An interventional study of Supreme Universal Restorative and Supreme Flowable Restorative in Dental Caries, sponsored by Solventum US LLC. Completed at 1 site in United States. Open to participants aged 19 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Solventum US LLC · Not applicable, Interventional, and Treatment
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.
Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 53 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Supreme Universal Restorative
Device: Supreme Universal Restorative
Supreme Flowable Restorative
Device: Supreme Flowable Restorative
Bulk Fill Flowable Restorative
Device: Bulk Fill Flowable Restorative
Percent Acceptable Restorations
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
Time frame: 36 Months
Surface Luster
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.
Time frame: 36 Month
Surface Staining
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 needs to be replaced.
Time frame: 36 Month
Color Match
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 clinically unsatisfactory. The restoration displays an unacceptable alteration in colour and/or translucency. Restoration needs replacement.
Time frame: 36 Month
Fracture of Material and Retention
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).
Time frame: 36 Month
Occlusal Wear - Qualitative
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.
Time frame: 36 Month
Tooth Integrity
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
Time frame: 36 Month
Recurrence of Caries, Erosion, Abfraction
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
Time frame: 36 Months
Margin Adaptation
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 result in exposure of dentine or base. Repair necessary for prophylactic reasons. 5. Generalized gap larger than 250 µm or restoration is loose but in situ, replacement necessary or large fractures at margins and loss of material is too extensive to be repaired.
Time frame: 36 Months
Marginal Staining
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.
Time frame: 36 Months
Proximal Contact Point
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 food impaction, or pocket formation. 4. Contact is weak and a 100 µm metal blade can easily pass through. In addition there are signs of damage to tooth (i.e. cervical caries,). Repair is necessary. 5. Contact is weak allowing damage due to food impaction and demonstrating pain/gingivitis requires immediate intervention. Repair is not feasible and replacement is necessary.
Time frame: 36 Months
Patient's View
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
Time frame: 36 Months
Post-op Sensitivity
1. No postoperative hypersensitivity. Normal pulp vitality response. 2. Postoperative hypersensitivity of short duration (less than one week) and no longer present at the baseline assessment. Pulp vitality response normal at baseline assessment (one week after placement). 3. Intense postoperative hypersensitivity of duration greater than one week but less than six-months. 4. Persistent postoperative hypersensitivity. Response to cold stimulus is markedly premature/strong and major intervention is necessary; or there is extremely delayed/weak and unclear or negative sensitivity. Sensitivity level is significantly different from the situation prior to treatment. 5. Negative sensitivity recorded at recall visit despite positive pulp response at baseline, or severe pain is noted. Removal of restoration and immediate root canal treatment is required or the tooth must be extracted.
Time frame: 36 Months
53 subjects were evaluated at baseline (3 subjects with 2 sets of restorations). "Number Started" will be greater than the Protocol Enrollment and cannot be revised, however, this is acceptable for split-person studies.
| Milestone | Universal Composite | Flowable Composite | Bulk-fill Composite |
|---|---|---|---|
| Started | 53 | 53 | 53 |
| Completed | 35 | 35 | 35 |
| Not completed | 18 | 18 | 18 |
| Withdrew: Lost to follow-up | 13 | 13 | 13 |
| Withdrew: Withdrawal by subject | 2 | 2 | 2 |
| Withdrew: Protocol violation | 1 | 1 | 1 |
| Withdrew: Exclusion criteria -change in oral status | 1 | 1 | 1 |
| Withdrew: Death | 1 | 1 | 1 |
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
| percentage of restorations survived | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Percent Acceptable Restorations | 94.6 | 96.4 | 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.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Surface Luster | 1.50 ± 0.58 | 1.39 ± 0.57 | 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 needs to be replaced.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Surface Staining | 1.21 ± 0.50 | 1.25 ± 0.44 | 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 clinically unsatisfactory. The restoration displays an unacceptable alteration in colour and/or translucency. Restoration needs replacement.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Color Match | 1.36 ± 0.49 | 1.32 ± 0.48 | 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).
