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Impact of Finishing/Polishing Systems on Ormocer VS Methacrylate Based Bulk Fill Flowable Composite in Class V

31. Mai 2026 aktualisiert von: Mansoura University

Impact of Finishing/Polishing Systems on Ormocer Versus Methacrylate Based Bulk Fill Flowable Composite in Class V Restorations: Clinical Study and Laboratory Investigations

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?

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study will evaluate the impact of three different finishing/polishing systems on ormocer versus methacrylate-based bulk-fill flowable composite in Class V restorations on adult patients' anterior teeth. First, investigators will use an ormocer and methacrylate-based bulk-fill flowable composite in Class V restorations in anterior teeth. Then each patient will receive three different finishing/polishing systems. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess the restorations according to the FDI criteria as esthetic properties (A1 surface luster and surface texture; A2 marginal staining; A3 color match), functional (F1 fracture/retention; F2 marginal adaptation), and biological (B1 caries at restoration margin). The results will help dentists choose the most appropriate finishing/polishing systems for Class V restoration cases.

Studientyp

Interventionell

Einschreibung (Geschätzt)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Ägypten
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Ägypten, 35516
        • Rekrutierung
        • Faculty of Dentistry, Mansoura University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ormocer bulk-fill +one-step finishing/polishing system
Class V was restored with an ormocer-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
Sonstiges: one-step finishing and 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 one-step finishing and polishing system.
Experimental: Ormocer bulk-fill + two-step finishing/polishing system
Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
Sonstiges: two-step finishing and 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.
Experimental: Ormocer bulk-fill + three-step finishing/polishing system.
Class V restored with an ormocer-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
Sonstiges: three-step finishing and 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.
Experimental: Methacrylate bulk-fill + one-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a one-step finishing and polishing system.
Sonstiges: one-step finishing and 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 one-step finishing and polishing system.
Experimental: Methacrylate bulk-fill + two-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a two-step finishing and polishing system.
Sonstiges: two-step finishing and 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.
Experimental: Methacrylate bulk-fill+ three-step finishing/polishing system.
Class V restored with methacrylate-based bulk-fill restorative material, then subjected to a three-step finishing and polishing system.
Sonstiges: three-step finishing and 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: Post-restoration baseline (2 weeks), 6, 12, 18, and 24 months

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mansoura University

Ermittler

  • Hauptermittler: Doha M Zahran, master, MSc Postgraduate student ,Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
  • Studienleiter: Maha Ebaya, PhD, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
  • Studienleiter: asmaa abd allah, PhD, Assistant Professor, Conservative Dentistry Department, Faculty of Dentistry, Mansoura University
  • Studienstuhl: Abeer El-Embaby, PhD, Professor, Conservative Dentistry Department,Faculty of Dentistry, Mansoura University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Mai 2026

Primärer Abschluss (Geschätzt)

1. Mai 2028

Studienabschluss (Geschätzt)

1. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Mai 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • MD250825

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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