18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 34
- Primary Endpoint
- Clinical Performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Beautifil Flow Plus F00
Conventional flowable giomer restorative material
Intervention: Beautifil Flow Plus F00 (Other)
FIT SA
Self adhesive flowable giomer restorative material
Intervention: FIT SA (Other)
Outcomes
Primary Outcomes
Clinical Performance
Time Frame: 18 months
Clinical Performance using Modified USPHS criteria
Secondary Outcomes
No secondary outcomes reported
Investigators
Amera Nabel
master holder
Cairo University