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NCT Number: NCT06732115

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

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.

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Key information

Conditions

Esthetic Restorations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-step polishing system with nanohybrid resin composite restorations.

Procedure

one-step polishing system using OneGloss by Shofu

Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.

Procedure

A multi-step polishing system

Primary outcomes

  1. 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

Secondary outcomes

  1. Surface Staining

    Time frame: 24hours, 3 months, 6months and 12 months

    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

  2. Marginal Staining

    Time frame: 24hours, 3 months, 6months and 12 months

    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

  3. Color Match

    Time frame: 24hours, 3 months, 6months and 12 months

    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

  4. Surface Roughness

    Time frame: 24hours, 3 months, 6months and 12 months

    Surface roughness means (Ra)

Study contacts

Contact information is provided by the study sponsor or research team.

Noreen A Labib, Masters Degree student

CONTACT

[email protected]

+201068487006

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2024
Registry last updated
Mar 12, 2025

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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