NCT04475679

Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.

Detailed description

This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth vitality and failure rate of placed restorations. Tooth vitality is an indicator for the health status of the dental pulp. A vitality test is performed to acquire information about the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test. Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the vitality test.

Conditions

• Dental Caries
• Defective Tooth Restorations

Interventions

Type	Name	Description
DEVICE	Adhese Universal DC	Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth surface
DEVICE	Adhese Universal	Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2020-07-17
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

1 site across 1 country: Liechtenstein