Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities

Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities

This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Inclusion Criteria:

• Subject's age between 18 and 65 years old
• Class I and Class II (with a cavity margin 1-1.5 mm from the cusp tip) (caries treatment, removal of existing defective amalgam/composite restorations), on premolars/molars
• Vital teeth
• 2 restorations per patient: both cavities should have comparable size and dimensions
• Presence of neighbour tooth and antagonist (molars with no neighbour tooth at the distal side can also be included)
• Low to moderate caries rate/normal periodontal status with good home care

Exclusion Criteria:

• Hospitalized and medically compromised patients (medical history may not compromise the outcome of the results)
• Pulp exposure or signs of pulpal infection
• No signs of pulpitis or hypersensitivity (Visual analog scale < 3 on biting and temperature sensitivity)
• History of allergy to glass ionomer, acrylate/methacrylate monomers
• Pregnancy
• Chronic disease with oral manifestations or primary oral pathology
• Bad oral hygiene
• High caries rate or periodontal problems
• Absence of antagonists
• Absence of adjacent teeth (except last molar in the row with no neighbour tooth at the distal side)