N/A
Completed N=36
In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography
Cavity · Cavities of Teeth
Source: ClinicalTrials.gov NCT05145322 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Marginal Staining: World Dental Federation (FDI) Criteria - Baseline — 18; 18; 0; 0 Participants
Summary
The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Marginal Staining: World Dental Federation (FDI) Criteria - Baseline |
18; 18; 0; 0; 0; 0 | — |
| PRIMARY Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up |
16; 17; 0; 0; 0; 0 | — |
| PRIMARY Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up |
14; 13; 0; 0; 0; 0 | — |
| PRIMARY Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline |
18; 18; 0; 0; 0; 0 | — |
| PRIMARY Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up |
16; 17; 0; 0; 0; 0 | — |
| PRIMARY Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up |
14; 13; 0; 0; 0; 0 | — |
| PRIMARY Marginal Defect: World Dental Federation (FDI) Criteria - Baseline |
7; 8; 11; 10 | — |
| PRIMARY Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up |
12; 12; 4; 5 | — |
| PRIMARY Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative |
8; 7; 6; 6 | — |
| PRIMARY Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline |
18; 18; 0; 0; 0; 0 | — |
| PRIMARY Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up |
16; 17; 0; 0; 0; 0 | — |
| PRIMARY Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative |
14; 13; 0; 0; 0; 0 | — |
| SECONDARY Backscattered Intensity at the Occlusal Cavosurface Angle. |
6.75; 1.56 | — |
| SECONDARY Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. |
14.44; 18.75 | — |
| SECONDARY Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls |
16.20; 7.43 | — |
Eligibility Criteria
Inclusion Criteria
- Good general health
- Fair oral hygiene
- At least 20 teeth in occlusion
- Available for the duration of the study
Tooth-level inclusion Criteria:
- Participants with occlusal caries lesion/s in permanent posterior dentition except wisdom teeth
- Caries lesion can be primary or secondary caries.
- Caries lesion is in the International Caries Detection and Assessment System (ICDAS) 4 or 5 category.
- The extent of the caries lesion bucco-lingually is likely not to exceed two-thirds of the occlusal table.
- The selected tooth must be able to be isolated with either rubber dam or other isolation technique during clinical procedure.
- The selected tooth must have an opposing antagonist.
- The selected tooth should be periodontally healthy.
Exclusion Criteria
- Signs of bruxism
Tooth-level exclusion criteria:
- Wisdom teeth
- Present with irreversible pulpitis.
- Periodontally compromised tooth that may require extraction.
- Caries lesions that would require cuspal coverage.
Data sourced from ClinicalTrials.gov (NCT05145322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.