Clinical Evaluation of a Dental Glass Ceramic

NCT ID: NCT04933123

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2021-11-15

Brief Summary

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.

Conditions

Caries; Dental Trauma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inlay/Onlay

shades A1, A2 and A3

Group Type: EXPERIMENTAL

indirect restorative treatment with a glass ceramic

Intervention Type: DEVICE

Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.

Interventions

indirect restorative treatment with a glass ceramic

Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ivoclar Vivadent

Schaan, , Liechtenstein

Countries

Liechtenstein

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LL3965040

Identifier Type: -

Identifier Source: org_study_id