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NCT Number: NCT06543680

Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems

To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry mansoura university

Al Mansurah, Dakahliya, 35516, Egypt

Location status: Recruiting

About this study

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of 35 patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on 105 Class V restorations.A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from may 2023 to may 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.

Clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. It will be designed depending on modified USPHS criteria and FDI criteria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria will be fair oral hygiene patients with 30-60 years. Patients with at least three similarly sized non-carious cervical lesions (NCCLs) in vital teeth that need for restoration and depth of NCCLs will be 1-3 mm with at least 50% of margins without enamel.

Exclusion criteria

  • Exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.

Treatment and study plan

Dental restoration

Other

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Primary outcomes

  1. Percentage of aesthetic, functional and biological properties for each group

    Time frame: 2 years after restoration

    Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation and USPHS parameters for each restorative system group

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer E Elembaby, Professor

CONTACT

[email protected]

01000033812

Mohamed E Hamouda, Assistant Lecturer

CONTACT

[email protected]

01018357630

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems: Two Years Randomized Clinical Study in Class ᴠ

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.