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Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

Primary Purpose

Dental Caries, Defective Tooth Restorations

Status
Active
Phase
Not Applicable
Locations
Liechtenstein
Study Type
Interventional
Intervention
Adhese Universal DC
Adhese Universal
Sponsored by
Ivoclar Vivadent AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring caries, restoration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ivoclar Vivadent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adhese Universal DC

Adhese Universal

Arm Description

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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"
fracture rate of restored teeth
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
retention/fracture rate of restorations
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
marginal quality
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"

Full Information

First Posted
July 8, 2020
Last Updated
April 8, 2022
Sponsor
Ivoclar Vivadent AG
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1. Study Identification

Unique Protocol Identification Number
NCT04475679
Brief Title
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
Official Title
Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivoclar Vivadent AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Defective Tooth Restorations
Keywords
caries, restoration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adhese Universal DC
Arm Type
Experimental
Arm Title
Adhese Universal
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Adhese Universal DC
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Adhese Universal
Intervention Description
Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
Primary Outcome Measure Information:
Title
postoperative hypersensitivity
Description
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"
Time Frame
Baseline to 60 months
Secondary Outcome Measure Information:
Title
loss of vitality of restored teeth
Description
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"
Time Frame
Baseline to 60 months
Title
fracture rate of restored teeth
Description
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Time Frame
Baseline to 60 months
Title
retention/fracture rate of restorations
Description
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Time Frame
Baseline to 60 months
Title
marginal quality
Description
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
Time Frame
Baseline to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ivoclar Vivadent
City
Schaan
ZIP/Postal Code
9494
Country
Liechtenstein

12. IPD Sharing Statement

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Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy

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