Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Adhese Universal DC	Adhese Universal DC	-
Adhese Universal	Adhese Universal	-

Primary Outcome Measures

Name	Time	Method
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5	Baseline (7-10 days)	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"
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5	12 months	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"

Secondary Outcome Measures

Name	Time	Method
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5	12 months	assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5	12 months	assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5	12 months	assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5	12 months	assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"