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Evaluation of Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05500430
Collaborator
(none)
39
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair.

Condition or Disease Intervention/Treatment Phase
  • Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)
 N/A

Detailed Description

First the rationale for the repair, rather than the replacement of defective direct composite restorations proved a less invasive procedure with decreased tooth loss avoiding weakening and overtreatment of tooth. Less traumatic or stressful than replacement for patients with good acceptance; Increased longevity of the restoration; Reduction of potentially harmful effects on the dental pulp and Less risk of iatrogenic damage to adjacent teeth.

Secondary using surface treatment strategies aim to prepare a clean surface with high surface energy to provide better wettability with adequate surface roughness and surface area by removing the superficial layer of the aged composite which lead to increase integrity between old and new resin restoration.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Bioactive Injectable Hybrid Resin Composite Restoration With or Without Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration, A Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: surface pretreatment sandblasting

Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautifil Flow Plus X F00 (Shofu, Japan). The surface treatment for aged composite will be applied according to manufacturer instructions. Repairing with bioactive injectable composite, Beautifil Flow Plus X F00(Shofu, Japan) The material will be applied according to manufacturer instructions. After shade selection incremental insertion in layers not exceeding 2 mm and light curing for 10 sec using 3M Eliper curing unite (Elipar Deepcure-S, 3M).

Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)
Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautifil Flow Plus X F00 (Shofu, Japan).
Other Names:
  • sandblasting

    		•
    Active Comparator: Repairing with conventional nanohybrid composite

    The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions.

    Device: Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK)
    Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautifil Flow Plus X F00 (Shofu, Japan).
    Other Names:
  • sandblasting

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the clinical performance [Change from the baseline at 12 months]

      Change in the clinical performance Measured using modified USPHS criteria for clinical evaluation of restoration failure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Co-operative patients approving to participate in the trial.

    • patient with occlusal defects class I or class II composite resin restorations indicated for repair.

    Exclusion Criteria:

    • Allergic history concerning methacrylates.

    • Rampant caries.

    • Disabilities patient

    • Pregnancy

    • Heavy smoking.

    • Xerostomia.

    • Lack of compliance.

    • Evidence of parafunctional habits.

    • Tempromandibular joint disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: heba hamza, Professor, heba.hamza@dentistry.cu.edu.eg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Salah Abdel-Aty hassan, Assistant lecturer, conservative department, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05500430
    Other Study ID Numbers:
    • repair defective restoration
    First Posted:
    Aug 15, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Salah Abdel-Aty hassan, Assistant lecturer, conservative department, Cairo University
    repair, defective restoration , sandblasting

    Study Results

    No Results Posted as of Aug 15, 2022