Clinical Evaluation of a New Dual-cure Universal Adhesive

Launched by IVOCLAR VIVADENT AG · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of dental adhesive called a "dual-cure universal adhesive." The main goal is to see how well this adhesive works and how safe it is when used for placing indirect restorations, like inlays or onlays, in teeth. Specifically, researchers want to find out if using this adhesive leads to any sensitivity or pain after treatment. They will also look at how well the restorations hold up over time and whether the teeth stay healthy.

To participate in the study, you need to be between 18 and 65 years old and have a need for indirect restorations in your molars or premolars. You should have a healthy tooth that is not infected and not experiencing significant pain. Participants will undergo the dental procedure using the new adhesive, and they will be monitored for any reactions or issues afterward. It's important to note that certain conditions, like allergies to ingredients used in the adhesive or recent teeth bleaching, may prevent you from joining the trial. If you're interested and meet the criteria, this study could help improve dental treatments for many people!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18-65 years
• • Informed consent signed and understood by the subject
• • Indication for indirect restorations (inlay, onlay) in molar or premolar
• • The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
• • visual analogue scale (VAS)\<4 (0=no pain, 10=maximum conceivable pain)
• • Max. 2 restorations per participant in different quadrants.
• • Vital tooth
• • 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:
• • Insufficient isolation
• • 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
• • Tooth with irreversible pulpitis
• • Indication for direct pulp capping
• • Bleaching of teeth within the last 14 days
• • Usage of peroxide-based disinfectants within the last 14 days