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

NCT ID: NCT05949502

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2026-02-28

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.

Conditions

Caries Class II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Beautifil II LS (Low-Shrinkage)

Intervention Type: DRUG

low shrinkage bioactive material Giomer

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.

Group Type: ACTIVE_COMPARATOR

3M Filtek Z250 XT Universal

Intervention Type: DRUG

Universal Nano-hybrid composite

Interventions

Beautifil II LS (Low-Shrinkage)

low shrinkage bioactive material Giomer

Intervention Type: DRUG

3M Filtek Z250 XT Universal

Universal Nano-hybrid composite

Intervention Type: DRUG

Other Intervention Names

low shrinkage Giomer; Nano-hybrid composite

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omar Osama Shaalan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marwa AbdelHafez, MS.C

Role: CONTACT

Marwa.abdelHafez@dentistry.cu.edu.eg

00201002894668

Other Identifiers

Low shrinkage giomer

Identifier Type: -

Identifier Source: org_study_id