Clinical Evaluation of a Dental Glass Ceramic

NCT04933123 | Terminated Results

• 1 other identifier: LL3965040
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Survival Rate of Inlays and Onlays

  Inlay and onlay restorations were examined by a dentist

  Baseline (7-10 days after insertion of restoration)

Secondary Outcomes (1)

• Quality Criteria (Modified FDI Criteria)

  Baseline (7-10 days after insertion of restoration)

Study Arms (1)

Inlay/Onlay

EXPERIMENTAL

shades A1, A2 and A3

Device: indirect restorative treatment with a glass ceramic

Interventions

indirect restorative treatment with a glass ceramic DEVICE

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

Inlay/Onlay

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (1)

Ivoclar Vivadent

Schaan, 9494, Liechtenstein

Location

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 21, 2021
• Study Start: September 14, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: April 20, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)