Clinical Evaluation of a New Dual-cure Universal Adhesive

NCT06615544 | Active Not Recruiting Results

• 1 other identifier: OTCS187092274
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class I Dental Restorations; Class II Dental Restorations; Insufficient Dental Restoration; Caries, Dental

Outcome Measures

Primary Outcomes (1)

• Postoperative Hypersensitivity

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

  1 month

Secondary Outcomes (2)

• Fracture Rate

  5 years

• Marginal Quality

  5 years

Study Arms (1)

New dual-cure adhesive

EXPERIMENTAL

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

Device: Placement of indirect dental restoration

Interventions

Placement of indirect dental restoration DEVICE

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

New dual-cure adhesive

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Head of Department Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: November 4, 2024
• Primary Completion: March 27, 2025
• Study Completion (Estimated): April 1, 2031
• Last Updated: October 23, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)