Impact of Finishing/Polishing Systems on Ormocer VS Methacrylate Based Bulk Fill Flowable Composite in Class V
1 other identifier
interventional
25
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate and compare. Impact of finishing/polishing systems on ormocer versus methacrylate-based bulk-fill flowable composite in Class V restorations: The main question it aims to answer is the following: Are there any differences between finishing/polishing systems on Ormocer versus methacrylate-based bulk-fill flowable composite?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2026
CompletedStudy Start
First participant enrolled
May 12, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
June 4, 2026
May 1, 2026
2 years
May 6, 2026
May 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)
According to the revised 2023 World Dental Federation (FDI) criteria for, 1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. Unit of Measure: FDI score 2. Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. Unit of Measure: FDI score 3. Biological properties Restoration assessment of B1 (caries at restoration margin) according to the revised 2023 FDI criteria. Lower scores indicate better performance. Unit of Measure: FDI
Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
Study Arms (6)
Ormocer bulk-fill +one-step finishing/polishing system
EXPERIMENTALClass V was restored with an ormocer-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
Ormocer bulk-fill + two-step finishing/polishing system
EXPERIMENTALClass V restored with an ormocer-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
Ormocer bulk-fill + three-step finishing/polishing system.
EXPERIMENTALClass V restored with an ormocer-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
Methacrylate bulk-fill + one-step finishing/polishing system.
EXPERIMENTALClass V restored with methacrylate-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
Methacrylate bulk-fill + two-step finishing/polishing system.
EXPERIMENTALClass V restored with methacrylate-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
Methacrylate bulk-fill+ three-step finishing/polishing system.
EXPERIMENTALClass V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
Interventions
• Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a one-step finishing and polishing system.
Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a two-step finishing and polishing system.
Each Class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each Class V restoration will be subjected to a three-step finishing and polishing system.
Eligibility Criteria
You may qualify if:
- Three pairs of buccal cervical supragingival carious lesions in anterior teeth
- Complete and normal occlusion
- Good oral hygiene
- Willingness to attend follow-up and recall visits for 2 years
You may not qualify if:
- Teeth requiring direct pulp capping
- Poor oral hygiene or failure to complete the oral hygiene phase
- Chronic periodontitis
- Pulpitis or non-vital teeth
- Current orthodontic treatment
- Presence of parafunctional habits
- Systemic diseases
- Previous or ongoing bleaching procedures
- Smoking patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Doha M Zahran, master
MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
- STUDY DIRECTOR
Maha Ebaya, PhD
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
- STUDY DIRECTOR
asmaa abd allah, PhD
Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University
- STUDY CHAIR
Abeer El-Embaby, PhD
Professor, Conservative Dentistry Department,Faculty of Dentistry, Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2026
First Posted
June 4, 2026
Study Start
May 12, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
June 4, 2026
Record last verified: 2026-05