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NCT Number: NCT07575646

Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching

This randomized clinical trial is to evaluate the clinical performance of the self-adhesive flowable Giomer with and without selective enamel etching compared to flowable Giomer using standard bonding protocol in class V cavity restorations over a period of 18 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Self-adhesive flowable restorative materials have been introduced to simplify clinical procedures by eliminating the need for separate bonding steps. These materials are designed to combine adhesive and restorative functions in a single application, which may reduce technique sensitivity and chairside time. However, the bond strength of self-adhesive materials to enamel and dentin remains a concern, particularly in cervical lesions where reliable adhesion is critical for long-term clinical success Selective enamel etching has been suggested as a technique to improve enamel bonding when using self-adhesive or self-etch materials, as it enhances micromechanical retention without adversely affecting dentin bonding. Previous studies have reported that additional enamel etching may improve marginal adaptation and retention, while preserving the simplified clinical procedure of self-adhesive systems. Nevertheless, the clinical effectiveness of self-adhesive Giomer materials with and without selective enamel etching in high caries-risk patients has not been sufficiently investigated.

Therefore, randomized clinical trials evaluating the performance of these materials in cervical carious lesions are required to determine the most reliable restorative approach in patients with increased susceptibility to caries.

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

Beautifil Flow Plus F00

Other

Conventional flowable giomer restorative material

FIT SA after selective enamel etching

Other

using self-adhesive giomer restorative material after selective enamel etching

FIT SA

Other

self-adhesive flowable giomer restorative material

Primary outcomes

  1. Retention

    Time frame: 18 Months

    Modified USPHS criteria

Secondary outcomes

  1. Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity

    Time frame: 18 Months

    Modified USPHS criteria

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching Versus Flowable Giomer Using Standard Bonding Protocol in Carious Cervical Lesions: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 8, 2026
Registry last updated
May 8, 2026

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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