An interventional study of Placement of indirect dental restoration in Class I Dental Restorations, Class II Dental Restorations and Insufficient Dental Restoration, sponsored by Ivoclar Vivadent AG. Active, not recruiting at 1 site in Liechtenstein. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-23.
Sponsored by Ivoclar Vivadent AG · Not applicable, Interventional, and 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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Ivoclar Vivadent AG is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Device: Placement of indirect dental restoration
The newly developed dual-cure adhesive will be used for the placement of indirect restorations.
Postoperative Hypersensitivity
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 1 month
Fracture Rate
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 5 years
Marginal Quality
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Time frame: 5 years
| Milestone | New dual-cure adhesive |
|---|---|
| Started | 45 |
| Completed | 45 |
| Not completed | 0 |
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
| Restorations | New dual-cure adhesive |
|---|---|
| FDI Score 1 | 46 |
| FDI Score 2-5 | 0 |
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Results for this outcome have not been posted.
will be assessed according to FDI criteria (grade 1-5, lower scores mean a better outcome)
Results for this outcome have not been posted.
Collected over 1-Month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New dual-cure adhesive | 0/45 (0%) | 0/45 (0%) | 3/45 (6.7%) |
| Event | New dual-cure adhesive |
|---|---|
| Unrealated: Cementation MistakeGeneral disorders | 2/45 |
| Unrealated: Cementation MistakeGeneral disorders | 1/45 |
| Age, Categorical(Participants) | New dual-cure adhesive |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | New dual-cure adhesive |
|---|---|
| Female | 15 |
| Male | 30 |
| Race and Ethnicity Not Collected(Participants) | New dual-cure adhesive |
|---|
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Plan to share: No
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Ivoclar Vivadent AG