Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT07627295
Impact of Finishing/Polishing Systems on Ormocer VS Methacrylate Based Bulk Fill Flowable Composite in Class V
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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–35 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This study will evaluate the impact of three different finishing/polishing systems on ormocer versus methacrylate-based bulk-fill flowable composite in Class V restorations on adult patients' anterior teeth. First, investigators will use an ormocer and methacrylate-based bulk-fill flowable composite in Class V restorations in anterior teeth. Then each patient will receive three different finishing/polishing systems. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess the restorations according to the FDI criteria as esthetic properties (A1 surface luster and surface texture; A2 marginal staining; A3 color match), functional (F1 fracture/retention; F2 marginal adaptation), and biological (B1 caries at restoration margin). The results will help dentists choose the most appropriate finishing/polishing systems for Class V restoration cases.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
one-step finishing and polishing system.
Other- 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.
two-step finishing and polishing system.
OtherEach 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.
three-step finishing and polishing system.
OtherEach 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.
Primary outcomes
-
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)
Time frame: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
According to the revised 2023 World Dental Federation (FDI) criteria for,
- 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
- 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
- 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
Study contacts
Contact information is provided by the study sponsor or research team.
Maha Ebaya, PhD
CONTACT
doha m zahran, master
CONTACT
Sponsors and collaborators
Lead sponsor
Mansoura University
Other
Registry information
Official study title
Impact of Finishing/Polishing Systems on Ormocer Versus Methacrylate Based Bulk Fill Flowable Composite in Class V Restorations: Clinical Study and Laboratory Investigations
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jun 4, 2026
- Registry last updated
- Jun 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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