Evaluation date: July 2002
Summary: High scores were achieved throughout the evaluation as well as a higher overall score for ease of use when compared to the pre-evaluation dentine bonding systems (4.6 to 4.2 on a visual analogue scale where 5.0 = easy to use and 1 = difficult to use). Despite not being told the cost of the product 8 evaluators (73%) stated that they would purchase Clearfil SE Bond and if priced competitively a further evaluator would
THE CLINICAL EVALUATION OF CLEARFIL SE BOND
BY THE PREP PANEL
F J T Burke & R J Crisp
Primary Dental Care Research Group
University of Birmingham School of Dentistry
St. Chad’s Queensway
Birmingham B4 6NN, UK
Tel 0121 237 2767
Fax 0121 237 2768
INTRODUCTION
Product :Clearfil SE Bond
Description:Dentine Bonding system
Manufacturer:Kuraray Co Ltd
Distributor:J & S Davies
Summit House
Potters Bar
Herts
EN6 3EE
Telephone:01707 822520
Fax:01707 646429
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INSTRUCTIONS TO EVALUATORS
Explanatory letters, questionnaires and packs of the Clearfil SE Bond, were distributed in March 2002. The practitioners were asked to use the materials and return the questionnaire. The questionnaire is reproduced in Appendix 1.
THE EVALUATORS
Eleven members of the PREP panel were selected at random for participation in this evaluation, two were female. The average time since graduation was 23 years, with a range of 9 to 34 years.
CLINICAL EVALUATION OF CLEARFIL SE BOND
BACKGROUND INFORMATION: REPLIES TO SECTION 1
All (100%) of the evaluators currently used a dentine bonding system. The systems used, and the number of users of each, were as follows:
System
/Number of users
Prime & Bond NT / 7Prompt- L / 4
Scotchbond / 3
Solo / 3
Admira / 2
Solid Bond / 2
Four evaluators (36%) used as many as three different systems. The principal reasons for the choice of these materials were good results and ease of use. Other reasons reported were good published data, no sensitivity, from reputable companies, and compatibility with the restorative material of choice.
The ease of use of the currently used bonding system was rated as follows:
Easy to useDifficult to use
4.2
51
The number of dentine bonded restorations placed by the evaluators in a typical week was as follows:
Number of restorationsNumber of respondents
<100
10-15 2
16-201
>208
EVALUATION OF CLEARFIL SE BOND
EVALUATION OF THE KIT AND MATERIAL AFTER FAMILIARISATION- REPLIES TO SECTION II.
Evaluators rated the presentation of the material as follows:
ExcellentPoor
4.8
5 1
One evaluator questioned the need for the second Bis-Gma bottle – “Are bond strengths and resin penetration improved by using this?”
The evaluators rated the laminated flow chart sheet as follows:
ExcellentPoor
4.7
5 1
One evaluator commented:
“It’s the business! – Very clear and well thought out”
The printed instructions were rated by the evaluators as follows:
ExcellentPoor
4.8
5 1
The majority of the evaluators (64% n=7) did use the dispenser case and 67% of those that tried it found it easy to use.
Comments made included:
“Excellent idea – worked well” (2)
“Difficult to fit bottles and close” (2)
“Nurse loved it”
“Found normal dispensing easier” (2)
Overall 5 evaluators (45%) stated that they found the dispenser case helpful.
EVALUATION OF CLEARFIL SE BOND IN CLINICAL USE: REPLIES TO SECTION III.
The total number of restorations placed during the evaluation was 967, comprised as follows:
Class I233
Class II146
Class III214
Class IV90
Class V284
When the evaluators were asked if Clearfil SE was used for other applications, 5 evaluators (45%) stated that they used the material for the pre-treatment of indirect restorations, 7 evaluators (64%) for the treatment of dentinal hypersensitivity and 3 evaluators (27%) for the repair of fractured porcelain. Other uses cited were for fissure sealants and to re-cement a fractured dentine bonded crown and core back onto the root surface.
All 100% of the evaluators who used the primer liquid dispenser stated that it worked satisfactorily.
Eight (73%) of the evaluators stated that the primer liquid was easily applied to the brush tip. The remainder made the following comments:
“Sponge applicators better – allow agitation and application into corners”
“Tended to lose some”
“Worked better on Unodent applicator tips then the nylon brushes”
91% (n=10) of the evaluators stated that the primer liquid was easily applied to the tooth surface. The other evaluator preferred the Unodent applicators.
Other comments made relating to the primer liquid were:
“Why not use disposable mini-brushes not handles plus brushes for easier infection control”
“Some practitioners may think it is not working as no frosting occurs – suggest that a colour change or some visual sign is needed” (2)
When the evaluators were asked to give their, and their DSA’s assessment of the dispensing and handling of the Clearfil SE Bond liquid, the result was as follows:
ConvenientInconvenient
4.8
5 1
When the evaluators were asked to rate the bonding liquid, the result was as follows:
Too viscous Too thin
3.1
5 1
All (100%) of the evaluators stated that the bonding liquid was easily applied to the tooth surface.
