NCT02858947

Brief Summary

The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

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

March 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

3.6 years

First QC Date

July 26, 2016

Last Update Submit

August 3, 2016

Conditions

Dental Caries

Keywords

composite resinbulk-fillteeth endodontically-treated

Outcome Measures

Primary Outcomes (1)

  • Clinical performance evaluation of different composite resin restorations with USPHS criteria

    Every year in three years period

    three years

Study Arms (2)

Aelite Flo

ACTIVE COMPARATOR

Microhybrid flowable composite

Procedure: Aelite Flo

x-tra base

ACTIVE COMPARATOR

Bulk-fill flowable composite

Procedure: x-tra base

Interventions

Aelite FloPROCEDURE

Microhybrid flowable composite

Also known as: 1000006652
Aelite Flo
x-tra basePROCEDURE

Bulk-fill flowable composite

Also known as: 1145403
x-tra base

Eligibility Criteria

Age19 Years - 41 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Permanent premolars and molars without any restorations were included in the study. Every tooth included in the study had neighboring teeth and were in occlusion to antagonistic teeth.

You may not qualify if:

  • Patients were excluded who needed indirect restorations due to significant loss of tooth structure, known allergies to product ingredients, had poor oral hygiene and a history of bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesTooth, Nonvital

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Pulp Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 8, 2016

Study Start

March 1, 2011

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share