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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beautifil Flow Plus F00

    Other intervention

    Conventional flowable giomer restorative material

  • FIT SA after selective enamel etching

    Other intervention

    using self-adhesive giomer restorative material after selective enamel etching

  • FIT SA

    Other intervention

    self-adhesive flowable giomer restorative material

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Beautifil Flow Plus F00Active comparator 1 intervention
Group B: FIT SAExperimental treatment 1 intervention
Group C: FIT SA after selective enamel etchingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention

Modified USPHS criteria

Time frame
18 Months

Secondary outcomes

1

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

Modified USPHS criteria

Time frame
18 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: