Clinical Evaluation of a New Dual-cure Universal Adhesive

Not Applicable

Recruiting

• Conditions: Class I Dental Restorations; Class II Dental Restorations; Insufficient Dental Restoration; Caries, Dental
• Interventions: Device: Placement of indirect dental restoration

• Registration Number: NCT06615544
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2024-11-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-08
• Study Completion: 2031-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New dual-cure adhesive	Placement of indirect dental restoration	The newly developed dual-cure adhesive will be used for the placement of indirect restorations.

Primary Outcome Measures

Name	Time	Method
Postoperative hypersensitivity	1 month	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Secondary Outcome Measures

Name	Time	Method
Fracture rate	5 years	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Marginal quality	5 years	will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)

Trial Locations

Locations (1)

Ivoclar Vivadent AG; 🇱🇮 Schaan, Liechtenstein