Class V RestorationsNCT07627295
Impact of Finishing/Polishing Systems on Ormocer VS Methacrylate Based Bulk Fill Flowable Composite in Class V
A study testing one-step finishing and polishing system., two-step finishing and polishing system. and three-step finishing and polishing system. in people with Class V Restorations, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Restorations
- What is being tested?
- one-step finishing and polishing system., two-step finishing and polishing system. and three-step finishing and polishing system.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Systemic diseases
- Previous or ongoing bleaching procedures
- Smoking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
doha zahran, 0020126336671, dohazahran96@gmail.com
About this study
Official title: Impact of Finishing/Polishing Systems on Ormocer Versus Methacrylate Based Bulk Fill Flowable Composite in Class V Restorations: Clinical Study and Laboratory Investigations
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?
Read the detailed description
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.
- Conditions
- Class V Restorations
- Being tested
- one-step finishing and polishing system., two-step finishing and polishing system., three-step finishing and polishing system.
- Keywords
- Class V restorations;, finishing and polishing;, resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.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 two-step finishing and polishing system.
three-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 three-step finishing and polishing system.
| Study group | Role | What they receive |
|---|---|---|
| Ormocer bulk-fill +one-step finishing/polishing system | Experimental | Class V was restored with an ormocer-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system. Receives: Other: one-step finishing and polishing system. |
| Ormocer bulk-fill + two-step finishing/polishing system | Experimental | Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system. Receives: Other: two-step finishing and polishing system. |
| Ormocer bulk-fill + three-step finishing/polishing system. | Experimental | Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system. Receives: Other: three-step finishing and polishing system. |
| Methacrylate bulk-fill + one-step finishing/polishing system. | Experimental | Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system. Receives: Other: one-step finishing and polishing system. |
| Methacrylate bulk-fill + two-step finishing/polishing system. | Experimental | Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system. Receives: Other: two-step finishing and polishing system. |
| Methacrylate bulk-fill+ three-step finishing/polishing system. | Experimental | Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system. Receives: Other: three-step finishing and polishing system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
- 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
Measured: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start12 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V RestorationsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doha M Zahran, master, Principal investigator, MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.Maha Ebaya, PhD, Study director, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.asmaa abd allah, PhD, Study director, Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura UniversityAbeer El-Embaby, PhD, Study chair, Professor, Conservative Dentistry Department,Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627295
- Sponsor's protocol ID
- MD250825
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Finishing/Polishing Systems on Ormocer Versus Methacrylate Based Bulk Fill Flowable Composite in Class V Restorations: Clinical Study and Laboratory Investigations
- ClinicalTrials.gov ID
- NCT07627295
- Acronym / sponsor ID
- MD250825
- Conditions
- Class V Restorations
- Keywords
- Class V restorations;, finishing and polishing;, resin composite
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ormocer bulk-fill +one-step finishing/polishing system | Experimental | Other: one-step finishing and polishing system.Class 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 | Experimental | Other: two-step finishing and polishing system.Class 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. | Experimental | Other: three-step finishing and polishing system.Class 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. | Experimental | Other: one-step finishing and polishing system.Class 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. | Experimental | Other: two-step finishing and polishing system.Class 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. | Experimental | Other: three-step finishing and polishing system.Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 one-step finishing and polishing system. | Other | Methacrylate bulk-fill + one-step finishing/polishing system., Ormocer bulk-fill +one-step finishing/polishing system |
| 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 two-step finishing and polishing system. | Other | Methacrylate bulk-fill + two-step finishing/polishing system., Ormocer bulk-fill + two-step finishing/polishing system |
| three-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. | Other | Methacrylate bulk-fill+ three-step finishing/polishing system., Ormocer bulk-fill + three-step finishing/polishing system. |
Primary outcome
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, 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doha M Zahran, master principal investigator
MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
Maha Ebaya, PhD study director
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
asmaa abd allah, PhD study director
Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one-step finishing and polishing system., two-step finishing and polishing system. and three-step finishing and polishing system. in people with Class V Restorations, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact doha m zahran, master (00201026336671, dohazahran96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.