Dental CariesNCT04475679
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
A study testing Adhese Universal DC and Adhese Universal in people with Dental Caries and Defective Tooth Restorations, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Caries, Defective Tooth Restorations
- What is being tested?
- Adhese Universal DC and Adhese Universal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 14 Sep 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Show all 9Show fewer
- Nonvital tooth or tooth with irreversible pulpitis
- Indication for direct pulp capping
- Symptoms of SARS-CoV2 infection
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent
Schaan, 9494
About this study
Official title: 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.
Read the 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
- Being tested
- Adhese Universal DC, Adhese Universal
- Keywords
- caries, restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhese Universal DCDevice
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
Adhese UniversalDevice
Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth
| Study group | Role | What they receive |
|---|---|---|
| Adhese Universal DC | Experimental | Not described Receives: Device: Adhese Universal DC |
| Adhese Universal | Active comparator | Not described Receives: Device: Adhese Universal |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
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"
Measured: Baseline (7-10 days)
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: 12 months
Secondary outcomes (8)
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: Baseline
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: Baseline
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
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"
Measured: Baseline
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: Baseline
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: 12 months
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: 12 months
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
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"
Measured: 12 months
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
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"
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start14 Sep 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: not sufficient cases for recall to investigate performance of test product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivoclar Vivadent AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475679
- Sponsor's protocol ID
- LL3615088
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04475679
- Acronym / sponsor ID
- LL3615088
- Conditions
- Dental Caries, Defective Tooth Restorations
- Keywords
- caries, restoration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not sufficient cases for recall to investigate performance of test product
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhese Universal DC | Experimental | Device: Adhese Universal DC |
| Adhese Universal | Active comparator | Device: Adhese Universal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhese Universal DCAdhese 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 DC |
| Adhese UniversalAdhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic DC to bond indirect restorations to the tooth | Device | Adhese Universal |
Primary outcome
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"
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"
8 secondary outcomes
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: Baseline
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: Baseline
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
Time frame: Baseline
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: Baseline
Vitality of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: 12 months
FDI 13 Fracture of Restored Teeth After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: 12 months
FDI 5 Retention/Fracture of Restorations After Inlays/Onlays Restorations, FDI Score 1-5
Time frame: 12 months
FDI 6 Marginal Quality After Inlay/Onlay Restorations, FDI Score 1-5
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhese Universal DC and Adhese Universal in people with Dental Caries and Defective Tooth Restorations, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Liechtenstein. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5 (time frame: Baseline (7-10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.