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NCT Number: NCT05748327

Trial With Two New Tooth-colored Restorative Materials 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Alcasite restorative material

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

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

Primary outcomes

  1. Success Rate

    Time frame: 5 years

    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)

Secondary outcomes

  1. Success Rate

    Time frame: 6 months to 3 years

    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)

  2. Survival Rate

    Time frame: 6 months to 5 years

    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)

  3. Quality criteria (Clinical performance)

    Time frame: 6 months to 5 years

    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

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2023
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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