NCT06950762

Brief Summary

Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

April 12, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

Giomer based injectable composite

Outcome Measures

Primary Outcomes (1)

  • Marginal discoloration using FDI criteria

    12 Month

Study Arms (2)

Beautifil flow plus x f00

ACTIVE COMPARATOR

Bioactive giomer based injectable resin composite

Procedure: Giomer based injectable composite

G-aenial universal injectable resin composite

ACTIVE COMPARATOR

conventional injectable resin composite

Procedure: Universal injectable resin composite

Interventions

Giomers utilize surface pre-reacted glass (SPRG) technology, which involves an acid-base reaction between fluorine-containing glass particles and polymer-containing acid when exposed to water. This reaction results in the formation of a glass ionomer phase, which is then dispersed throughout the resin. Furthermore, the S-PRG fillers present in giomer materials enable the continuous release and replenishment of fluoride, offering long-lasting protection against the recurrence of caries

Beautifil flow plus x f00

Conventional injectable resin composite

G-aenial universal injectable resin composite

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60 years.
  • Co-operative participants approving to participate in the study.
  • Male or female patients.
  • Medically free participants.
  • Moderate or high caries risk participants.

You may not qualify if:

  • Systemic disease or severe medical complications.
  • Participants with a history of allergy to any component of restorations will be used in the study.
  • Lack of compliance
  • Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Abdelrhman Ahmed Elhariry, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2025

First Posted

April 30, 2025

Study Start

June 10, 2025

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share