64% (n=7) of the evaluators stated that the primer did not give a ‘frosty’ appearance. Two (18%) evaluators stated that it did ‘frost’ and two evaluators did not answer this question.
91% (n=10) of the evaluators felt that it was an advantage of Clearfil SE, over other systems using phosphoric acid, in not having to wash off etching liquid. Comments made included:
“Brilliant”
“But need to explain the chemistry to practitioners to show difference over, say, Prompt L”
When the evaluators were asked to state how the application of Clearfil SE primer and bond liquids compared with the application of other resins previously used, the result was as follows:
Better9 (82%)Same1 (9%)Worse1 (9%)
No evaluators made a general statement regarding ‘messier ‘ or ‘less messier’ but the following comments were made:
“Just didn’t like the fiddly (2 bottle) system & not sure about etched appearance”
“Better than multi-stage systems but Prompt L less messy”
“We love the stuff & nothing has fallen out yet”
“Primer could still initiate bleeding if tissues less than ideal”
When the evaluators were asked if Clearfil SE Bond was Faster or Slower than the bonding system normally used, the result was as follows:
Faster6 (one answer qualified by “than Scotchbond & Prompt L”)
Slower6 (one answer qualified by “than Prime & Bond”)
All the evaluators (100%) stated that their dental nurses had no difficulties with Clearfil SE Bond.
8 of the evaluators (73%) stated that they would purchase the material at £X. Three evaluators wanted to know what X equalled!
Comments made by the evaluators when asked if there were any changes considered essential to the acceptability of Clearfil SE Bond included:
“Different coloured tops for the dispenser bottles fro ease of identification”
“Change the micro-brushes” (2)
“Explain the cost effectiveness of the material as many more restorations can be done than with Scotchbond and Prime & Bond”
When the evaluators were asked to rate the ease of use of Clearfil SE Bond, the result was as follows:
Easy to useDifficult to use
4.6
51
Final comments from the evaluators included:
“Fantastic product – couldn’t keep it in the surgery! Associates & partners used it as well & they did not record numbers so total number of restorations is really much higher. Makes fissure sealing easy. 5 Star!”
“ No post-operative sensitivity & appears to have high initial bond strength”
“Does it need Bis-Gma stage – why not incorporate with Stage 1”
“Excellent system with clear instructions. Easy for surgeon & nurse”
“Well presented material with accurate dispenser”
“Nurse still preferred squeezing bottle system”
“Brilliant – converted whole practice to this system”
“Prompt L and Prime & Bond launched as no-etch but now need etch. There is a need to convince practitioners this product is different – perhaps larger evidence based trials needed”
“Fantastic product – great results especially with Dyract”
“Good results & no recorded post-operative sensitivity. Any research to say even better with pre-etching?”
“Very popular with DSA & kind to patients. What is the bond strength?”
DISCUSSION AND CONCLUSIONS
The Clearfil SE Bond system has been subjected to an extensive evaluation, in clinical practice, by 11 members of the PREP panel in which 967 restorations were placed. Based on this the following conclusions may be made:
Presentation
The presentation of the material, the laminated flow chart and the printed instructions all scored highly (4.8, 4.7 and 4.8 respectively on a visual analogue scale where 5.0 = excellent and 1 = poor)
Delivery system
The majority of the evaluators did try the dispensing case and found it easy to use. However there appeared to be an approximately 50:50 split of opinion as to its benefit. Those evaluators and DSAs who liked it were strong in praise of its accuracy and ease of use but a roughly equal number preferred to self dispense the liquids. 91% of the evaluators stated that the primer liquid was easily applied to the tooth surface but one evaluator raised concerns re cross-infection control with the use handles + brushes, instead of wholly disposable mini-brushes.
The lack of a ‘frosted’ appearance was noted by 7 (64%) of the evaluators and comment was made by 2 evaluators that perhaps a visual indication that the material had ‘worked’ was needed. The lack of the need to wash off etchant was seen as a distinct advantage by 10 (91%) of the evaluators, though comment was made that the chemistry of Clearfil SE Bond should be explained in the light of changed recommendations regarding two other similar products initially launched as ‘no-etch’.
That the material was well received is indicated by the high scores achieved throughout the evaluation as well as a higher overall score for ease of use when compared to the pre-evaluation dentine bonding systems (4.6 to 4.2 on a visual analogue scale where 5.0 = easy to use and 1 = difficult to use). Despite not being told the cost of the product 8 evaluators (73%) stated that they would purchase Clearfil SE Bond and if priced competitively a further evaluator would purchase.