Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 12/9/2018 |
| Start Date: | March 22, 2016 |
| End Date: | January 2020 |
"Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"
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.
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 (direct and indirect).
preparations of adult patients, evaluate the resin composite restorations at baseline, 6
months, 1 year, 2 and 3 years using specific criteria (direct and indirect).
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.
We found this trial at
1
site
1919 7th Avenue South
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Phone: 205-996-5747
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