Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?

Overview

The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.

Full Title of Study: “Is There a Possibility That Bulk Fill Glass Hybrid Restorative Materials Could Replace Composite Resins in Treating Permanent Teeth? : A Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 16, 2020

Detailed Description

The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.

Interventions

  • Other: Equia Forte HT+Equia Forte Coat
    • Restorations completed with these materials.

Arms, Groups and Cohorts

  • Active Comparator: Group 1
    • Equia system bulk fill glass hybrid material
  • Active Comparator: Group 2
    • Charisma Smart universal composite resin

Clinical Trial Outcome Measures

Primary Measures

  • marginal adaptation
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • marginal discoloration
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • color match
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • surface texture
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • secondary caries
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • postoperative sensitivity
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.
  • retention
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.

Secondary Measures

  • anatomic form
    • Time Frame: 2 weeks-12 months
    • According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted.

Participating in This Clinical Trial

Inclusion Criteria

  • The patient has no systemic disease – The patient should have good periodontal status – Teeth to be restored should be symptomless and vital – Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth – Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically Exclusion Criteria:

  • Xerostomia and bruxism; – Absence of adjacent and antagonist teeth; – Extremely poor oral hygiene, severe or chronic periodontitis; – Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology. – The patients who are undergoing orthodontic treatment

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Necmettin Erbakan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hazal Özer, Assist. Prof. – Necmettin Erbakan University

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