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).

Study Overview

• Status: Active, not recruiting
• Conditions: Caries; Defective Restorations
• Intervention / Treatment: Device: Alcasite restorative material; Device: Bulk fill glass hybrid restorative material

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcasite restorative material	Device: 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
Active Comparator: Bulk fill glass hybrid restorative material	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Success: Scores equal to/above 3)	6 months to 3 years
Survival Rate	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations (Survival: Score equal to/above 4)	6 months to 5 years
Quality criteria (Clinical performance)	assessed following FDI criteria on a scale from 1 "very good" to 5 "unacceptable": e.g. post-operative hypersensitivity, surface lustre, staining, fracture of material, retention, occlusal contour and wear, and colour match of restorations	6 months to 5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LL4199644; S66086 (Other Identifier: KU Leuven)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No