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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06946134
Enrollment
34
Registered
2025-04-27
Start date
2025-09-30
Completion date
2027-02-28
Last updated
2025-04-27

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

Conditions

Cervical Caries

Keywords

Self-adhesive giomer, Bioactive, Randomized clinical trial., USPHS criteria, Carious cervical lesion, Class V, Clinical performance, FIT SA, Beautifil Flow Plus

Brief summary

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

Detailed description

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.

Interventions

OTHERFIT SA

self-adhesive flowable giomer restorative material

Conventional flowable giomer restorative material

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, 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
Clinical Performance18 monthsClinical Performance using Modified USPHS criteria

Contacts

Primary ContactAmira Nabil El-Gaaly, PhD degree
amera.elgaaly@dentistry.cu.edu.eg00201099872098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026