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Enrolling by invitation Not applicable

Clinical Evaluation of Wear Resistance and Bioactivity of Self Cured Bioactive Resin Composite

NCT07262086 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-11-22
Last updated
2025-12-22

Condition(s) studied

Dental CariesClass II Dental Caries

Investigational drug(s) / intervention(s)

Resins, Composite nanohybridResins, Composite bioactive

Resins, Composite nanohybrid: Placement of light-cured nanohybrid resin composite for Class II restorations, following manufacturer's instructions

Resins, Composite bioactive: Placement of self-cured bioactive resin composite for Class II restorations, following manufacturer's instructions

Study summary

Introduction:

Resin-based composites (RBCs) have become the gold standard in restorative dentistry due to their superior aesthetics, adhesion, and minimally invasive application. However, wear remains a critical drawback, compromising their longevity and clinical performance. Various techniques have been suggested to measure the clinical performance of (RBCs). Recent advancements in digital dentistry, such as intraoral scanning, offer a more precise and efficient approach for quantitative wear assessment.

Aim:

This study aims to evaluate wear resistance and bioactivity of self cured bioactive resin composite vs nanhybrid resin composite.

Methodology:

Twelve healthy patients with 24 carious molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with conventional nanohybrid RBC (M1). Meanwhile, the second tooth will be restored by self-cure bioactive RBC (M2). Then, wear resistance will be evaluated by intraoral scanner immediately after restoration (T0), six months later (T1), after 12 months (T2), 18 months (T3) and 24 months (T4). Software analysis will be done by superimposing the 3D digital impression and evaluate the restoration wear by calculating the 3D volume loss.

Also, bioactivity of the restoration will be measured by measuring the mineral density beneath the restoration. Digital radiographic images will be taken for the restoration by parallel technique and grey scale of the pixels under restoration will be measured by software immediately after restoration (D0), one month later (D1) and after 3 months (D2).

Eligibility

Sex
ALL
Min age
21 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients with vital two molar teeth with compound class II deep carious lesions. * Both males and females will be included. * Patients with good general health. * Patients with good oral hygiene. * Co-operative patients. * Absence of spontaneous pain, mobility or tenderness on percussion. * Radiographically: no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal ligament space. Exclusion Criteria: * Patients with systemic disease. * Patients with severe or chronic periodontitis. * Patients having allergy to the materials used in this trial. * Nonfunctioning teeth. * Teeth with any pathologic pulpal changes. * Teeth with previous restorations. * Teeth with surface loss due to non carious lesions.

Primary outcome measure(s)

  • Assessment of the bioactivity — immediately after restoration (D0) ; one month (D1) and three months (D2)
    Bioactivity of each examined restoration will be determined by the evaluation of mineral density beneath the tested materials. Immediately after restoration (D0), an image plate digital sensor (Xios XG Supreme, Dentsply Sirona, UK) will be used for transmitting the radiographic image of the selected tooth to the computer. Later, each restoration will be examined at standardized follow-up periods. All the radiographs will be evaluated for the outcome by a software (ImageJ software, NIH, USA).
  • wear resistance — Immediately after restoration, six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4).
    A digital impression will be taken immediately after restoration (T0) using an intraoral scanner (Helios 600 intraoral scanner, Eighteeth, Changzhou, China). To ensure optimal performance and accuracy, the scanner underwent regular calibration before scanning each patient, following the manufacturer's recommendations. During the scanning procedure, the device will be positioned at a 90° angle for the occlusal surface and at 45° angles for both buccal and lingual surfaces. Later on, each restoration will be examined at standardized follow-up periods; six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4). The 3D impressions will be analyzed using a software (Geomagic software, 3D Systems Inc., USA) program and the impressions of each two consultative visits will be superimposed to determine the wear volume loss (mm3)

Trial sites (1)

FacilityCityRegionStatus
Suez Canal University Ismailia Ismalia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262086 on ClinicalTrials.gov ↗ ← All trials in Egypt