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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04933123
• Other study ID #: LL3965040
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: August 1, 2027

Study information

• Verified date: June 2021
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries
• Dental Trauma

Intervention

Device:
• indirect restorative treatement with a glass ceramic
Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.

Locations

Country	Name	City	State
Liechtenstein	Ivoclar Vivadent	Schaan

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

Liechtenstein, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of inlays and onlays		5 years
Secondary	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