Clinical Comparison of Bulk-fill and Incremental Composite

NCT ID: NCT04685954

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin \[Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)\] and an incremental posterior composite resin \[Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bulk-Fill

Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)

Group Type EXPERIMENTAL

Filtek Bulk-Fill Posterior

Intervention Type DEVICE

Bulk-fill restorative composite

Incremental

Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)

Group Type EXPERIMENTAL

Filtek Ultimate Universal

Intervention Type DEVICE

Incremental restorative composite

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Filtek Bulk-Fill Posterior

Bulk-fill restorative composite

Intervention Type DEVICE

Filtek Ultimate Universal

Incremental restorative composite

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria

* poor gingival health
* adverse medical history
* potential behavioral problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Fatma Dilşad Öz

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bulk-incremental

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Performance of Different Resin Cements
NCT04694690 ACTIVE_NOT_RECRUITING NA