Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT03230604
• Date of registration: 24/07/2017
• Prospective Registration: No
• Primary sponsor: Universidad Nacional Andres Bello
• Public title: Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations
• Scientific title: Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial
• Date of first enrolment: April 1, 2016
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03230604
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Odontologia
• Affiliation: Universidad Andres Bello

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Post Dental Restoration

Caries, Dental

Intervention(s)

Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite

Device: Z 350 Xt Composite

Primary Outcome(s)

Clinical performance restoration [Time Frame: six month, one years, two, three, four and five years]

Secondary ID(s)

DI-1301-16/CB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors