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Not yet recruiting NCT06732115

Effect of One-step Versus Multistep Polishing Protocol on Class IV Composite Restorations.

No phase Interventional Esthetic Restorations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One-step polishing system with nanohybrid resin composite restorations., Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations..
Who it may be relevant to
Registry conditions: Esthetic Restorations. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Esthetic Performance and Surface Roughness of Class IV Nanohybrid Composite Restorations Following One-step Versus Multistep Polishing Protocol: a Randomized Clinical Trial

Overview

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.

Interventions

  • Procedure One-step polishing system with nanohybrid resin composite restorations.
    one-step polishing system using OneGloss by Shofu
  • Procedure Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.
    A multi-step polishing system

Primary outcome measures

  • Surface Luster (success rate) [Time frame: 24hours, 3 months, 6months and 12 months]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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
  • Normal occlusion
  • Tooth related criteria
  • Fully erupted permanent anterior teeth with class IV.
  • Active caries, fractures, or defective Restorations in anterior teeth.

Exclusion criteria

  • 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT06732115 · 20230084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