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Fracture of Material and Retention | 1.21 ± 0.79 | 1.07 ± 0.38 | 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.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Occlusal Wear - Qualitative | 1.14 ± 0.36 | 1.07 ± 0.26 | 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
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Tooth Integrity | 1.00 ± 0 | 1.00 ± 0 | 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
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Recurrence of Caries, Erosion, Abfraction | 1.15 ± 0.60 | 1.11 ± 0.57 | 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 result in exposure of dentine or base. Repair necessary for prophylactic reasons. 5. Generalized gap larger than 250 µm or restoration is loose but in situ, replacement necessary or large fractures at margins and loss of material is too extensive to be repaired.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Margin Adaptation | 1.41 ± 0.57 | 1.21 ± 0.42 | 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.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Marginal Staining | 1.33 ± 0.59 | 1.29 ± 0.53 | 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 food impaction, or pocket formation. 4. Contact is weak and a 100 µm metal blade can easily pass through. In addition there are signs of damage to tooth (i.e. cervical caries,). Repair is necessary. 5. Contact is weak allowing damage due to food impaction and demonstrating pain/gingivitis requires immediate intervention. Repair is not feasible and replacement is necessary.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Proximal Contact Point | 1.17 ± 0.58 | 1.17 ± 0.58 | 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
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Patient's View | 1.0 ± 0.00 | 1.0 ± 0.00 | 1.0 ± 0.00 |
1. No postoperative hypersensitivity. Normal pulp vitality response. 2. Postoperative hypersensitivity of short duration (less than one week) and no longer present at the baseline assessment. Pulp vitality response normal at baseline assessment (one week after placement). 3. Intense postoperative hypersensitivity of duration greater than one week but less than six-months. 4. Persistent postoperative hypersensitivity. Response to cold stimulus is markedly premature/strong and major intervention is necessary; or there is extremely delayed/weak and unclear or negative sensitivity. Sensitivity level is significantly different from the situation prior to treatment. 5. Negative sensitivity recorded at recall visit despite positive pulp response at baseline, or severe pain is noted. Removal of restoration and immediate root canal treatment is required or the tooth must be extracted.
| units on a scale | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Post-op Sensitivity | 1.04 ± 0.19 | 1.04 ± 0.09 | 1.07 ± 0.27 |
Collected over Baseline through 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Universal Composite | 1/53 (1.9%) | 1/53 (1.9%) | 3/53 (5.7%) |
| Flowable Composite | 1/53 (1.9%) | 1/53 (1.9%) | 2/53 (3.8%) |
| Bulk Fill Flowable Composite | 1/53 (1.9%) | 1/53 (1.9%) | 4/53 (7.5%) |
| Event | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| deathGeneral disorders | 1/53 | 1/53 | 1/53 |
| Event | Universal Composite | Flowable Composite | Bulk Fill Flowable Composite |
|---|---|---|---|
| Restoration fractureGeneral disorders | 2/53 | 2/53 | 2/53 |
| PulpitisGeneral disorders | 0/53 | 0/53 | 2/53 |
| Loss of retentionGeneral disorders | 1/53 | 0/53 | 0/53 |
A total of 53 patients were enrolled. Each patient received in different teeth, one restoration of each intervention except for 3 patients who received two restorations of each intervention for a total of 56 teeth per intervention.
| Age, Categorical(Participants) | Universal Composite, Flowable Composite, Bulk Fill Flowable Composite |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 44 |
| >=65 years | 9 |
| Sex: Female, Male(Participants) | Universal Composite, Flowable Composite, Bulk Fill Flowable Composite |
|---|---|
| Female | 13 |
| Male | 40 |
| Race and Ethnicity Not Collected(Participants) | Universal Composite, Flowable Composite, Bulk Fill Flowable Composite |
|---|
| Region of Enrollment(participants) | Universal Composite, Flowable Composite, Bulk Fill Flowable Composite |
|---|---|
| United States | 53 |
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Solventum US LLC