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

Not Applicable

Not yet recruiting

• Conditions: Caries Class II
• Interventions: Drug: 3M Filtek Z250 XT Universal; Drug: Beautifil II LS (Low-Shrinkage)

• Registration Number: NCT05949502
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Study Start: 2023-08
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano-hybrid resin composite	3M Filtek Z250 XT Universal	Nano-hybrid resin composite will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. Composite increments will be adapted obliquely on each cusp. This will be followed by light curing for 40 seconds using light curing unit of each increment till the whole cavity is filled.
Low shrinkage giomer.	Beautifil II LS (Low-Shrinkage)	Low-shrinkage bioactive material (giomer) will be applied according to the manufacturer's instructions. Centripetal technique will be performed to restore the proximal wall followed by oblique incrementation of approximately 2 mm thick composite resin. This will be followed by light curing of each increment for 40 seconds using light curing unit till the whole cavity is filled.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
Biological properties according to revised FDI criteria.	24 months.	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).
Quantitative occlusal restoration wear by Digital Intra-oral scanner and Geometrical subtraction software.	24 months.	Method of aggregation is Mean (SD) (parametric) or Median (Range) (Non-parametric). Measuring unit is Microns.
Functional properties according to revised FDI (World Dental Federation) criteria.	24 months.	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).
Aesthetic properties according to revised FDI criteria.	24 months.	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).