Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

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

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.

Study Overview

• Status: Completed
• Conditions: Caries, Dental; Post Dental Restoration
• Intervention / Treatment: Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Device: Z 350 Xt Composite

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

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7510583
      • Patricio Vildosola Grez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bulk-Fill composite Class I, II and V cavities; Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V	Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Restorative cavities one, two and five with material Filtek Bulk Fill Composite; Device: Z 350 Xt Composite; Restorative cavities one, two and five with material Z 350 XT Composite
Active Comparator: Z 350 xt Composite; Restorative with Z 350 xt composite in class I, II and V	Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Restorative cavities one, two and five with material Filtek Bulk Fill Composite; Device: Z 350 Xt Composite; Restorative cavities one, two and five with material Z 350 XT Composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad Nacional Andres Bello
• Investigators: Principal Investigator: Odontologia, Universidad Andrés Bello

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 24, 2017
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Z 350
• Other Study ID Numbers: DI-1301-16/CB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No