This study is a clinical trial of the the resin-based restorative material CLEARFIL MAJESTY (the product name of CLEARFIL MAJESTY Esthetic in the Japanese market, also with a difference in shade colours) together with the self-etching adhesive CLEARFIL S3 BOND (CLEARFIL tri-S bond).
A total of 30 restorations were placed in 30 human subjects in caries-free Class V roded/abraded areas in permanent teeth.
The reports after 18 months recorded the satisfactory status of all restorations following recovery from the operative procedure of placement. At the 18 month recall, all restorations that were reviewed were satisfactory in all clinical criteria specified. No failures have so far been observed at all recalls and the Kaplan-Meier probability of survival rate for these restorations after 18 months is 1.00.
Objective of the investigation
This trial will determine the short-term efficacy of CLEARFIL MAJESTY with the self-etching adhesive CLEARFIL S3 BOND (CLEARFIL tri-S bond) as a dentine and enamel adhesive material, in a group of patients under conditions which represent its normal conditions of use.
Design of the investigation
The investigation is a short-term, uncontrolled trial. The design is based on the guidelines of the American Dental Association for assessment of dentine and enamel adhesive materials of 2001. The study originally set out to examine the performance of cervical restorations of at least 30 subjects at recalls at baseline, three months, six months, 12 months, and 18 months.
History of the study discussion
During the months of March and May 2006, 30 trial restorations were placed in a total of 30 patients using the resin-based restorative CLEARFIL MAJESTY in combination with the self-etching adhesive CLEARFIL S3 BOND (CLEARFIL tri-S bond).
Two operators in general dental practices placed all the restorations. Baseline records were made by the practitioners immediately after placement. Patients were followed up routinely at recall intervals that were appropriate to their oral health status, and at each recall the restorations were evaluated for clinical acceptability.
Discussion
During the months of March and May 2006, 30 trial restorations were placed in a total of 30 patients using the resin-based restorative CLEARFIL MAJESTY in combination with the self-etching adhesive CLEARFIL S3 BOND (CLEARFIL™ tri-S bond).
Two operators in general dental practices placed all It is noted to be interesting that all the restorations showed Alpha rating 18 months after placement, and were deemed to be clinically satisfactory in all aspects examined. It seems that the observation period was relatively short but according to the laboratory studies (Uno S et al. Evaluation of bond efficacy of an experimental all-in-one adhesive system SSB-200, Adhes Dent 22(3): 245-253, 2004) the bond strength of this resin bonding system was quite high, as much as 20 MPa to bovine enamel and dentine. Also the FE-SEM study revealed that the tight interfacial junction was obtained between the resin and enamel/dentine, creating the hybrid layer at the dentine interface. These findings support the clinical results of this study.
Conclusion
The resin-based restorative material CLEARFIL MAJESTY and the selfetching adhesive CLEARFIL S3 BOND demonstrated to be a satisfactory dentine and enamel adhesive material for the restoration of caries-free Class V eroded/abraded areas in permanent teeth over a period of 18 months.
Images available on request or refer to the May issue of The Dentist page 78–80.