  and  problems  concerning physical integrity.

Percentages of soft liners with fungal colonization and failures 3 months

Fungal colonization

Failure because of  fungal c.

6 months

12 months

(+)

n

(+)

n

(+)

n

MLP

 0

9

22

9

14

7

GCS

13

7

30

7

66

3

SLC

13

8

75

8

83

7

MLS

 0

6

 0

6

20

5

MLP

 0

9

 0

9

14

7

GCS

 0

7

 0

7

33

3

SLC

 0

8

 0

8

56

7

MLS

 0

6

 0

6

20

5

DMJ 2008; 27(3): 440-447 repeating the relining procedure (Fig. 1).   Color change: Sixteen of the dentures (48%) were  rated  one  or  two  points  lower  at  3  months.    Scores  at  3  and  6  months  were  significantly  different  from  baseline  (p=0.014).    No  significant  differences  were  found  among  the  materials.    Fading  of  the  material  was uncommon, and the main reason for color change  was  staining.    The  typical  staining  color  was  yellowbrown, and this was patient-dependent rather than a  general finding.  For three of the patients, an intense  color  change  was  observed  and  the  predominant  color  was  brown.    The  average  scores  after  6  and  12  months were 3.5 and 3.3 respectively.   Plaque accumulation and hygiene:  The  amount  of  plaque  found  on  the  dentures,  as  well  as  hygiene,  were  assessed  visually.    The  surfaces  of  all  the  liners  were  partly  covered  with  plaque,  with  very  little  variation  among  the  patients.    No  significant  differences were found among the different materials  (p>0.05).   Resilience:  Resilience  of  the  materials  was  assessed by comparing the liner to an unused sample,  and  any  detectable  change  was  recorded.    After  12  months,  none  of  the  soft  liners  showed  any  change  that could be detected by the clinician.   Condition of the mucosa:  No  indications  of  change  were  observed  after  3,  6,  and  12  months,  except  for  one  adverse  reaction  observed  after  24  hours.    Colonization of the soft liner surface:  Fungal  colonization  of  the  soft  liner  surface  was  observed  at  3  months  in  two  patients  (6%).    At  12  months,  36%  of the dentures were affected with fungal colonization  at  different  levels  (Table  7,  Fig.  2).    For  all  the  time  periods,  SLC  and  GCS  had  a  higher  degree  of  colonization  than  the  others.    At  12  months,  seven  patients  (21%)  were  recorded  as  failure  because  of  extensive colonization (Table 6).   The  largest  differences  among  the  materials  were  observed  for  the  colonization  scores.    At  12  months,  only  one  of  the  dentures  relined  with  MLS  showed  visually  detectable  colonization  and  MLP  had  colonization  on  only  two  of  the  dentures.    At  6  months,  MLS  was  significantly  different  from  GCS  (p=0.03) and SLC (p=0.02). DISCUSSION The  survival  of  an  oral  restoration  is  affected  by  operator-dependant  factors,  design  factors,  restoration  material  factors,  intraoral  location  factors,  and  patient-related  factors13).    Operator  factors  are  generally  believed  to  be  the  most  important  of  these14).    Our  study  was  carried  out  in  a  dental  faculty  environment  by  clinicians  who  are  competent  in  the  field  of  prosthodontics.    Applicability  of  the  clinical  results  to  routine  general  dental 

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practice may thus be limited.   The  percentages  of  patients  available  for  followup were 91%, 91%, and 66% for 3, 6, and 12 months  respectively.  At 12 months, three of the patients did  not  want  to  continue  and  three  of  the  dropouts  were  patients that could not be reached.  The dropout rate  appeared  to  be  moderate,  considering  the  relatively  high age of the patients.    Fatigue  fracture  of  the  denture  base  has  frequently  been  reported  as  the  main  reason  for  discontinuing  and  this  is  ascribed  to  the  decreased  thickness  of  the  denture5,14,15).    In  the  present  study,  15 percent of the dentures fractured within one year.   Polysiloxanes  are  used  in  many  biomaterial  applications  because  of  their  stability  and  lack  of  toxicity.    Although  rarely  reported  and  usually  not  properly  diagnosed,  some  adverse  reactions  to  polysiloxanes  in  different  regions  of  the  body  have  been  reported15-17).  One of the patients participating in our  study showed a reaction to the polysiloxane soft liner  MLS  after  24  hours  of  contact,  resembling  a  type  1  allergy  to  this  material  or  to  some  other  materials  used  during  the  chairside  relining  procedure.    This  patient  wanted  to  withdraw  from  the  study,  and  her  denture  was  relined  with  a  conventional  denture  base polymer.  A history of allergy was also recorded  when  this  patient  was  first  examined.    Although  no  additional information was available for this patient,  an  allergic  reaction  was  possible  and  this  should  be  kept in mind during treatments.   The  term  ‘physical  integrity’  is  related  to  the  general  soundness  and  durability  of  the  soft  liner  materials5).    It  may  also  reflect  the  durability  of  the  materials during cleaning procedures where brushing  or  other  means  of  cleaning  subject  the  reline  to  various  stresses.    Failure  is  generally  observed  as  tearing of the material and loss of parts of the reline  during  clinical  use.    MLP  showed  slightly  better  performance  at  12  months  than  the  other  materials  and  significantly  better  than  GCS.    The  clinical  significance  of  this  finding  was  questionable  because  the physical integrity problems were small.  Failures  were  observed  where  the  thickness  of  the  soft  liner  was less than adequate or not properly bonded to the  denture base.   A  recent  study  by  Oguz  et al.18)  published  a  ranking  of  tensile  strength  and  tear  resistance  of  MLP,  GCS,  and  SLC.    The  results  with  and  without  thermocycling indicated that the tensile strength and  tear  resistance  results  of  MLP  were  not  higher  than  the  others.    The  reason  for  performing  better  under  clinical  conditions  might  be  the  result  of  differences  in  the  application  procedure  of  the  materials.    The  MLP  material  was  cured  in  the  laboratory  using  a  conventional  compression  mold  technique.    As  a  result, it was possible to maintain an ideal thickness  and  optimum  physical  conditions  during  curing.  

