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

Repair Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500430
• Other study ID #: repair defective restoration
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 1, 2024
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Repair

Intervention

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).

Locations

Country	Name	City	State
Egypt	Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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