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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries Class II
• Intervention / Treatment: Drug: Beautifil II LS (Low-Shrinkage); Drug: 3M Filtek Z250 XT Universal

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 Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa AbdelHafez, MS.C; Phone Number: 00201002894668; Email: Marwa.abdelHafez@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low shrinkage giomer.; 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.	Drug: Beautifil II LS (Low-Shrinkage); low shrinkage bioactive material Giomer; Other Names: low shrinkage Giomer
Active Comparator: Nano-hybrid resin composite; 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.	Drug: 3M Filtek Z250 XT Universal; Universal Nano-hybrid composite; Other Names: Nano-hybrid composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Low-shrinkage Giomer; Nano-hybrid composite; Revised FDI criteria
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Attrition
• Other Study ID Numbers: Low shrinkage giomer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No