NCT02889835CompletedNot Applicable
"Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Solventum US LLC
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Percent Acceptable Restorations
Study Overview
Brief 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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Universal Composite
Active Comparator
Supreme Universal Restorative
Intervention: Supreme Universal Restorative (Device)
Flowable Composite
Experimental
Supreme Flowable Restorative
Intervention: Supreme Flowable Restorative (Device)
Bulk Fill Flowable Composite
Experimental
Bulk Fill Flowable Restorative
Intervention: Bulk Fill Flowable Restorative (Device)
Outcomes
Primary Outcomes
Percent Acceptable Restorations
Time Frame: 36 Months
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
Secondary Outcomes
- Surface Luster(36 Month)
- Tooth Integrity(36 Month)
- Patient's View(36 Months)
- Surface Staining(36 Month)
- Color Match(36 Month)
- Marginal Staining(36 Months)
- Proximal Contact Point(36 Months)
- Occlusal Wear - Qualitative(36 Month)
- Recurrence of Caries, Erosion, Abfraction(36 Months)
- Margin Adaptation(36 Months)
- Fracture of Material and Retention(36 Month)
- Post-op Sensitivity(36 Months)
Investigators
Study Sites (1)
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