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

NCT05500430 | Completed DMC

• 1 other identifier: repair defective restoration
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Repair

Keywords

repair; defective restoration; sandblasting

Outcome Measures

Primary Outcomes (1)

• Change in the clinical performance

  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

Study Arms (2)

surface pretreatment sandblasting

EXPERIMENTAL

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)

Repairing with conventional nanohybrid composite

ACTIVE COMPARATOR

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)

Interventions

Air abrasion sandblasting aluminum oxide particles (Al2O3) AquaCare single (Velopex, Medivance Instruments Ltd., London, UK) DEVICE

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).

Also known as: sandblasting

Repairing with conventional nanohybrid composite; surface pretreatment sandblasting

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Co-operative patients approving to participate in the trial.
• patient with occlusal defects class I or class II composite resin restorations indicated for repair.

You may not qualify if:

• Allergic history concerning methacrylate.
• Rampant caries.
• Disabilities patient
• Pregnancy
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Evidence of parafunctional habits.
• Temporomandibular joint disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dentistry

Cairo, Egypt

Location

Study Officials

• heba hamza, Professor

  heba.hamza@dentistry.cu.edu.eg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, conservative department

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: January 20, 2022
• Primary Completion: October 20, 2023
• Study Completion: February 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

EG (1)