Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial

The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Caries; Caries, Dental
• Intervention / Treatment: Other: Beautiful Flow Plus X; Other: Dentsply Nanohybrid flowable composite

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elmoaty, Dentist; Phone Number: +201555717662; Email: ahmedelmoety96@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults patients (20-50)
• Good oral hygiene (plaque index 0 or 1 )
• Patient approving to participate in the study
• Absence of parafunctional habits and/or bruxism

Exclusion Criteria:

• Patients with known allergic or adverse reaction to the tested materials.
• Systematic disease that may affect participation.
• Xerostomic patients.
• Bad oral hygiene (plaque index 2 or 3 )
• Heavy smokers
• Patients undergoing or will start orthodontic treatment
• Patients with removable prothesis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bioactive Giomer Material	Other: Beautiful Flow Plus X; Shofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites
Active Comparator: Nanohybrid resin composite	Other: Dentsply Nanohybrid flowable composite; a conventional nano hybrid flowable composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent caries	Yes: no evidence of caries continuous along the margin; No: caries evident continuous with the margin of restoration	1 week, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative sensitivity	No: Absent; Yes: Present	1 week, 6 months and 12 months
Fracture of the restoration	Restoration is intact and fully retained.; Restoration is partially retained with some portion of the restoration still intact.; Restoration is completely missing	1 week, 6 months and 12 months
Bleeding on probing	0 Healthy gums; 1 Bleeding on probing; 2 periodontal problem with bone loss	1 week, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Future University in Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: Ahmed elmoety protocol

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No