Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

NCT03230604 | Completed DMC

• 1 other identifier: DI-1301-16/CB
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Dental Restoration; Caries, Dental

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bulk-Fill composite Class I, II and V cavities

ACTIVE COMPARATOR

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; Device: Z 350 Xt Composite

Z 350 xt Composite

ACTIVE COMPARATOR

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

Device: Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite; Device: Z 350 Xt Composite

Interventions

Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite DEVICE

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

Bulk-Fill composite Class I, II and V cavities; Z 350 xt Composite

Z 350 Xt Composite DEVICE

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

Bulk-Fill composite Class I, II and V cavities; Z 350 xt Composite

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Patricio Vildosola Grez

Santiago, Santiago Metropolitan, 7510583, Chile

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Odontologia

  Universidad Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: April 1, 2016
• Primary Completion: July 24, 2017
• Study Completion: December 1, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

CL (1)