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

NCT07262086 | Enrolling By Invitation DMC

• 1 other identifier: 1016/2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dental Caries; Class II Dental Caries

Keywords

dental caries; wear resistance; bioactive resin composite

Outcome Measures

Primary Outcomes (2)

• Assessment of the bioactivity

  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).

  immediately after restoration (D0) ; one month (D1) and three months (D2)

• wear resistance

  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)

  Immediately after restoration, six months (T1), twelve months (T2), eighteen months (T3) and twenty-four months (T4).

Study Arms (2)

Light cured nanohybrid RBC restorations

SHAM COMPARATOR

Conventional nanohybrid composite placement for Class II restorations

Procedure: Resins, Composite nanohybrid

"Self-cured Bioactive Resin Composite."

EXPERIMENTAL

Self-cured bioactive composite placement for Class II restorations

Procedure: Resins, Composite bioactive

Interventions

Resins, Composite nanohybrid PROCEDURE

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

Also known as: conventional nanohybrid resin composite

Light cured nanohybrid RBC restorations

Resins, Composite bioactive PROCEDURE

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

Also known as: bioactive composite

"Self-cured Bioactive Resin Composite."

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Ismalia, Egypt

Location

Related Publications (1)

• Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.

  PMID: 39653674 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Resins, Plant

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: "The IPD will be available beginning 6 months after publication of the main results, and for a period of 5 years thereafter. Data will be de-identified before sharing
• Access Criteria: "Qualified researchers can request access to the data by submitting a formal proposal to the Principal Investigator (PI) that describes the research question, required data, and planned analysis. Access will be granted following a review by the study steering committee and execution of a data sharing agreement

Locations

EG (1)