NCT07627295

Brief Summary

The goal of this clinical trial is to evaluate and compare. Impact of finishing/polishing systems on ormocer versus methacrylate-based bulk-fill flowable composite in Class V restorations: The main question it aims to answer is the following: Are there any differences between finishing/polishing systems on Ormocer versus methacrylate-based bulk-fill flowable composite?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
May 2026May 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 12, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 6, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Class V restorations;finishing and polishing;resin composite

Outcome Measures

Primary Outcomes (1)

  • FDI criteria score-aesthetic properties (A1 surface luster and surface texture; A2 Marginal staining; A3 color match), Functional (F1 Fracture/Retention; F2 marginal adaptation), biological (B1 caries at restoration margin)

    According to the revised 2023 World Dental Federation (FDI) criteria for, 1. Aesthetic properties Restorations will be evaluated for A1 (surface luster and texture), A2 (marginal staining), and A3 (color match). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. Unit of Measure: FDI score 2. Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation). Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. Unit of Measure: FDI score 3. Biological properties Restoration assessment of B1 (caries at restoration margin) according to the revised 2023 FDI criteria. Lower scores indicate better performance. Unit of Measure: FDI

    Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months

Study Arms (6)

Ormocer bulk-fill +one-step finishing/polishing system

EXPERIMENTAL

Class V was restored with an ormocer-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.

Other: one-step finishing and polishing system.

Ormocer bulk-fill + two-step finishing/polishing system

EXPERIMENTAL

Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.

Other: two-step finishing and polishing system.

Ormocer bulk-fill + three-step finishing/polishing system.

EXPERIMENTAL

Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.

Other: three-step finishing and polishing system.

Methacrylate bulk-fill + one-step finishing/polishing system.

EXPERIMENTAL

Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.

Other: one-step finishing and polishing system.

Methacrylate bulk-fill + two-step finishing/polishing system.

EXPERIMENTAL

Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.

Other: two-step finishing and polishing system.

Methacrylate bulk-fill+ three-step finishing/polishing system.

EXPERIMENTAL

Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.

Other: three-step finishing and polishing system.

Interventions

• Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a one-step finishing and polishing system.

Methacrylate bulk-fill + one-step finishing/polishing system.Ormocer bulk-fill +one-step finishing/polishing system

Each class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each class V restoration will be subjected to a two-step finishing and polishing system.

Methacrylate bulk-fill + two-step finishing/polishing system.Ormocer bulk-fill + two-step finishing/polishing system

Each Class V restoration will be restored with an ormocer-based bulk-fill flowable composite material or methacrylate-based restorative according to the manufacturer's instructions for use, and then each Class V restoration will be subjected to a three-step finishing and polishing system.

Methacrylate bulk-fill+ three-step finishing/polishing system.Ormocer bulk-fill + three-step finishing/polishing system.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Three pairs of buccal cervical supragingival carious lesions in anterior teeth
  • Complete and normal occlusion
  • Good oral hygiene
  • Willingness to attend follow-up and recall visits for 2 years

You may not qualify if:

  • Teeth requiring direct pulp capping
  • Poor oral hygiene or failure to complete the oral hygiene phase
  • Chronic periodontitis
  • Pulpitis or non-vital teeth
  • Current orthodontic treatment
  • Presence of parafunctional habits
  • Systemic diseases
  • Previous or ongoing bleaching procedures
  • Smoking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Study Officials

  • Doha M Zahran, master

    MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

    PRINCIPAL INVESTIGATOR
  • Maha Ebaya, PhD

    Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.

    STUDY DIRECTOR
  • asmaa abd allah, PhD

    Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University

    STUDY DIRECTOR
  • Abeer El-Embaby, PhD

    Professor, Conservative Dentistry Department,Faculty of Dentistry, Mansoura University

    STUDY CHAIR

Central Study Contacts

doha m zahran, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

June 4, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations