Clinical Evaluation of a Dental Glass Ceramic

April 2, 2025 updated by: Ivoclar Vivadent AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inlay/Onlay
shades A1, A2 and A3
Device: indirect restorative treatment with a glass ceramic
Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate of Inlays and Onlays
Time Frame: Baseline (7-10 days after insertion of restoration)
Inlay and onlay restorations were examined by a dentist
Baseline (7-10 days after insertion of restoration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Criteria (Modified FDI Criteria)
Time Frame: Baseline (7-10 days after insertion of restoration)
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 (7-10 days after insertion of restoration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Actual)

November 15, 2021

Study Completion (Actual)

November 15, 2021

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)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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