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Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
NA trial testing Supreme Universal Restorative in Dental Caries in 53 participants. Completed in 3 July 2021.
| Lead sponsor | Solventum US LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 22 March 2016 |
| Primary completion | 3 July 2021 |
| Estimated completion | 3 July 2021 |
| Sites | 1 location across United States |
Solventum US LLC — full company profile →
Adults 19 to 90, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 94.6 | |
| Flowable Composite | 96.4 | |
| Bulk Fill Flowable Composite | 92.9 |
1. Luster comparable to enamel 2. Slightly dull, not noticeable from speaking distance. 3. Surface is dull but still acceptable if the surface of the restoration is covered with a film of saliva. 4. Surface is rough and not masked by salivary film. Major re-finishing or veneering is necessary and possible. 5. Surface is unacceptably rough which makes it ugly and/or it retains noticeable biofilm (plaque). Improvement by finishing or veneering is not feasible.
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.50 | ± 0.58 |
| Flowable Composite | 1.39 | ± 0.57 |
| Bulk Fill Flowable Composite | 1.41 | ± 0.50 |
1. No surface staining. 2. Minor surface staining (under dry conditions) is present but is evenly spread over all the teeth. It does not affect the aesthetic properties because it is generalized and acceptable. 3. Moderate surface staining not noticeable from a speaking distance. 4. Surface staining is present on the restoration but not the tooth and is clearly recognizable from a speaking distance. The aesthetic properties of the dentition are affected. Restoration requires major correction and layering of new material. 5. Surface staining is totally unacceptable/unsightly and the restoration
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.21 | ± 0.50 |
| Flowable Composite | 1.25 | ± 0.44 |
| Bulk Fill Flowable Composite | 1.19 | ± 0.40 |
1. Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel and adjacent teeth. There is no difference in shade, brightness or translucency between restoration and tooth. 2. Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent. 3. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics. 4. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics. 5. Colour match and/or translucency are clinical
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.36 | ± 0.49 |
| Flowable Composite | 1.32 | ± 0.48 |
| Bulk Fill Flowable Composite | 1.67 | ± 0.73 |
1. No fractures / cracks. 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact. 4. Material chip fractures which damage marginal quality or approximal contacts. 5. Bulk fractures with partial loss (less than half of the restoration).
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.21 | ± 0.79 |
| Flowable Composite | 1.07 | ± 0.38 |
| Bulk Fill Flowable Composite | 1.04 | ± 0.19 |
1. Physiological wear equivalent to enamel. 2. Normal wear only slightly different from that of enamel. 3. Different wear rate than enamel but within the biological variation. 4. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost. 5. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.14 | ± 0.36 |
| Flowable Composite | 1.07 | ± 0.26 |
| Bulk Fill Flowable Composite | 1.11 | ± 0.32 |
1. Complete integrity. 2. Small marginal enamel fracture (\<150 µm) / Hairline crack in enamel (\<150 µm) 3. Marginal enamel defect \<250µm / Crack \<250µm / Enamel chipping 4. Multiple cracks / Major marginal enamel defects; gap \> 250 µm or dentine or base exposed 5. Cusp or tooth fracture
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.00 | ± 0 |
| Flowable Composite | 1.00 | ± 0 |
| Bulk Fill Flowable Composite | 1.00 | ± 0 |
1. No secondary or primary caries 2. Small and localized: Demineralization / Erosion / Abfraction. 3. Larger areas of: Demineralisation / Erosion / Abrasion / abfraction, dentine not exposed. Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries / Erosion in dentine / Abrasion, abfraction in dentine. Localized and accessible can be repaired. 5. Deep caries or exposed dentine that is not accessible for repair of restoration
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.15 | ± 0.60 |
| Flowable Composite | 1.11 | ± 0.57 |
| Bulk Fill Flowable Composite | 1.04 | ± 0.19 |
1. No clinically detectable gap. 2. Marginal integrity deviates from ideal but could be upgraded to ideal by polishing. 3. Leakage/discoloration is present but limited to border area of margins. Generalized marginal gap \>150 µm but \<250 µm, easily perceptible on probing but cannot be modified without minor damage to tooth or surrounding tissue, and is not considered to result in long-term negative consequences for tooth or surrounding tissue if left untreated. Presence of several small marginal fractures that are unlikely to cause long-term effects. 4. Localized gap larger than 250 µm, may r
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.41 | ± 0.57 |
| Flowable Composite | 1.21 | ± 0.42 |
| Bulk Fill Flowable Composite | 1.33 | ± 0.55 |
1. No marginal staining 2. Minor marginal staining, easily removable. 3. Moderate marginal staining, not aesthetically unacceptable. 4. Pronounced (mainly localized) marginal staining and not removable by polishing; major intervention necessary for improvement. of aesthetics 5. Deep marginal staining (generalized and/or profound), not accessible for intervention.
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.33 | ± 0.59 |
| Flowable Composite | 1.29 | ± 0.53 |
| Bulk Fill Flowable Composite | 1.26 | ± 0.59 |
1. Contact is physiological (dental floss can only be inserted into the interdental space under pressure). 2. Contact is slightly too strong but acceptable. Floss or 25 µm metal blade can only be passed through contact with force/pressure. 3. Contact is weak, a 50 µm metal blade can pass through contact area but not a 100 µm blade, or floss passes very easily with only a slight snap effect. There is no indication for removing/repairing restoration and there is no damage to tooth, gingiva or other periodontal structures. There is no cervical caries, inflammation of the gingival papilla through
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.17 | ± 0.58 |
| Flowable Composite | 1.17 | ± 0.58 |
| Bulk Fill Flowable Composite | 1.10 | ± 0.45 |
1. Entirely satisfied with aesthetics and function 2. Satisfied with aesthetics and function 3. Minor criticism but no adverse clinical effects. 4. Desire for improvement (aesthetics / function); Reshaping of anatomic form or refurbishing is possible. 5. Completely dissatisfied and / or adverse effects, incl. pain
| Group | Value | 95% CI |
|---|---|---|
| Universal Composite | 1.0 | ± 0.00 |
| Flowable Composite | 1.0 | ± 0.00 |
| Bulk Fill Flowable Composite | 1.0 | ± 0.00 |
Time frame: Baseline through 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|---|
| death | General disorders | — | — | — |
| Reaction | System | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|---|
| Restoration fracture | General disorders | — | — | — |
| Pulpitis | General disorders | — | — | — |
| Loss of retention | General disorders | — | — | — |
Most-reported serious reactions: death.
Data from ClinicalTrials.gov NCT02889835 adverse events section.
This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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