Status:
TERMINATED
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
Lead Sponsor:
Ivoclar Vivadent AG
Conditions:
Dental Caries
Defective Tooth Restorations
Eligibility:
All Genders
18-65 years
Phase:
NA
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 premol...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04475679
Start Date
September 14 2020
End Date
July 30 2021
Last Update
February 4 2025
Active Locations (1)
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1
Ivoclar Vivadent
Schaan, Liechtenstein, 9494