Class I Dental RestorationsNCT06615544
Clinical Evaluation of a New Dual-cure Universal Adhesive
A study testing Placement of indirect dental restoration in people with Class I Dental Restorations and Class II Dental Restorations, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.
Trial summary
The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Class I Dental Restorations, Class II Dental Restorations, Insufficient Dental Restoration
- What is being tested?
- Placement of indirect dental restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteLiechtenstein
- Study dates
- 4 Nov 2024to Apr 2031
- 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
- Informed consent signed and understood by the subject
- Indication for indirect restorations (inlay, onlay) in molar or premolar
- The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
- visual analogue scale (VAS)\<4 (0=no pain, 10=maximum conceivable pain)
- 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
- Insufficient isolation
- 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
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- Tooth with irreversible pulpitis
- Indication for direct pulp capping
- Bleaching of teeth within the last 14 days
- Usage of peroxide-based disinfectants within the last 14 days
Trial locations and contacts
1 site in 1 country.
Liechtenstein1 site
Ivoclar Vivadent AG
Schaan, 9494
About this study
Official title: Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment
The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.
- Conditions
- Class I Dental Restorations, Class II Dental Restorations, Insufficient Dental Restoration, Caries, Dental
- Being tested
- Placement of indirect dental 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.
Placement of indirect dental restorationDevice
The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
| Study group | Role | What they receive |
|---|---|---|
| New dual-cure adhesive | Experimental | The newly developed dual-cure adhesive will be used for the placement of indirect restorations. Receives: Device: Placement of indirect dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hypersensitivity
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Measured: 1 month
Secondary outcomes (2)
Fracture Rate
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Measured: 5 years
Marginal Quality
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start4 Nov 2024
- Primary completion27 Mar 2025
- Study completionApr 2031 (estimated)
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 Class I Dental RestorationsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT06615544
- Sponsor's protocol ID
- OTCS187092274
- Status last verified
- Nov 2026
- First submitted
- 24 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment
- ClinicalTrials.gov ID
- NCT06615544
- Acronym / sponsor ID
- OTCS187092274
- Conditions
- Class I Dental Restorations, Class II Dental Restorations, Insufficient Dental Restoration, Caries, Dental
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- Apr 2031 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New dual-cure adhesive | Experimental | Device: Placement of indirect dental restorationThe newly developed dual-cure adhesive will be used for the placement of indirect restorations. |
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
- Informed consent signed and understood by the subject
- Indication for indirect restorations (inlay, onlay) in molar or premolar
- The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
- visual analogue scale (VAS)\<4 (0=no pain, 10=maximum conceivable pain)
Key exclusion criteria (10 listed)
- Insufficient isolation
- 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 |
|---|---|---|
| Placement of indirect dental restorationThe newly developed dual-cure adhesive will be used for the placement of indirect restorations. | Device | New dual-cure adhesive |
Primary outcome
Postoperative Hypersensitivity
Time frame: 1 month
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
2 secondary outcomes
Fracture Rate
Time frame: 5 years
Marginal Quality
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Class I Dental Restorations
RecruitingObservational study
Evaluation of the Effect of Flowable Composites on Postoperative Sensitivity in Class I Restorations.
Dentin Caries
Active, not recruiting
Clinical Performance of Injectable Composite Resins in Class I Cavities
Caries,Dental
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
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 Placement of indirect dental restoration in people with Class I Dental Restorations and Class II Dental 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 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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 19 Aug 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?
Postoperative Hypersensitivity (time frame: 1 month). 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 Nov 2026.