Clinical trial NCT03230604: Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations
Official title: Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Dental Restoration
Caries, Dental
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention: Bulk full composite (3M) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities

Intervention:Bulk full composite (Ivoclar-Vivadent) bulk fill composite in posterior class one cavities bulk fill composite in posterior class two cavities bulk fill composite in posterior class five cavities Other: bulk fill composite Intervention Control: Nano resin composite (K Z350 xt) Restoration in class one cavities Restoration in class Two cavities Restoration in class five cavities
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A patients with 3 caries lesions class one either two or five will be divided into 3 groups , cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (Bluephase Style Ivoclar-Vivadent), with an energy 1,100 mW/cm² (±50 mw/cm²) and others group of cavities will be restored by bulk fill composite (3M ESPE) and other bulk fill composite ( IVOCLAR-VIVADENT) as one increment then will be cured as directed by the manufacturer with the light curing unit.

The study will investigate the clinical performance and efficacy of a bulk-filled composite resin restorative material for a period of 5 years

Eligibility criteria: 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

Primary outcomes:
measure: Clinical performance restoration
timeFrame: six month, one years, two, three, four and five years
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Patricio Vildosola Grez
state: Metropolitana
Study officials:
affiliation: Universidad Andres Bello
name: Odontologia
role: PRINCIPAL_INVESTIGATOR
References: