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

Ivoclar Vivadent

Status

Active, not recruiting

Conditions

Defective Restorations

Caries

Treatments

Device: Alcasite restorative material

Device: Bulk fill glass hybrid restorative material

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05748327

LL4199644

S66086 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

58 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)