Description

CLEARFIL AP-X is a light-cured, radiopaque, microhybrid composite indicated for both anterior and posterior restorations. The material contains 86% filled by weight and is reported to have polymerization shrinkage of 1.9%. In a syringe, the composite is available in 11 Vita shades, two translucent shades and one bleach shade. The Pre-Loaded Tips (PLTs) are available in six Vita shades, one translucent shade and one bleach shade. CLEARFIL AP-X is available in the CLEARFIL SE BOND Restorative kit. The kit includes 10 tips each of CLEARFIL AP-X in A2, A3, B2, and XL (translucent extra-light) shades, and CLEARFIL SE BOND self-etching primer and adhesive.

CLEARFIL SE PROTECT is a 6^th-generation bonding system comprised of a self-etching primer and light-cured adhesive. It contains the same proprietary technology and physical properties as CLEARFIL SE BOND with two additional features: long-term fluoride release and the MDPB monomer that has an antibacterial, cavity-cleansing effect. The kit includes 6 ml of primer, 5 ml of adhesive, a dispensing case, and accessories. This product received a 96% clinical rating.

CLEARFIL S³ BOND is a 7^th-generation bonding system comprised of a self-etching primer/adhesive in a single bottle. It is indicated for bonding light-cured composite restorations, porcelain repair, cavity sealing for indirect preparations, and treatment of exposed root surfaces. it is available in a 4-ml bottle or 0.1-ml single-dose applicators. This product received a 97% clinical rating.

Purpose

Some composite restorations show microleakage with the use of 6^th– and 7^th-generation bonding agents. The purpose of this study was to determine the clinical performance of CLEARFIL AP-X PLT with 6^th– and 7^th-generation bonding agents at 6- and 12-months.

Clinical Evaluation Protocol

• 160 CLEARFIL AP-X restorations were placed in 82 patients.
• All restorations were bonded with either CLEARFIL S³ BOND or CLEARFIL SE PROTECT.
• Ninety-one restorations were recalled at 6- and 12-months. Of those recalled, 60% were bonded with CLEARFIL S³ BOND and 40% with CLEARFIL SE PROTECT.
• At the time of recall, the following parameters were assessed on a scale of 1 – 5 (1 = poor, 2 = fair, 3 = good, 4 = very good, and 5 = excellent):
  • Lack of sensitivity
  • Resistance to marginal staining/microleakage
  • Resistance to fracture/chipping
  • Shade match/esthetics/discoloration

Clinical Observations

Sensitivity
Sensitivity was based on the patients’ reporting of discomfort after placement of the restoration. One hundred percent of CLEARFIL S3 BOND restorations recalled at 6- and 12-months were rated as excellent. Ninety-seven percent of restorations bonded with CLEARFIL SE PROTECT were rated as excellent at the time of recalls. One patient treated with CLEARFIL SE PROTECT reported slight sensitivity at both the 6-month and 12-month recall, rating the sensitivity as mild.

Microleakage
Restorations were evaluated by visual observation for marginal staining as an indicator of microleakage. Nine percent of CLEARFIL S³ BOND restorations recalled at 6-months and 16% of restorations at 12-months exhibited evidence of mild-to-minimal marginal staining. Eight percent of CLEARFIL SE PROTECT restorations recalled at 6-months and 14% of restorations recalled at 12-months showed signs of mild-to-minimal staining.

Resistance to Fracture/Chipping
One hundred percent of the CLEARFIL SE PROTECT restorations were resistant to fracture and chipping, receiving an excellent rating at both 6-month and 12-month recalls. Of the 55 CLEARFIL S³ BOND restorations recalled, one restoration, tooth #15-O, showed signs of slight chipping. This restoration was recontoured and replacement was not required. The remaining CLEARFIL S³ BOND restorations rated excellent at recall.

Esthetics
The overall esthetics of CLEARFIL AP-X PLT using both bonding systems was very good. Eighty-six percent of CLEARFIL S³ BOND restorations and 92% of CLEARFIL SE PROTECT restorations received ratings of excellent for esthetics at recalls. Although no discoloration was noted, some clinicians reported the restorations appeared grainy.

Summary
The clinical performance of 6^th– and 7^th-generation self-etching adhesives has improved significantly, allowing adhesive restorations to be placed with a highly predictable level of clinical success. The performance of both CLEARFIL S³ BOND and CLEARFIL SE PROTECT was excellent during this 12-month clinical study. Both bonding systems were found to be equivalent in lack of sensitivity and resistance to microleakage, with only a small number of restorations exhibiting mild-to-minimal microleakage.