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Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

Primary Purpose

Post Dental Restoration, Caries, Dental

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite
Z 350 Xt Composite
Sponsored by
Universidad Nacional Andres Bello
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Dental Restoration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Patricio Vildosola Grez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bulk-Fill composite Class I, II and V cavities

Z 350 xt Composite

Arm Description

Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V

Restorative with Z 350 xt composite in class I, II and V

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 24, 2017
Last Updated
May 16, 2022
Sponsor
Universidad Nacional Andres Bello
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1. Study Identification

Unique Protocol Identification Number
NCT03230604
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 24, 2017 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Andres Bello

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Dental Restoration, Caries, Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bulk-Fill composite Class I, II and V cavities
Arm Type
Active Comparator
Arm Description
Restorative with Filtek Bulkfill composite in class I, II and V Restorative with Tetric N Ceram composite in class I, II and V
Arm Title
Z 350 xt Composite
Arm Type
Active Comparator
Arm Description
Restorative with Z 350 xt composite in class I, II and V
Intervention Type
Device
Intervention Name(s)
Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite
Intervention Description
Restorative cavities one, two and five with material Filtek Bulk Fill Composite
Intervention Type
Device
Intervention Name(s)
Z 350 Xt Composite
Intervention Description
Restorative cavities one, two and five with material Z 350 XT Composite
Primary Outcome Measure Information:
Title
Clinical performance restoration
Description
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.
Time Frame
six month, one years, two, three, four and five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odontologia
Organizational Affiliation
Universidad Andres Bello
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patricio Vildosola Grez
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510583
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

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