Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy

A post market clinical follow up study (PMCF) with a glass ceramic 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Trauma; Caries
• Intervention / Treatment: Device: indirect restorative treatement with a glass ceramic

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Schaan, Liechtenstein, 9494
    • Ivoclar Vivadent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-CoV2 infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival rate of inlays and onlays	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Criteria (modified FDI criteria)	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)	Baseline to 5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Anticipated): August 1, 2027
• Study Completion (Anticipated): August 1, 2027

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LL3965040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No