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

NCT06732115 | Not Yet Recruiting

• 1 other identifier: 20230084
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Surface roughness; class IV; nanohybrid composite; multistep polishing system.; one-step polishing system; surface staining

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Surface Staining

  24hours, 3 months, 6months and 12 months

• Marginal Staining

  24hours, 3 months, 6months and 12 months

• Color Match

  24hours, 3 months, 6months and 12 months

• Surface Roughness

  24hours, 3 months, 6months and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

One-step polishing system with nanohybrid resin composite restorations

Procedure: One-step polishing system with nanohybrid resin composite restorations.

Compartor

ACTIVE COMPARATOR

Multistep system polishing system with nanohybrid resin composite restorations.

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

Interventions

One-step polishing system with nanohybrid resin composite restorations. PROCEDURE

one-step polishing system using OneGloss by Shofu

Intervention

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

A multi-step polishing system

Compartor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Manial, Egypt

Location

Central Study Contacts

Noreen A Labib, Masters Degree student

CONTACT

+201068487006; noreen.labib@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student in operative department, faculty of dentistry, Cairo University

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 13, 2024
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)