The Clinical Evaluation of Xeno Iii

Evaluation date: October 2002

Summary: The positive reception of this bonding material is underlined by the fact that the majority of the evaluators (67%) would purchase the material if available at average cost and if some of the changes as suggested by the evaluators were implemented this figure would further improve.

THE CLINICAL EVALUATION OF XENO III

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

Email

INTRODUCTION

Product:Xeno III

Description:Dentine Bonding system

Manufacturer:Dentsply Ltd

Hamm Moor Lane

Weybridge

Surrey KT15 2SE

Telephone:01932 853422

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INSTRUCTIONS TO EVALUATORS

Explanatory letters, questionnaires and packs of Xeno III, were distributed in September 2002. The practitioners were asked to use the materials and return the questionnaire. The questionnaire is reproduced in Appendix 1.

THE EVALUATORS

Twelve 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 XENO III

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

Mean rating for ‘ease of use’

Three evaluators (25%) used as many as three different systems. The principal reasons for the choice of these materials were good results, reliability and ease of use. Other reasons reported were single step, no sensitivity, 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

4.6

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 4

16-201

>207

EVALUATION OF XENO III

EVALUATION OF THE KIT AND MATERIAL AFTER FAMILIARISATION- REPLIES TO SECTION II.

Evaluators rated the presentation of the material as follows:

ExcellentPoor

4.4

5 1

Comments from evaluators included:

“ Box flimsy, uninspiring design”

“ Prefer single use, blister packs”

The laminated instruction chart was rated as follows by the evaluators:

ExcellentPoor

4.6

5 1

Comments included:

“Good size, fitted drawer OK”

“Doesn’t explain why there are 2 different shaped Dappens dishes”

The printed instructions leaflet was rated by the evaluators as follows:

ExcellentPoor

4.4

5 1

Comments included:

“Poor diagrams and need for pulp protection is disputed”

“Laminated chart easier to follow – why have both”

EVALUATION OF XENO III IN CLINICAL USE: REPLIES TO SECTION III.

The total number of restorations placed during the evaluation was 467, comprised as follows:

Class I90

Class II115

Class III102

Class IV36

Class V124

When the evaluators were asked if Xeno III was used for other applications, 3 evaluators (25%) stated that they used the material for the pre-treatment of indirect restorations, 4 evaluators (33%) for the treatment of dentinal hypersensitivity and 1 evaluator (8%) for the repair of fractured porcelain. Other uses cited were for amalgam bonding and to re-cement a fractured dentine bonded crown and core back onto the root surface.

83% (n=10) of the evaluators stated that the Xeno III green bottle (A) worked satisfactorily. Comments from the other evaluators were:

“Slow delivery” (2)

“Drips down bottle neck”

All 100% of the evaluators stated that the yellow bottle (B) worked satisfactorily and that the liquids from both bottles mixed satisfactorily.

Two evaluators commented:

“BUT not totally confident fully mixed as streaks of different phases visible”

When the evaluators were asked to give their, and their DSA’s assessment of a) the dispensing and handling of the Xeno III bond liquids, and b) the viscosity of the mixed bonding liquids the results was as follows:

a) Dispensing and handling

ConvenientInconvenient

3.7

5 1

b) Viscosity of the mixed bond liquids:

Too viscousToo thin

3.1

5 1

All 100% of the evaluators and their nurses stated that the mixed bonding liquids were easily applied to the brush tip and the tooth.

75% (n=9) of the evaluators stated that the bonding liquid did not give a frosted appearance after application but the remaining 3 (25%) stated a slight frosted appearance was visible.

Ten (83%) of the evaluators felt that it was an advantage not to have to wash off etchant when using Xeno III.

When the evaluators were asked to describe how Xeno III mixed bonding liquid compared with the application of other resins used the results were as follows:

Better42% (5)

Worse8% (1)

Same33% (4)

Messier8% (1)

Less messy33% (4)

One evaluator commented: “more complicated and messier is OK only if superior bond strength is guaranteed!”

When the evaluators were asked if Xeno II was faster or slower than the bonding system normally used the result was as follows:

Faster 42% (5)

Slower33% (4)

Same25% (3)

75% (n=9) of the evaluators stated that the dental nurse experienced no difficulties in using Xeno III. Comments made by the remainder included:

“Green bottle (A) slow to dispense” (2)

“Confusing bottles at first – one shaken, one not & one squeezed and one not”

When the evaluators were asked if they would purchase Xeno III, if available at average cost, 67% (n=8) stated that they would, with one abstention (“not sure”).

Comments made when the evaluators were asked of any changes were essential to the acceptability of Xeno III included:

“ By the time you’ve mixed A and B together you may as well have etched and bonded” (2)

“ Put in single use blister packs with applicator” (2)

“ Bottles would be better with ‘flip’ top.”

When the evaluators were asked to rate the overall ease of use of Xeno III the result was as follows:

Easy to useDifficult to use

4.2

5 1

Final comments included:

“I etch every case so no advantage not to etch”

“The material damaged any tissue it contacted” (2)

“Cannot store bottles upright in box”

“No post-op sensitivity reported”

“Unhappy about mixing liquids – some products volatile so does composition change with resultant alteration of bond strength?”

“Could the 2 liquids be packaged in one bottle?”

“Mixing not so easy as Clearfil for the nurse”

“Bond strength?? Is it better than Prime & Bond NT?”

DISCUSSION AND CONCLUSIONS

The Xeno III bonding system has been subjected to an extensive evaluation in clinical practice in which 467 restorations were placed by members of the PREP panel. Based on this the following conclusions may be made:

Presentation:Both the presentation and the instructions scored well (4.4 and 4.6/4.4 respectively on a visual analogue scale where 5 = excellent and 1 = poor).

Ease of use:Xeno III was rated slightly lower by the evaluators for ease of use when compared with the overall rating for the normally used dentine bonding system system, (4.2 versus 4.6 on a visual analogue scale where 5 = easy to use and 1 = difficult to use) but was equal to or better than the score for ease of use of 3 of the individual normally used systems.

Viscosity:Xeno III achieved an almost ideal score for viscosity (3.1 a visual analogue scale where 5 = too viscous and 1 = too thin) of the mixed bonding liquids.

The lack of the need to wash off etchant was seen as ‘very advantageous’ by 83% (n=10) of the evaluators.

The positive reception of this bonding material is underlined by the fact that the majority of the evaluators (67%) would purchase the material if available at average cost and if some of the changes were suggested by the evaluators were implemented this figure would further improve.