Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

January 9, 2025 updated by: Ivoclar Vivadent AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adhese Universal DC
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
Active Comparator: Adhese Universal
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
Time Frame: Baseline (7-10 days)
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 (7-10 days)
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: 12 months
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"
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: Baseline
assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Baseline
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: Baseline
assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Baseline
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
Time Frame: Baseline
assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Baseline
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: Baseline
assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Baseline
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: 12 months
assessed by a cold stimuli test on the patient teeth (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
12 months
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: 12 months
assessed on patient teeth by checking tooth integrity (looking for enamel cracks, tooth fractures) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
12 months
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
Time Frame: 12 months
assessed on patient teeth (checking inlays/onlays for fractures, cracks, small hairline cracks, chip fractures, material damage) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
12 months
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
Time Frame: 12 months
assessed on the patient teeth (looking for marginal gaps/Fractures, checking outlines) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL3615088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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