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NCT Number: NCT06946134

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial

The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.

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Key information

Conditions

Cervical Caries Dental Caries Root Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cervical carious lesions in anterior teeth and premolars
  • Small to moderate class V carious lesion (ICDAS 3 & 4).
  • Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion criteria

  • Cervical carious lesions in molars.
  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  • Non-vital teeth, Fractured or cracked teeth.
  • Endodontically treated teeth.
  • Periodontally affected teeth

Treatment and study plan

FIT SA

Other

self-adhesive flowable giomer restorative material

Beautifil Flow Plus F00

Other

Conventional flowable giomer restorative material

Primary outcomes

  1. Clinical Performance

    Time frame: 18 months

    Clinical Performance using Modified USPHS criteria

Study contacts

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

Amira Nabil El-Gaaly, PhD degree

CONTACT

[email protected]

00201099872098

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

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.

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