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

NCT07575646 | Not Yet Recruiting

• 1 other identifier: Self-Adhesive Giomer
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Caries

Outcome Measures

Primary Outcomes (1)

• Retention

  Modified USPHS criteria

  18 Months

Secondary Outcomes (1)

• Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity

  18 Months

Study Arms (3)

Beautifil Flow Plus F00

ACTIVE COMPARATOR

Conventional flowable giomer restorative material with standard bonding protocol

Other: Beautifil Flow Plus F00

FIT SA

EXPERIMENTAL

Self-adhesive flowable giomer restorative material

Other: FIT SA

FIT SA after selective enamel etching

EXPERIMENTAL

Self-adhesive flowable giomer restorative material after selective enamel etching

Other: FIT SA after selective enamel etching

Interventions

Beautifil Flow Plus F00 OTHER

Conventional flowable giomer restorative material

Beautifil Flow Plus F00

FIT SA after selective enamel etching OTHER

using self-adhesive giomer restorative material after selective enamel etching

FIT SA after selective enamel etching

FIT SA OTHER

self-adhesive flowable giomer restorative material

FIT SA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Root Caries

Interventions

Beautifil Flow Plus F00

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share