Clinical trial

Evaluation of Performance and Occlusal Wear of Low Shrinkage Giomer Compared to Nanohybrid Resin Composite in Proximal Restorations After Two Years: A Randomized Clinical Trial.

Name

Low shrinkage giomer

Description

A clinical trial, comparing the clinical performance and occlusal wear resistance of two different restorative materials in restoring proximal caries in permanent posterior teeth. One is based on giomer technology and the other is nano-hybrid resin composite.

Trial arms

Trial start

2023-08-01

Estimated PCD

2025-12-01

Trial end

2026-02-01

Status

Not yet recruiting

Treatment

Beautifil II LS (Low-Shrinkage)

low shrinkage bioactive material Giomer

Arms:

Low shrinkage giomer.

Other names:

low shrinkage Giomer

3M Filtek Z250 XT Universal

Universal Nano-hybrid composite

Arms:

Nano-hybrid resin composite

Other names:

Nano-hybrid composite

Size

Primary endpoint

Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying.

24 months

Eligibility criteria

Inclusion Criteria: * Inclusion criteria for patients * Patient's age ranging from 19-30 * Good oral hygiene. * Patients who have stable occlusion. * Patients who could be present for further periodic follow-ups. * Possibility for application of rubber dam during restoration. * Patient compliance. * Inclusion criteria for Teeth * Vital first and second molars, with compound Class II lesions. * The selected teeth should be in occlusion with natural dentition and having proximal contact with adjacent teeth. * Healthy periodontium. Exclusion Criteria: * Exclusion criteria for patients * Poor oral hygiene. * Patients with high caries index or high plaque index. * Patients with periodontal problems. * Heavy bruxism habit or presence of any parafunctional habits. * Any allergic reactions against any components of the materials to be used in the study. * History of severe medical complications such as xerostomia. * Pregnant or lactating women. * Participating in another clinical trial. * Exclusion criteria for teeth * Fractured or evidently cracked teeth. * Defective restorations adjacent or opposite the selected tooth for research. * Atypical extrinsic staining of teeth. * Teeth with defects or lesions requiring other operative interventions. * Teeth with pulpal pain. * Teeth with periapical lesions. * Root Canal treated teeth. * Mobile Teeth. * Non-functioning teeth with no opposing tooth. * Signs of severe attrition. * Heavy occlusion. * Periodontally affected teeth.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

Updated at

2023-07-18

1 organization

2 products

1 indication

Organization

Product

Indication

Product