NCT05013866

Brief Summary

Bulk Fill" (RBF) composite resins (RC) has been on the market, with the main advantage of being applied in a single layer, faster and easier than a conventional RC. Repair of RC restorations is a validated treatment option in dentistry, which has been shown to increase the longevity of restorations by minimizing tooth damage such as complete replacement. Currently there are no clinical studies that support the actual performance of RBF repair

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

August 4, 2021

Last Update Submit

November 2, 2022

Conditions

Dental Diseases

Keywords

Composite Dental Resin

Outcome Measures

Primary Outcomes (4)

  • Clinical Performance

    Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).

    Baseline

  • Clinical Performance

    Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).

    12 months

  • Clinical Performance

    Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).

    18 months

  • Clinical Performance

    Outcome measure is Clinical performance of composite resin restoration, Device for measurement is FDI System, Unit is Ranking system has 5 scores for each different property. Either restoration is clinically excellent (1), or good (2), or sufficient(3), or unsatisfactory(4), or clinically poor(5).

    24 months

Study Arms (2)

Repair of resin Z350

ACTIVE COMPARATOR

Repair with Z350 on resin composite proximal

Procedure: Repair resin composite proximal

Repair of Tetric Evo Ceram Bulkfill

EXPERIMENTAL

Repair with Tetric Evo Ceram on resin composite proximal

Procedure: Repair resin composite proximal

Interventions

Repair resin composite proximalPROCEDURE

Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin

Repair of Tetric Evo Ceram BulkfillRepair of resin Z350

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 years,
  • healthy
  • high cariogenic risk,
  • Vital molars and premolars,
  • Natural antagonist and proximal
  • Indication of repair in the proximal with depth\> 2mm.

You may not qualify if:

  • Patients has xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients -inability to perform hygiene
  • pregnant women
  • severe bruxism
  • Prosthesis
  • Not absolute isolation
  • Tooth fracture and / or restoration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricio Vildosola Grez

Santiago, Santiago Metropolitan, 7510583, Chile

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Patricio Vildosola

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 19, 2021

Study Start

August 15, 2016

Primary Completion

September 1, 2017

Study Completion

September 30, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)