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The  other  materials  (MLS,  GCS,  and  SLC)  might  have  been  negatively  affected  by  less  controllable  curing  conditions  during  chairside  application  and  curing.    The  variable  factors  in  terms  of  humidity,  temperature,  and  pressure  present  during  the  curing  of  these  materials  could  have  caused  poor  crosslinking and varying material thicknesses.   An  intimate  contact  between  a  denture  and  the  supporting  tissues  is  considered  as  one  of  the  key  features  of  a  successful  removable  denture.   Dentures  must  follow  the  contour  and  texture  of  the  mucosa  for  both  retention  purpose  and  hygiene  maintenance.    The  ability  of  a  material  to  maintain  this  is  important  for  long-term  clinical  success.    The  materials  used  in  our  study  showed  changes  in  the  surface  texture  starting  from  the  third  month.    This  type  of  degradation  problem  was  frequently  reported  in  previous  publications4,5,8).    MLP  maintained  the  surface  texture  better  than  the  other  materials,  which  might  be  an  indication  of  long-term  success;  however,  this  difference  was  not  statistically  significant.    This  was  comparable  to  a  study  where  the  dentures  relined  with  MLP  needed  replacement  after  4-9  years  of  clinical  service5).    Degradation  of  the  materials  resulting  in  changes  in  surface  detail  and roughening was mostly observed in the posterior  region,  which  was  probably  a  result  of  forces  of  mastication affecting this region.   Soft  liners  rely  on  good  adhesion  to  the  denture  base  to  function  properly.    Adhesion  of  polysiloxane  soft  liners  to  denture  base  polymer  has  occasionally  been  pronounced  as  the  weak  link19).    In  particular  with  the  chairside  polysiloxane  soft  liners,  this  has  been  restated  by  many  authors1,9,10,20,21).    However,   some  studies  also  reported  on  long-term  clinical   serviceability  of  the  MLP  material4,5,7,8).    After  one  year  of  clinical  service,  the  average  score  for  the  adhesion  of  soft  liners  to  denture  base  polymer  was  still  3.9  for  the  current  study.    This  result  strongly  suggested  that  the  adhesion  obtained  by  these  systems was durable enough to withstand clinical use  for  one  year.    Failure  was  observed  only  marginally,  and no relines required replacement after 12 months  of  use.    This  was  also  supported  by  a  previous  study  which  reported  only  slight  edge  failure  of  adhesion  for  MLP4).    No  indications  of  adhesion  failure  were  reported for dropouts.   The  type  of  color  change  observed  throughout  the  study  was  staining  of  the  materials  rather  than  fading  of  the  color.    It  did  not  affect  the  appearance  of  the  subject  when  using  the  denture.    Three  of  the  dentures  showed  heavy  staining  and  these  were  related  to  smoking  as  expected.    All  the  other  dentures showed an acceptable resistance to staining  after one year.   Other  evaluation  criteria  such  as  plaque  retention,  oral  hygiene,  condition  of  the  mucosa,  and 

