Clinical trial NCT04475679: Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
Official title: Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dental Caries
Defective Tooth Restorations
Keywords: caries
restoration
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.

Detailed description: This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.

Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
* 2-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
* 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:

* Sufficient isolation not possible, dry working field cannot be guaranteed
* 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
* Nonvital tooth or tooth with irreversible pulpitis
* Indication for direct pulp capping
* Symptoms of SARS-CoV2 infection

Primary outcomes:
measure: FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
timeFrame: Baseline (7-10 days)
measure: FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: 12 months
Secondary outcomes:
measure: Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: Baseline
measure: FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: Baseline
measure: FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
timeFrame: Baseline
measure: FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: Baseline
measure: Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: 12 months
measure: FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: 12 months
measure: FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
timeFrame: 12 months
measure: FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
timeFrame: 12 months
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent
Study officials:
References: