CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

NCT ID: NCT05559333

Last Updated: 2022-09-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2022-03-24

Brief Summary

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

The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.

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.

Class I Dental Caries

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

randomized-split mouth clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

zirconomer

zirconia reinforced glass ionomer cement

Group Type ACTIVE_COMPARATOR

class I restoration placement

Intervention Type PROCEDURE

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Equia Fil

High viscosity glass ionomer cement

Group Type ACTIVE_COMPARATOR

class I restoration placement

Intervention Type PROCEDURE

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

glass carbomer

glass ionomer cement containing nano sized- carbonized particles.

Group Type ACTIVE_COMPARATOR

class I restoration placement

Intervention Type PROCEDURE

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Tetric-evo ceram bulk fill

Bulk fill composite resin

Group Type ACTIVE_COMPARATOR

class I restoration placement

Intervention Type PROCEDURE

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Interventions

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

class I restoration placement

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

Exclusion Criteria

* patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.
Minimum Eligible Age

18 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.

Ece Meral

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hacettepe University

Ankara, Altındağ, 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.

KA-17057

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
Clinical Evaluation of a Bioactive Material
NCT04825379 ACTIVE_NOT_RECRUITING NA