Evaluation of Performance and Occlusal Wear of Low Shrinkage Giomer Compared to Nanohybrid Resin Composite

Caries Class II Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949502
• Other study ID #: Low shrinkage giomer
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: February 2026

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Marwa AbdelHafez, MS.C
• Phone: 00201002894668
• Email: Marwa.abdelHafez[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aim of this study is to assess clinical performance and occlusal wear resistance of low shrinkage Giomer and Nanohybrid Resin Composite in proximal restorations using revised FDI (World Dental Federation) criteria and digital intra-oral scanner.

Two different restorative materials will be evaluated after two years for fracture, retention and occlusal wear. Furthermore, the rest of the revised FDI Criteria including functional (marginal adaptation, proximal contact point, form and contour, occlusion and occlusal wear) , biological (caries at restoration margin (CAR), dental hard tissue defects at restoration margin and postoperative hypersensitivity/pulp status) and esthetic properties (surface luster and surface texture, marginal staining and color match) will be also evaluated.

The first material is based on the giomer technology which is a true hybrid between nano-hybrid resin composite and glass ionomer. The comparator will be a nano-hybrid resin composite.

Examination and selection of all patients will be done. Teeth with proximal, primary carious lesions will be selected. Rubber dam isolation will be done followed by preparation of Class II cavities and placement of restorative material according to the randomization sequence.

Low-shrinkage bioactive material will be applied according to the manufacturer's instructions. For the comparator group, nano-hybrid resin composite will be also applied according to the manufacturer's instructions. Restorations will evaluated at baseline, after six, 12, 18 and 24 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries Class II

Intervention

Drug:
• Beautifil II LS (Low-Shrinkage)
low shrinkage bioactive material Giomer
• 3M Filtek Z250 XT Universal
Universal Nano-hybrid composite

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional properties (F1) Fracture of material and retention according to revised FDI (World Dental Federation) criteria. Measured by visual examination and short air drying.	Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).	24 months
Secondary	Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software.	Method of aggregation is Mean (SD) (parametric) or Median (Range) (Non-parametric). Measuring unit is Microns.	24 months.
Secondary	Functional properties according to revised FDI (World Dental Federation) criteria.	Functional properties: F2: Marginal adaptation measured by visual examination, short air drying, 250 µm probe.; F3:Proximal contact point measured by visual examination and 25/50/100 µm blades.; F4: Form and contour measured by visual examination. F5: Occlusion and occlusal wear measured by visual examination and articulation paper.; Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).	24 months.
Secondary	Biological properties according to revised FDI criteria.	Biological properties: B1: Caries at restoration margin (CAR) measured by visual examination, short air drying, and 250 µm probe.; B2: Dental hard tissue defects at restoration margin measured by visual examination.; B3: Postoperative hypersensitivity reported by patient and pulp status tested with cold stimulus.; Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).	24 months.
Secondary	Aesthetic properties according to revised FDI criteria.	Aesthetic properties: A1: Surface luster and surface texture measured by visual examination and short air drying.; A2: Marginal staining measured by visual examination and short air drying. A3: color match measured by visual examination. Method of aggregation is frequency and percentage. Measuring unit is scoring system (Ordinal, scores 1-5). (1) Clinically excellent. (sufficient). (5) Clinically poor (entirely insufficient).	24 months.