N/A
N=60
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01369108 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Clinical Performance by Cvar & Ryge Scores — 96.6; 88.3; 100.0; 100.0 percent of teeth — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flowable composite (Device); Conventional composite restorative (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Performance by Cvar & Ryge Scores |
96.6; 88.3; 100.0; 100.0; 96.6; 98.3 | 0.8 |
| PRIMARY Clinical Performance by VAS (Pain Scale) |
1.6; 1.6; 0.5; 0.7; 1.5; 1.8 | 0.522 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01369108). 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.