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

February 5, 2024 updated by: Ahmed Salah Abdel-Aty hassan, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 methacrylate.

  • Rampant caries.

    • Disabilities patient
    • Pregnancy
    • Heavy smoking.
    • Xerostomia.
    • Lack of compliance.
    • Evidence of parafunctional habits.
    • Temporomandibular joint disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: surface pretreatment sandblasting

Air abrasion sandblasting aluminum oxide particles (Al2O3) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan).

The surface treatment for aged composite will be applied according to manufacturer instructions.

Repairing with bioactive injectable composite, Beautiful 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) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful 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) Aqua Care single (London, UK) will be done for the defective area then repairing with bioactive injectable composite, Beautiful Flow Plus X F00 (Shofu, Japan).
Other Names:
  • sandblasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the clinical performance
Time Frame: Change from the baseline at 12 months

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

Measuring Unit:

Scoring system (Ordinal):

  • Alfa
  • Bravo
  • Charlie
  • Delta
Change from the baseline at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • repair defective restoration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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