N/A
N=159
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02889835 ↗Enrolled (actual)
159
Serious AEs
1.9%
Results posted
Sep 2023
Primary outcome: Primary: Percent Acceptable Restorations — 94.6; 96.4; 92.9 percentage of restorations survived — p=0.686
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supreme Universal Restorative (Device); Supreme Flowable Restorative (Device); Bulk Fill Flowable Restorative (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Acceptable Restorations |
94.6; 96.4; 92.9 | 0.686 |
| SECONDARY Surface Luster |
1.50; 1.39; 1.41 | 0.701 |
| SECONDARY Surface Staining |
1.21; 1.25; 1.19 | 0.812 |
| SECONDARY Color Match |
1.36; 1.32; 1.67 | 0.104 |
| SECONDARY Fracture of Material and Retention |
1.21; 1.07; 1.04 | 0.440 |
| SECONDARY Occlusal Wear - Qualitative |
1.14; 1.07; 1.11 | 0.676 |
| SECONDARY Tooth Integrity |
1.00; 1.00; 1.00 | 1.000 |
| SECONDARY Recurrence of Caries, Erosion, Abfraction |
1.15; 1.11; 1.04 | 0.764 |
| SECONDARY Margin Adaptation |
1.41; 1.21; 1.33 | 0.323 |
| SECONDARY Marginal Staining |
1.33; 1.29; 1.26 | 0.714 |
| SECONDARY Proximal Contact Point |
1.17; 1.17; 1.10 | 0.846 |
| SECONDARY Patient's View |
1.0; 1.0; 1.0 | 1.000 |
| SECONDARY Post-op Sensitivity |
1.04; 1.04; 1.07 | 0.424 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- must have given written informed consent to participate in the trial
- must need at least three posterior dental fillings
- replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
- must be available for the required post-operative follow-up visits
- restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
- Class II restorations must have at least one proximal contact
- restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
- all restorations must Class II with a proximal contact with a natural or artificial tooth
Exclusion Criteria
- have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
- have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
- have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
- are unavailable for long term recall
- cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
- do not meet all inclusion criteria
- present with any systemic or local disorders that contra-indicate the dental procedures included in this study
- have an unstable occlusion
- have severe bruxing or clenching or in need of TMJ related therapy
- have teeth with periapical pathology or expected pulp exposures
- have teeth that are non-vital or that exhibit signs of pulpal pathology
- are pregnant.
Data sourced from ClinicalTrials.gov (NCT02889835). 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.