Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06615544

Clinical Evaluation of a New Dual-cure Universal Adhesive

The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Class I Dental Restorations Caries, Dental Class II Dental Restorations Dental Caries Insufficient Dental Restoration Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-65 years
  • Informed consent signed and understood by the subject
  • Indication for indirect restorations (inlay, onlay) in molar or premolar
  • The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
  • visual analogue scale (VAS)<4 (0=no pain, 10=maximum conceivable pain)
  • Max. 2 restorations per participant in different quadrants.
  • Vital tooth
  • Healthy periodontium, no active periodontitis
  • Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
  • Sufficient language skills

Exclusion criteria

  • Insufficient isolation
  • Participants with a proven allergy to one of the ingredients of the materials used
  • Participants with proven allergy to local anaesthetics
  • High caries activity/ poor oral hygiene
  • Participants with severe systemic diseases
  • Pregnancy
  • Tooth with irreversible pulpitis
  • Indication for direct pulp capping
  • Bleaching of teeth within the last 14 days
  • Usage of peroxide-based disinfectants within the last 14 days

Treatment and study plan

Placement of indirect dental restoration

Device

The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

Primary outcomes

  1. Postoperative Hypersensitivity

    Time frame: 1 month

    will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Secondary outcomes

  1. Fracture Rate

    Time frame: 5 years

    will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

  2. Marginal Quality

    Time frame: 5 years

    will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment

Important dates

Study start
2024
Primary completion
2025
Study completion
2031
First posted
Sep 26, 2024
Registry last updated
Oct 23, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.