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OpenTrials
Completed

NCT Number: NCT03230604

Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patricio Vildosola Grez

Santiago, Santiago Metropolitan, 7510583, Chile

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite

Device

Restorative cavities one, two and five with material Filtek Bulk Fill Composite

Z 350 Xt Composite

Device

Restorative cavities one, two and five with material Z 350 XT Composite

Primary outcomes

  1. Clinical performance restoration

    Time frame: six month, one years, two, three, four and five years

    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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional Andres Bello

Other

Registry information

Official study title

Clinical Performance of Bulk-fill Resins Composite Restorations on Posterior Tooth of Adults Patients. Randomized Doble-blind Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Jul 26, 2017
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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