Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

Sponsor

Universidad Nacional Andres Bello (Other)

Overall Status

Completed

CT.gov ID

NCT03230604

Collaborator

(none)

142

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Dental Restoration Caries, Dental	Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite Device: Z 350 Xt Composite	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 cavitiesIntervention: 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:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jul 24, 2017

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical performance restoration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Patricio Vildosola Grez	Santiago	Metropolitana	Chile	7510583

Sponsors and Collaborators

Universidad Nacional Andres Bello

Investigators

Principal Investigator: Odontologia, Universidad Andres Bello

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patricio Vildosola Grez, Associate Professor, Universidad Nacional Andres Bello

ClinicalTrials.gov Identifier:

NCT03230604

Other Study ID Numbers:

DI-1301-16/CB

First Posted:

Jul 26, 2017

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Z 350

Study Results

No Results Posted as of May 18, 2022