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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esthetic Restorations
• Intervention / Treatment: Procedure: One-step polishing system with nanohybrid resin composite restorations.; Procedure: Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noreen A Labib, Masters Degree student; Phone Number: +201068487006; Email: noreen.labib@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Manial
    • Giza, Manial, Egypt
      • Cairo University
      • Contact: Dean of faculty of Dentistry; Phone Number: +(202)23634965; Email: Dentmail@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; One-step polishing system with nanohybrid resin composite restorations	Procedure: One-step polishing system with nanohybrid resin composite restorations.; one-step polishing system using OneGloss by Shofu
Active Comparator: Compartor; Multistep system polishing system with nanohybrid resin composite restorations.	Procedure: Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations.; A multi-step polishing system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24hours, 3 months, 6months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	24hours, 3 months, 6months and 12 months
Surface Roughness	Surface roughness means (Ra)	24hours, 3 months, 6months and 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: nanohybrid composite; Surface roughness; class IV; multistep polishing system.; one-step polishing system; surface staining
• Other Study ID Numbers: 20230084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No