Clinical Evaluation of a New Dual-cure Universal Adhesive

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caries, Dental; Class II Dental Restorations; Class I Dental Restorations; Insufficient Dental Restoration
• Intervention / Treatment: Device: Placement of indirect dental restoration

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Liechtenstein
    • Schaan, Liechtenstein, Liechtenstein, 9494
      • Ivoclar Vivadent AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New dual-cure adhesive; The newly developed dual-cure adhesive will be used for the placement of indirect restorations.	Device: Placement of indirect dental restoration; The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Hypersensitivity	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Rate	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)	5 years
Marginal Quality	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)	5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: OTCS187092274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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