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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07575646
Enrollment
75
Registered
2026-05-08
Start date
2026-07-01
Completion date
2028-01-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Caries

Brief summary

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.

Detailed description

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.

Interventions

Conventional flowable giomer restorative material

OTHERFIT SA after selective enamel etching

using self-adhesive giomer restorative material after selective enamel etching

OTHERFIT SA

self-adhesive flowable giomer restorative material

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Cervical carious lesions in anterior teeth and premolars 2. Small to moderate class V carious lesion (ICDAS 3 \& 4). 3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis. 4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion criteria

1. Cervical carious lesions in molars. 2. Deep carious defects (close to pulp, less than 1 mm distance). 3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. 4. Non-vital teeth, Fractured or cracked teeth. 5. Endodontically treated teeth. 6. Periodontally affected teeth

Design outcomes

Primary

MeasureTime frameDescription
Retention18 MonthsModified USPHS criteria

Secondary

MeasureTime frameDescription
Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity18 MonthsModified USPHS criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026