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

NCT ID: NCT05748327

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2028-04-01

Brief Summary

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).

Detailed 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.

Conditions

Caries; Defective Restorations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alcasite restorative material

Group Type: EXPERIMENTAL

Alcasite restorative material

Intervention Type: DEVICE

Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing

Bulk fill glass hybrid restorative material

Group Type: ACTIVE_COMPARATOR

Bulk fill glass hybrid restorative material

Intervention Type: DEVICE

Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing

Interventions

Alcasite restorative material

Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing

Intervention Type: DEVICE

Bulk fill glass hybrid restorative material

Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S66086

Identifier Type: OTHER

Identifier Source: secondary_id

LL4199644

Identifier Type: -

Identifier Source: org_study_id