Dental Caries
Conditions
Keywords
small Class I, molar and premolar, low stress flowable composite, adult, Restoration, small caries lesions
Brief summary
Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth. Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.
Detailed description
The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.
Interventions
DEVICEFlowable composite
Restoration of small Class V and I cavities in molar and premolar teeth
DEVICEConventional composite restorative
Restoration of small Class V and I cavities in molar and premolar teeth
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years or older * must give written consent * be in good general health * be available for required follow-up visits * have at least 28 teeth
Exclusion criteria
* has rampant, uncontrolled caries * has advanced, untreated periodontal disease * heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco * has systemic or local disorders that contra-indicate the dental procedures needed in this study * has evidence of xerostomia * has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy * is pregnant at time of screening or tooth restoration * has known sensitivity to acrylates or related materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance by Cvar & Ryge Scores | baseline, 6, 12 and 24 months | Clinical performance reported on 6 parameters as the % of teeth with perfect scores (A rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present). |
| Clinical Performance by VAS (Pain Scale) | baseline, 6, 12 and 24 months | Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable.
Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth
Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 52 years |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Clinical Performance by Cvar & Ryge Scores
Clinical performance reported on 6 parameters as the % of teeth with perfect scores (A rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
Time frame: baseline, 6, 12 and 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Surface Integrity Baseline | 98.3 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 12 Mo | 96.4 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Color match form 6 Mo | 96.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Color match baseline | 96.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic baseline | 100.0 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaptation baseline | 96.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration Baseline | 98.3 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaptation 6 Mo | 93.2 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration 6 Mo | 96.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Surface integrity 6 Mo | 96.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Secondar carries Baseline | 100. percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 6 Mo | 100. percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Color match 12 Mo | 92.7 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaption 12 Mo | 81.8 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration 12 Mo | 90.9 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Surface Integrity 12 Mo | 92.7 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 12 Mo | 94.5 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 24 Mo | 89.8 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Color match 24 Mo | 85.7 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaption 24 Mo | 83.7 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloraton 24 Mo | 85.7 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Surface integrity 24 Mo | 79.6 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 24 Mo | 93.9 percent of teeth |
| Flowable Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 6 Mo | 100. percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 24 Mo | 94 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Color match 12 Mo | 83.9 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 12 Mo | 94.6 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Color match 24 Mo | 78.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaption 12 Mo | 78.6 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Color match baseline | 88.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Surface integrity 24 Mo | 78.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic baseline | 100.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration 12 Mo | 90.1 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaptation baseline | 98.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaption 24 Mo | 80.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration Baseline | 98.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 6 Mo | 96.7 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Color match form 6 Mo | 91.7 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Surface Integrity 12 Mo | 78.6 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal adaptation 6 Mo | 88.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 6 Mo | 98.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloration 6 Mo | 95.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Secondary caries 12 Mo | 94.6 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Surface Integrity Baseline | 96.7 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Marginal discoloraton 24 Mo | 80.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Secondar carries Baseline | 98.3 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Surface integrity 6 Mo | 90.0 percent of teeth |
| Conventional Composite | Clinical Performance by Cvar & Ryge Scores | Anatomic form 24 Mo | 86.0 percent of teeth |
Comparison: null hypothesis no difference in anatomic formp-value: 0.8ANOVA
Comparison: null hypothesis no difference in margin adaptationp-value: 0.89ANOVA
Comparison: null hypothesis no difference in margin discolorationp-value: 0.79ANOVA
Comparison: null hypothesis no difference in surface integrityp-value: 0.18ANOVA
Comparison: null hypothesis no difference in secondary cariesp-value: 0.66ANOVA
Primary
Clinical Performance by VAS (Pain Scale)
Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Time frame: baseline, 6, 12 and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold baseline | 1.6 units on a scale | Standard Deviation 1.6 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitivity to biting baseline | 0.5 units on a scale | Standard Deviation 0.6 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 6 Mo | 1.5 units on a scale | Standard Deviation 1.4 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 6 Mo | 0.6 units on a scale | Standard Deviation 0.7 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 12 Mo | 2.1 units on a scale | Standard Deviation 2.2 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 12 Mo | 0.3 units on a scale | Standard Deviation 0.5 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 24 Mo | 1.5 units on a scale | Standard Deviation 1.9 |
| Flowable Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 24 Mo | 0.2 units on a scale | Standard Deviation 0.5 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 24 Mo | 0.1 units on a scale | Standard Deviation 0.3 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold baseline | 1.6 units on a scale | Standard Deviation 2 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 12 Mo | 1.7 units on a scale | Standard Deviation 1.7 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitivity to biting baseline | 0.7 units on a scale | Standard Deviation 0.7 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 24 Mo | 1.0 units on a scale | Standard Deviation 1.3 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to cold 6 Mo | 1.8 units on a scale | Standard Deviation 1.7 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 12 Mo | 0.3 units on a scale | Standard Deviation 0.5 |
| Conventional Composite | Clinical Performance by VAS (Pain Scale) | sensitiity to biting 6 Mo | 0.8 units on a scale | Standard Deviation 0.8 |
Comparison: null hypothesis no difference in sensitivity to coldp-value: 0.522ANOVA
Comparison: null hypothesis no difference in biting pressurep-value: 0.449Chi-squared