Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04475679
• Other study ID #: LL3615088
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2022
• 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: July 12, 2021
• 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)

• 2-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.

• 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:

• 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

• Nonvital tooth or tooth with irreversible pulpitis

• Indication for direct pulp capping

• Symptoms of SARS-CoV2 infection

Related Conditions & MeSH terms

• Defective Tooth Restorations
• Dental Caries

Intervention

Device:
• Adhese Universal DC
Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface
• Adhese Universal
Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth

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	postoperative hypersensitivity	assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 60 months
Secondary	loss of vitality of restored teeth	assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 60 months
Secondary	fracture rate of restored teeth	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 60 months
Secondary	retention/fracture rate of restorations	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 60 months
Secondary	marginal quality	assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"	Baseline to 60 months