Esthetic RestorationsNCT06732115
Effect of One-step Versus Multistep Polishing Protocol on Class IV Composite Restorations.
A study testing One-step polishing system with nanohybrid resin composite restorations. and Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations. in people with Esthetic Restorations, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Esthetic Restorations
- What is being tested?
- One-step polishing system with nanohybrid resin composite restorations. and Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Mar 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient related criteria:
- Patients with good general health.
- Patients who agreed to the consent and committed to follow-up period
- No specific age range.
- Both genders.
- Low and moderate caries risk patients
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- Normal occlusion
- Tooth related criteria
- Fully erupted permanent anterior teeth with class IV.
- Active caries, fractures, or defective Restorations in anterior teeth.
Who cannot join
- Patient related criteria
- Patient with bad oral hygiene.
- Patients with tetracycline or fluorosis staining.
- Patients who could/would not participate in all times of follow-up.
- Patients participating in more than 1 dental study.
- Patient received fluoride varnish, or during orthodontic treatment.
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- Patients with tendency to do bleaching during the study.
- Heavy Smokers
- Patients who are alcoholic and addicted Tooth related criteria
- Untreated periodontal disease was not allowed
- Fully erupted anterior teeth with no defects
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
Cairo University
Giza, Manial
Dean of faculty of Dentistry, +(202)23634965, Dentmail@dentistry.cu.edu.eg
About this study
Official title: Esthetic Performance and Surface Roughness of Class IV Nanohybrid Composite Restorations Following One-step Versus Multistep Polishing Protocol: a Randomized Clinical Trial
This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Discoloration due to plaque accumulation and surface staining can lead to esthetic concerns, resulting in premature restoration replacement and increased costs. Prior research highlights that esthetic failures, such as color alterations and surface staining, are key reasons for the failure of anterior restorations. Given the contradictory findings in previous studies on finishing and polishing methods, this research seeks to determine whether one-step polishing system will have the same effect as the multistep system in terms of esthetic performance and surface roughness of nanohybrid resin composite class IV restorations. The main operator will compare between OneGloss (Shofu) the intervention and Super-Snap X-treme (Shofu) the comparator. Patients will be evaluated immediately following polishing then after 3 months, 6 months, and 12 months.
- Conditions
- Esthetic Restorations
- Being tested
- One-step polishing system with nanohybrid resin composite restorations., Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.
- Keywords
- Surface roughness, class IV, nanohybrid composite, multistep polishing system., one-step polishing system, surface staining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-step polishing system with nanohybrid resin composite restorations.Procedure or surgery
one-step polishing system using OneGloss by Shofu
Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.Procedure or surgery
A multi-step polishing system
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | One-step polishing system with nanohybrid resin composite restorations Receives: Procedure: One-step polishing system with nanohybrid resin composite restorations. |
| Compartor | Active comparator | Multistep system polishing system with nanohybrid resin composite restorations. Receives: Procedure: Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Luster (success rate)
Scoring system (ordinal) 5: Luster comparable to enamel 4: Slightly dull, not noticeable from speaking distance, some isolated pores 3: Dull surface but acceptable if covered with film of saliva, multiple pores on more that one-third of the surface 2: Rough surface, cannot be masked by saliva film, simple polishing not sufficient
1: Very rough, unacceptable plaque-retentive surface
Measured: 24hours, 3 months, 6months and 12 months
Secondary outcomes (4)
Surface Staining
Scoring system (ordinal) 5: No staining 4: Minor Staining, easily removable by polishing 3: Moderate surface staining that may also be present on other teeth, not esthetically unacceptable 2: Unacceptable surface staining, major intervention necessary
1: severe surface and/or subsurface staining, not acceptable for intervention
Measured: 24hours, 3 months, 6months and 12 months
Marginal Staining
Scoring system (ordinal) 5 No staining 4 Minor staining, easily removable by polishing 3 Moderate marginal staining, not esthetically unacceptable 2 Pronounced marginal staining; major intervention necessary
1 Deep marginal staining, not accessible for intervention
Measured: 24hours, 3 months, 6months and 12 months
Color Match
Scoring system (ordinal)
- Good color match, no difference in shade and translucency
- Minor Deviation
- Clear deviation but acceptable. Does not affect esthetic 3.1: More opaque 3.2: More translucent 3.3: Darker 3.4: Brighter
Measured: 24hours, 3 months, 6months and 12 months
Surface Roughness
Surface roughness means (Ra)
Measured: 24hours, 3 months, 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetic RestorationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noreen Amr Labib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732115
- Sponsor's protocol ID
- 20230084
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Performance and Surface Roughness of Class IV Nanohybrid Composite Restorations Following One-step Versus Multistep Polishing Protocol: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06732115
- Acronym / sponsor ID
- 20230084
- Conditions
- Esthetic Restorations
- Keywords
- Surface roughness, class IV, nanohybrid composite, multistep polishing system., one-step polishing system, surface staining
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Dec 2024 (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.
This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Discoloration due to plaque accumulation and surface staining can lead to esthetic concerns, resulting in premature restoration replacement and increased costs. Prior research highlights that esthetic failures, such as color alterations and surface staining, are key reasons for the failure of anterior restorations. Given the contradictory findings in previous studies on finishing and polishing methods, this research seeks to determine whether one-step polishing system will have the same effect as the multistep system in terms of esthetic performance and surface roughness of nanohybrid resin composite class IV restorations. The main operator will compare between OneGloss (Shofu) the intervention and Super-Snap X-treme (Shofu) the comparator. Patients will be evaluated immediately following polishing then after 3 months, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: One-step polishing system with nanohybrid resin composite restorations.One-step polishing system with nanohybrid resin composite restorations |
| Compartor | Active comparator | Procedure: Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.Multistep system polishing system with nanohybrid resin composite restorations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patient related criteria:
- Tooth related criteria
Key exclusion criteria (11 listed)
- Patient related criteria
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 polishing system with nanohybrid resin composite restorations.one-step polishing system using OneGloss by Shofu | Procedure or surgery | Intervention |
| Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.A multi-step polishing system | Procedure or surgery | Compartor |
Primary outcome
Surface Luster (success rate)
Time frame: 24hours, 3 months, 6months and 12 months
Scoring system (ordinal) 5: Luster comparable to enamel 4: Slightly dull, not noticeable from speaking distance, some isolated pores 3: Dull surface but acceptable if covered with film of saliva, multiple pores on more that one-third of the surface 2: Rough surface, cannot be masked by saliva film, simple polishing not sufficient 1: Very rough, unacceptable plaque-retentive surface
4 secondary outcomes
Surface Staining
Time frame: 24hours, 3 months, 6months and 12 months
Marginal Staining
Time frame: 24hours, 3 months, 6months and 12 months
Color Match
Time frame: 24hours, 3 months, 6months and 12 months
Surface Roughness
Time frame: 24hours, 3 months, 6months and 12 months
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 12 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Esthetic Restorations
Recruiting
Adhesive Cementation Materials and Techniques in Aesthetic Dentistry
Dental Veneers, Resin Cements
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.
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 polishing system with nanohybrid resin composite restorations. and Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations. in people with Esthetic Restorations, run by Cairo 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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Mar 2025. 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 Noreen A Labib, Masters Degree student (+201068487006, noreen.labib@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Luster (success rate) (time frame: 24hours, 3 months, 6months and 12 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 12 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.