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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cervical Caries

Treatments: Other: Beautifil Flow Plus F00; Other: FIT SA

Study type: Interventional

Funder types: Other

Identifiers

NCT06946134

CairoU PhD protocol for Amira

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Beautifil Flow Plus F00

Active Comparator group

Description:

Conventional flowable giomer restorative material

Treatment:

Other: Beautifil Flow Plus F00

FIT SA

Experimental group

Description:

Self adhesive flowable giomer restorative material

Treatment:

Other: FIT SA