resilience  remained  optimal  during  the  12-month  period.  These properties did not show any statistical  changes  compared  to  baseline  and  did  not  indicate  any failure related to material performance.   Fungal  colonization  of  the  soft  liner  surface  was  frequently  observed  in  this  study.    Colonization  started  at  3  months  for  GCS  and  SLC  and  at  6  months  for  MLP.    Although  the  colonization  of  the  materials by oral fungi presents a problem regarding  useful  service  life,  no  effects  of  such  colonization  on  the  mucosal  condition  of  the  patients  were  observed.   The  lack  of  such  a  relation  has  been  similarly  reported  in  two  published  studies4,7).    This  lack  of  mucosal  response  to  fungal  colonization  could  be  explained  by  the  fact  that  the  patients  chosen  for  our  study  had  no  acute  problems  or  no  indications  of denture stomatitis; they were generally healthy at  the  beginning  of  the  study22).    Moreover,  most  of  the  dentures  followed  in  our  study  were  lower  dentures,  and  the  inflammatory  changes  related  to  denture  stomatitis  were  reported  to  occur  rarely  under  the  lower dentures23).   In  the  present  study,  fungal  colonization  was  assessed  by  visual  inspection  of  the  dentures.  For  colonized  micro-organisms  to  be  visible,  they  would  have formed a plaque of significant size.  Colonization  of  the  soft  liner  surface  begins  with  the  initial  adhesion  of  the  micro-organisms24).    For  forming  plaques or biofilms by cell division and agglutination,  surface  roughness  may  be  an  important  contributing  factor25-27).    This  was  partly  confirmed  in  our  study,  where  visible  colonization  increased  with  changes  in  surface  detail  (Tables  6  and  7).    Changes  in  surface  detail  resulted  in  a  very  rough  surface  with  many  small  cracks  in  the  material,  which  thus  provided  a  larger  surface  area  and  a  more  protected  environment for colonization.   The  number  of  failures  recorded  in  this  study  suggested  that  fungal  colonization  of  the  materials,  probably a result of roughened soft liner surface, was  the  main  reason  for  replacement  (Fig,  2).    However,  this  was  not  a  general  finding  and  was  probably  related  to  the  patient’s  oral  conditions,  which  in  this  case  included  diet,  saliva  secretion,  saliva  quality,  and efficiency of the cleaning procedures. CONCLUSIONS Within  the  confines  of  this  clinical  study,  the  following conclusions were drawn: 1.  Among  the  chairside  materials  tested,  MLS  showed  comparable  performance  to  the  compression-molded  and  heat-cured  MLP,  followed by SLC and GCS.  The easier/simpler  application  procedure  may  thus  render  this  material as an alternative. 2.  After  one  year  of  clinical  service,  adhesion 

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3.  4. 

5.  6. 

failure  was  observed  only  marginally  and  no  relines  required  replacement  because  of  adhesion problem. After  one  year,  SLC  and  GCS  showed  fungal  colonization  sooner  and  more  extensively  than  the other materials. Reducing  fungal  colonization  on  the  surface  and  improving  mechanical  strength  may  further  improve  the  clinical  performance  of  soft liners. For all the investigated liners, the results were  good  or  excellent  for  majority  of  the  patients  after six months of clinical use. For  early  detection  of  fungal  colonisation,  every patient with a relined denture should be  called back after three months of use. ACKNOWLEDGEMENTS

The  authors  wish  to  express  their  gratitude  to  Professor  Leiv  Sandvik  for  statistical  advice.    We  also  thank  Professor  Dag  Ørstavik  and  Professor  Timo  Närhi  for  helpful  discussions  and  valuable  suggestions during the preparation of the manuscript.   The  materials  were  in  part  supplied  by  the   manufacturers, and this was also much appreciated. REFERENCES 1)  Mack  PJ.    Denture  soft  lining  materials:  clinical  indications.  Aust Dent J 1989; 34: 454-458. 2)  Attard  NJ,  David  LA,  Zarb  GA.    Immediate  loading  of  implants  with  mandibular  overdentures:  Oneyear  clinical  results  of  a  prospective  study.    Int  J  Prosthodont 2005;18: 463-470. 3)  Wright  PS.    Soft  lining  materials:  their  status  and  prospects.  J Dent 1976; 4: 247-256. 4)  Wright  PS.    The  success  and  failure  of  denture   soft-lining  materials  in  clinical  use.    J  Dent  1984;  12: 319-327. 5)  Wright  PS.    Observations  on  long-term  use  of  a   soft-lining  material  for  mandibular  complete  dentures.  J Prosthet Dent 1994; 72: 385-392. 6)  Schmidt WF, Jr., Smith DE.  A six-year retrospective  study of Molloplast-B-lined dentures.  Part I: Patient  response.  J Prosthet Dent 1983; 50: 308-313. 7)  Schmidt WF, Jr., Smith DE.  A six-year retrospective  study  of  Molloplast-B-lined  dentures.    Part  II:  Liner  serviceability.  J Prosthet Dent 1983;50: 459-465. 8)  Jepson  NJ,  McCabe  JF,  Storer  R.    The  clinical  serviceability of two permanent denture soft linings.   Br Dent J 1994; 177: 11-16. 9)  Braden  M,  Wright  PS,  Parker  S.    Soft  lining   materials ― a  review.    Eur  J  Prosthodont  Restor  Dent 1995; 3: 163-174. 10)  Braden  M.    Polymeric  Dental  Materials,  SpringerVerlag, Berlin, 1997, pp.125-137. 11)  Garcia  LT,  Jones  JD.    Soft  liners.    Dent  Clin  North 

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