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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Caries
• Intervention / Treatment: Other: Beautifil Flow Plus F00; Other: FIT SA; Other: FIT SA after selective enamel etching

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beautifil Flow Plus F00; Conventional flowable giomer restorative material with standard bonding protocol	Other: Beautifil Flow Plus F00; Conventional flowable giomer restorative material
Experimental: FIT SA; Self-adhesive flowable giomer restorative material	Other: FIT SA; self-adhesive flowable giomer restorative material
Experimental: FIT SA after selective enamel etching; Self-adhesive flowable giomer restorative material after selective enamel etching	Other: FIT SA after selective enamel etching; using self-adhesive giomer restorative material after selective enamel etching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Modified USPHS criteria	18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity	Modified USPHS criteria	18 Months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Root Caries; Beautifil Flow Plus F00
• Other Study ID Numbers: Self-Adhesive Giomer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No