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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Restoration

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42090
    • Merve Abakli Inci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Equia Group; Equia system bulk fill glass hybrid material	Other: Restoration; Restorations completed with these materials.; Other Names: Restorative Interventions
ACTIVE_COMPARATOR: Charisma Group; Charisma Smart universal composite resin	Other: Restoration; Restorations completed with these materials.; Other Names: Restorative Interventions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomic form	According to the amended USPHS (United States Public Health Service) criteria, a direct clinical evaluation was conducted. The scale: Alfa Bravo Charlie	2 weeks-12 months

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): August 16, 2020
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Clinical Trial; Composite Resins; Glass Ionomer Cements; Permanent Dental Restoration
• Other Study ID Numbers: 2020/332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research will be published soon.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No