Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Ivoclar Vivadent

Status

Terminated

Conditions

Dental Caries

Defective Tooth Restorations

Treatments

Device: Adhese Universal DC

Device: Adhese Universal

Study type

Interventional

Funder types

Industry

Identifiers

NCT04475679

LL3615088

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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