Caries, Dental Clinical Trial
Official title:
Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
Verified date | May 2022 |
Source | Universidad Nacional Andres Bello |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.
Status | Completed |
Enrollment | 142 |
Est. completion date | December 1, 2021 |
Est. primary completion date | July 24, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - must have given written informed consent to participate in the trial - need at least three posterior restorations - must be available for the required post-operative follow-up visits - have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips - At least one occlusal and proximal contact on a natural tooth - Cavities depth > 2 mm in cervico-occlusal 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 - have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients - chronic periodontitis - present with any systemic or local disorders that contra-indicate the dental procedures included in this study - an unstable occlusion - severe bruxing - teeth with periapical pathology or expected pulp exposures - are pregnant. - Endodontically treated teeth |
Country | Name | City | State |
---|---|---|---|
Chile | Patricio Vildosola Grez | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Universidad Nacional Andres Bello |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance restoration | Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI criteria , Unit is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor. | six month, one years, two, three, four and five years |
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