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

Sponsor
Ivoclar Vivadent AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04933123
Collaborator
(none)
40
Enrollment
1
Location
70.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: indirect restorative treatement with a glass ceramic
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Outcome Measures

Primary Outcome Measures

  1. Survival rate of inlays and onlays [5 years]

Secondary Outcome Measures

  1. Quality Criteria (modified FDI criteria) [Baseline to 5 years]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ivoclar Vivadent Schaan Liechtenstein 9494

Sponsors and Collaborators

  • Ivoclar Vivadent AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ivoclar Vivadent AG
ClinicalTrials.gov Identifier:
NCT04933123
Other Study ID Numbers:
  • LL3965040
First Posted:
Jun 21, 2021
Last Update Posted:
May 6, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2022