Clinical Evaluation of Class II Restorations

NCT ID: NCT06346756

Last Updated: 2024-06-05

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-07-15

Brief Summary

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

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05).

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.

Dental Caries Dental Caries Class II

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

DOUBLE

Participants Outcome Assessors

Study Groups

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

G-aenial A'CHORD universal composite

Group Type EXPERIMENTAL

Treatment of dental caries.

Intervention Type OTHER

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Tetric Prime universal composite

Group Type EXPERIMENTAL

Treatment of dental caries.

Intervention Type OTHER

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Filtek Ultimate universal composite

Group Type EXPERIMENTAL

Treatment of dental caries.

Intervention Type OTHER

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

G-aenial Universal Injectable composite

Group Type EXPERIMENTAL

Treatment of dental caries.

Intervention Type OTHER

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Interventions

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

Treatment of dental caries.

The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. proximal caries that are similar in size to premolar and molar teeth
4. vital teeth
5. teeth in contact with the opposing tooth and subjected to normal occlusal forces
6. attend follow-up appointments

Exclusion Criteria

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. exposure of the pulp during cavity preparation
7. systemically unhealthy
8. pregnant and lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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

Merve Gurses

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Merve Gürses

Role: PRINCIPAL_INVESTIGATOR

Selcuk University, Faculty of Dentistry

Locations

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

Selcuk University, Faculty of Dentistry

Konya, , 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.

SelcukA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Clinical Comparison of Restorative Materials
NCT06637605 ACTIVE_NOT_RECRUITING