Clinical Evaluation of a Dental Glass Ceramic

Ivoclar Vivadent

Status

Terminated

Conditions

Dental Trauma

Caries

Treatments

Device: indirect restorative treatment with a glass ceramic

Study type

Interventional

Funder types

Industry

Identifiers

NCT04933123

LL3965040

Details and patient eligibility

About

A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.

Enrollment

13 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)
Pre-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.
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
Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection