Clinical Evaluation of a New Dual-cure Universal Adhesive

Ivoclar Vivadent

Status: Active, not recruiting

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

Treatments: Device: Placement of indirect dental restoration

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615544

OTCS187092274

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

New dual-cure adhesive

Experimental group

Description:

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

Treatment:

Device: Placement of indirect dental restoration