Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial

Conditions
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Dental Caries, Defective Tooth Restorations

Intervention / Treatment
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* Device: Adhese Universal DC
* Device: Adhese Universal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhese Universal DC<br> | Device: Adhese Universal DC<br>* Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface<br>|
| Active Comparator: Adhese Universal<br> | Device: Adhese Universal<br>* Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hypersensitivity | assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loss of vitality of restored teeth | assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 60 months | 
| fracture rate of restored teeth | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 60 months | 
| retention/fracture rate of restorations | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 60 months | 
| marginal quality | assessed following the FDI criteria on a scale from 1 very good to 5 unacceptable | Baseline to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, restoration